Functional Neurological Symptom DisorderTONICSNCT05829005
Trial Of Neurostimulation Treatment and Investigation for Causes of Functional Motor Symptoms: a Pilot Study
A study testing Transcranial magnetic stimulation (TMS) in people with Functional Neurological Symptom Disorder, run by King's College London at 1 site in United Kingdom.
Trial summary
A pilot randomised controlled trial (RCT) of single-pulse transcranial magnetic stimulation (TMS) over the motor cortex to investigate efficacy in improving motor FND symptoms and to make a preliminary investigation of predictors of response to TMS and potential mechanisms of action. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Functional Neurological Symptom Disorder
- What is being tested?
- Transcranial magnetic stimulation (TMS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 51 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Aug 2023to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) diagnosis of motor FND (i.e. presenting with weakness of at least one limb) made by consultant neurologist and/or neuropsychiatrist.
- Age ≥18yrs.
- Ability to give written informed consent.
Who cannot join
- Epilepsy (or considered high risk of epilepsy from medical history).
- Other contraindication to TMS (e.g. cochlear implants, metallic intracranial clips/surgery in last 12 months).
- Comorbid organic neurological condition.
- Pain as primary symptom.
- Previous treatment with TMS (for any condition).
- Non-fluent English speakers (if unable to accurately complete self-report questionnaires).
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- Major mental health disorder: current diagnosis of schizophrenia or bipolar disorder; current drug/alcohol dependence.
- History of factitious disorder.
- Currently involved in another trial.
- Pregnancy
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Institute of Psychiatry, Psychology & Neuroscience
London, London, se5 8af
About this study
Official title: Trial of Neurostimulation Treatment and Investigation for Causes of Functional Motor Symptoms: a Pilot Study
A pilot randomised controlled trial (RCT) of single-pulse transcranial magnetic stimulation (TMS) over the motor cortex to investigate efficacy in improving motor FND symptoms and to make a preliminary investigation of predictors of response to TMS and potential mechanisms of action.
Read the detailed description
This study is a pilot trial that will aim to determine if Transcranial Magnetic Stimulation (TMS) is an effective, tolerated and safe treatment for functional neurological disorder (FND) and to make a preliminary investigation of predictors of response to TMS and potential mechanisms of action.
This trial will be a 'randomised, two-arm, double-blind, parallel-arm study design. Randomised means that patients will be allocated to 'active' or 'inactive' treatment groups at random - this is done to minimise the chances of the characteristics of groups being different and influencing response to the different treatments. Double-blind means that the patients will not know which group they have been allocated to, and the assessors of response to treatment will be blinded, which will help reduce researcher 'bias' in assessing response. Parallel means that the treatment groups will occur alongside each other and patients will only have one of the treatments during the trial - unlike a 'crossover' design where patients will get both. However, after the trial, if a patient has received the 'inactive' treatment they will be offered the 'active' treatment if, after review by the clinician, such treatment is considered appropriate by the clinician.
The 'active' intervention is supra-threshold TMS that is so-called as it above the threshold needed to stimulate the primary motor cortex, the area of the brain known as 'M1' that when stimulated leads to contraction of limb muscles and can therefore make a weak limb move that the patient would otherwise not be able to move. This study postulates that it is the stimulation of a paralysed limb resulting in movement that is the active component of treatment, as it allows patients to relearn and re-experience normal movement, as well as providing proof of the possibility of the return of function.
An 'inactive' control arm is being used in this study as this is the standard way to show if, and how much, any response to the 'active' intervention might be due to chance. The investigators will be using sub-threshold TMS, so real TMS that will stimulate the motor cortex. This is different to other options for the control arm, such 'sham' TMS where no actual TMS pulse is delivered. Such sham devices deliver a similar sensation to the scalp and are designed to look the same as 'real' TMS devices so it is hard, and ideally impossible, for the patient to know whether they were getting real or sham treatment. This will also be delivered to the same location (primary motor cortex, ie. 'M1'). The location and number of pulses have been set at the same as the active treatment. The intensity of stimulation will necessarily be less, but will still result in a stimulus that is felt by the subject to maximise chances of successful blinding.
Importantly, and necessarily, details of what the two arms will involve are kept vague in the information sheet to maximise the chances of successful blinding of participants. There is genuine equipoise between these two proposed arms because, as yet, there is no evidence that the reported effects of TMS in the published case series are anything other than placebo. The one published feasibility RCT found no significant increase in subjective ratings of strength compared to placebo.
The use of blinded assessments of some clinician-rated measures and use of patient-rated outcomes (including the primary outcome measure) will reduce "researcher effects" and "researcher bias", as will use of the local (KCL) clinical trials unit (CTU) database system. During the trial, any changes in other treatments will be carefully documented at the start of treatment and at all subsequent assessments. No attempt will be made to standardise these or balance them between the arms other than randomisation but the effects of these, and other pertinent changes (e.g. other clinical parameters such as anxiety and depression scores) to see if they mediate outcomes.
Timetable
The research project will take approximately 12 months to complete after ethical approval. The investigators aim to randomise 60 patients to one of the treatment arms. The investigators anticipate being able to recruit at a rate of approximately 3 per week, therefore taking 20 weeks (5 months) to complete recruitment. This can be rounded up to 7 months to allow for slow initial recruitment whilst recruitment pathways are set up and for possible initial delays in starting first patients due to arranging mutually convenient times for consenting, assessing and first treatment session. Each patient will then take 5 months to complete the study, so the last patients will finish follow up 12 months after the first patient is recruited. There are no planned interim analyses/reports.
Study details
Recruitment
This will be from inpatient and outpatient settings in London.
The neuropsychiatry services of King's Health Partners (KHP). KHP is an Academic Health Sciences Centre comprising the National Health Service (NHS) Foundation Trusts associated with King's College London (KCL) directly serving 2 million patients in South East London. KHP has two regional neurosciences centres at King's College Hospital (KCH) and St.Thomas'/Guys Hospitals NHS foundation trusts. They will also be recruited from South West London \& St George's Mental Health NHS Trust (SWLSTG) and University College London Hospitals NHS Foundation Trust (UCLH). The South London and Maudsley NHS Foundation Trust (SLaM) is the UK's largest Mental Health Trust. All 3 trusts receive many FND referrals from the local population but also from the South East of England and beyond. Assessments will be in private rooms at the relevant hospitals or the Institute of Psychiatry, Psychology and Neuroscience (IoPPN - a faculty of KCL at the Denmark Hill campus next to KCH and Maudsley Hospitals). TMS treatments will be in specialist treatment rooms either at KCH (department of neurophysiology) or IoPPN (department of psychosis studies).
Suitable patients will be identified by the clinical team involved in their care who will inform them about the study and either give them directly (in the clinic or on the ward) or send them by post, the information sheet about the study and invite them to get in touch with a member of the research team as detailed in the information sheet. If the patient is seen face-to-face by the clinician they will ask if the patient is willing for their details to be passed on to the research team so they can contact them directly by their preferred method of contact (post, phone or email). If the patient is sent an information sheet they will be told they will receive a phone call following up the letter within 2 weeks of receiving it to enquire as to whether they are interested in taking part, with reassurance that there will be no further contact from the research team if they do not wish to find out more about the study which they can convey to the research team when called on the phone (or do beforehand by contacting the research team via mail, email or phone)
60 patients are widely considered a standard sample for such a pilot study.
Patient visits, assessments and treatments:
The full project protocol (attached to this application), and later sections of this form, give full details of the timing of visits/participants' potential flow through the study, assessment forms/measures and the technical specifications of the treatments.
In summary, 60 patients will undergo a maximum of 5 visits to the Denmark Hill campus (with an approximate length of time of visit):
Visit A - for Screening +/- consent (15 minutes) Visit B - for Consent (if not already done) / Baseline assessments (2 hours) Visit C - for 1st Treatment session + pre \& post-treatment assessments (2 hours) Visit D - for 2nd Treatment session + pre \& post-treatment assessments (2 hours) Visit E - for 1st (interim) follow up for outcome assessment (1-2 hours) Visit F - for 2nd (final) follow up assessment (1-2 hours)
Visit A could be conducted by phone (and consent delayed to visit B) or combined with visit B to suit patient preference and the circumstances of recruitment. Visits E and F could be carried out as home visits or by telephone as required.
The start of treatment (visit C) will be a maximum of 2 weeks after Baseline assessments (visit B) and randomisation will take place immediately before the first treatment session. The 2nd treatment (visit D) is between 4-20 days after the 1st treatment (visit C). The follow-up assessments (visits D and E) are 1 and 3 months after the 1st treatment session (visit C).
Some assessments, such as those covering fixed characteristics (e.g. demographics) or historical details (e.g. medical, psychiatric and treatment history) will be performed only once at baseline. Other assessments such as symptoms and other changeable characteristics will be performed serially. See protocol for full details.
Both treatment arms involved delivering 120 singles pules of TMS with a circular coil to the motor cortex (M1), the first 100 of which will be used to determine motor threshold (MT) but not generate twitch of any muscle that can be seen or felt by the patient. For the active arm, the final 20 pulses will be 'supra-motor threshold' (120% of MT) in that they will cause a palpable contraction of the muscles and a visible movement of the weak limb that is confirmed by the patient. For the inactive arm, these final 20 pulses will be a 'sub-motor threshold' (80% of MT) that won't cause a palpable or visible contraction of the weak limb. No specific suggestion of recovery will be used in either arm beyond that inherent in a trial of a novel therapy - i.e. no 'enhancement' of the placebo effect will be utilised.
At the end of the final follow up patients will be unblinded and a full debrief will be given by the PI. If they were in the inactive treatment arm the possibility of receiving sessions of active treatment will be discussed with them - and if the patient and the clinician both agree this indicated it will then be offered to the patient.
- Conditions
- Functional Neurological Symptom Disorder
- Being tested
- Transcranial magnetic stimulation (TMS)
- Keywords
- Functional neurological disorder
- Medical subject headings
- Conversion Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial magnetic stimulation (TMS)Device
TMS is a form of 'non-invasive brain stimulation', i.e. it is a way of stimulating the brain from outside the head. It works by holding a magnetic coil approximately the size of a small side plate against the head (it rests on the scalp) which then delivers magnetic pulses that stimulate the underlying brain. It was developed over 30 years ago and has been increasingly used to treat a number of neurological and psychiatric disorders. It is considered a relatively safe and generally well-tolerated treatment.
| Study group | Role | What they receive |
|---|---|---|
| Active arm | Active comparator | The location and number of pulses will be set. The intensity of stimulation will be felt by the subject. 120 stimuli - including at least 20 supra (motor) threshold stimuli causing movement of the affected limb. Receives: Device: Transcranial magnetic stimulation (TMS) |
| Inactive/control arm | Sham comparator | The location and number of pulses have been set at the same as the active treatment. The intensity of stimulation will necessarily be less but will still result in a stimulus that is felt by the subject to maximise chances of successful blinding. 120 stimuli - no stimuli of sufficient intensity to produce movement. Receives: Device: Transcranial magnetic stimulation (TMS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adapted Patient Clinical Global Impression of Improvement (CGI-I) scale
Adapted Patient Clinical Global Impression of Improvement (CGI-I) scale rated by the patient is a 7-point scale of improvement from 'very much improved' to 'very much worse'. 'Very much improved' means a better outcome.
Measured: immediately before treatment 1
Adapted Patient Clinical Global Impression of Improvement (CGI-I) scale
Adapted Patient Clinical Global Impression of Improvement (CGI-I) scale rated by the patient is a 7-point scale of improvement from 'very much improved' to 'very much worse'. 'Very much improved' means a better outcome.
Measured: immediately after treatment 1
Adapted Patient Clinical Global Impression of Improvement (CGI-I) scale
Adapted Patient Clinical Global Impression of Improvement (CGI-I) scale rated by the patient is a 7-point scale of improvement from 'very much improved' to 'very much worse'. 'Very much improved' means a better outcome.
Measured: immediately before treatment 2
Adapted Patient Clinical Global Impression of Improvement (CGI-I) scale
Adapted Patient Clinical Global Impression of Improvement (CGI-I) scale rated by the patient is a 7-point scale of improvement from 'very much improved' to 'very much worse'. 'Very much improved' means a better outcome.
Measured: immediately after treatment 2
Adapted Patient Clinical Global Impression of Improvement (CGI-I) scale
Adapted Patient Clinical Global Impression of Improvement (CGI-I) scale rated by the patient is a 7-point scale of improvement from 'very much improved' to 'very much worse'. 'Very much improved' means a better outcome.
Measured: one-month follow-up
Adapted Patient Clinical Global Impression of Improvement (CGI-I) scale
Adapted Patient Clinical Global Impression of Improvement (CGI-I) scale rated by the patient is a 7-point scale of improvement from 'very much improved' to 'very much worse'. 'Very much improved' means a better outcome.
Measured: three-month follow-up
Secondary outcomes (76)
Adapted Outcome Assessor Clinical Global Impression of Improvement (CGI-I) scale
Adapted Patient Clinical Global Impression of Improvement (CGI-I) scale rated by the outcome assessor is a 7-point scale of improvement from 'very much improved' to 'very much worse'. 'Very much improved' means a better outcome.
Measured: immediately before treatment 1
Adapted Outcome Assessor Clinical Global Impression of Improvement (CGI-I) scale
Adapted Patient Clinical Global Impression of Improvement (CGI-I) scale rated by the outcome assessor is a 7-point scale of improvement from 'very much improved' to 'very much worse'. 'Very much improved' means a better outcome.
Measured: immediately after treatment 1
Adapted Outcome Assessor Clinical Global Impression of Improvement (CGI-I) scale
Adapted Patient Clinical Global Impression of Improvement (CGI-I) scale rated by the outcome assessor is a 7-point scale of improvement from 'very much improved' to 'very much worse'. 'Very much improved' means a better outcome.
Measured: immediately before treatment 2
Adapted Outcome Assessor Clinical Global Impression of Improvement (CGI-I) scale
Adapted Patient Clinical Global Impression of Improvement (CGI-I) scale rated by the outcome assessor is a 7-point scale of improvement from 'very much improved' to 'very much worse'. 'Very much improved' means a better outcome.
Measured: immediately after treatment 2
Adapted Outcome Assessor Clinical Global Impression of Improvement (CGI-I) scale
Adapted Patient Clinical Global Impression of Improvement (CGI-I) scale rated by the outcome assessor is a 7-point scale of improvement from 'very much improved' to 'very much worse'. 'Very much improved' means a better outcome.
Measured: one-month follow-up
Adapted Outcome Assessor Clinical Global Impression of Improvement (CGI-I) scale
Adapted Patient Clinical Global Impression of Improvement (CGI-I) scale rated by the outcome assessor is a 7-point scale of improvement from 'very much improved' to 'very much worse'. 'Very much improved' means a better outcome.
Measured: three-month follow-up
Adapted Carer Clinical Global Impression of Improvement (CGI-I) scale
Adapted Patient Clinical Global Impression of Improvement (CGI-I) scale rated by the carer is a 7-point scale of improvement from 'very much improved' to 'very much worse'. 'Very much improved' means a better outcome.
Measured: immediately before treatment 1
Adapted Carer Clinical Global Impression of Improvement (CGI-I) scale
Adapted Patient Clinical Global Impression of Improvement (CGI-I) scale rated by the carer is a 7-point scale of improvement from 'very much improved' to 'very much worse'. 'Very much improved' means a better outcome.
Measured: immediately after treatment 1
Adapted Carer Clinical Global Impression of Improvement (CGI-I) scale
Adapted Patient Clinical Global Impression of Improvement (CGI-I) scale rated by the carer is a 7-point scale of improvement from 'very much improved' to 'very much worse'. 'Very much improved' means a better outcome.
Measured: immediately before treatment 2
Adapted Carer Clinical Global Impression of Improvement (CGI-I) scale
Adapted Patient Clinical Global Impression of Improvement (CGI-I) scale rated by the carer is a 7-point scale of improvement from 'very much improved' to 'very much worse'. 'Very much improved' means a better outcome.
Measured: immediately after treatment 2
Adapted Carer Clinical Global Impression of Improvement (CGI-I) scale
Adapted Patient Clinical Global Impression of Improvement (CGI-I) scale rated by the carer is a 7-point scale of improvement from 'very much improved' to 'very much worse'. 'Very much improved' means a better outcome.
Measured: one-month follow-up
Adapted Carer Clinical Global Impression of Improvement (CGI-I) scale
Adapted Patient Clinical Global Impression of Improvement (CGI-I) scale rated by the carer is a 7-point scale of improvement from 'very much improved' to 'very much worse'. 'Very much improved' means a better outcome.
Measured: three-month follow-up
Strength patient ratings
Strength ratings assessed by the patient is a 5-point scale of strength from 'No weakness at all' to 'Very severe weakness'. 'No weakness at all' means a better outcome.
Measured: immediately before treatment 1
Strength patient ratings
Strength ratings assessed by the patient is a 5-point scale of strength from 'No weakness at all' to 'Very severe weakness'. 'No weakness at all' means a better outcome.
Measured: immediately after treatment 1
Strength patient ratings
Strength ratings assessed by the patient is a 5-point scale of strength from 'No weakness at all' to 'Very severe weakness'. 'No weakness at all' means a better outcome.
Measured: immediately before treatment 2
Strength patient ratings
Strength ratings assessed by the patient is a 5-point scale of strength from 'No weakness at all' to 'Very severe weakness'. 'No weakness at all' means a better outcome.
Measured: immediately after treatment 2
Strength patient ratings
Strength ratings assessed by the patient is a 5-point scale of strength from 'No weakness at all' to 'Very severe weakness'. 'No weakness at all' means a better outcome.
Measured: one-month follow-up
Strength patient ratings
Strength ratings assessed by the patient is a 5-point scale of strength from 'No weakness at all' to 'Very severe weakness'. 'No weakness at all' means a better outcome.
Measured: three-month follow-up
Dynamometer
Strength ratings measured by dynamometer
Measured: immediately before treatment 1
Dynamometer
Strength ratings measured by dynamometer
Measured: immediately after treatment 1
Dynamometer
Strength ratings measured by dynamometer
Measured: immediately before treatment 2
Dynamometer
Strength ratings measured by dynamometer
Measured: immediately after treatment 2
Dynamometer
Strength ratings measured by dynamometer
Measured: one-month follow-up
Dynamometer
Strength ratings measured by dynamometer
Measured: three-month follow-up
Change from baseline computerised attention tasks
attention task will be tested using a computer
Measured: one-month follow-up
Change from baseline computerised sense of agency tasks
sense of agency tasks will be tested using computer
Measured: one-month follow-up
EuroQol 5-Dimension 5-Level (EQ-5D-5L)
EuroQol 5-Dimension 5-Level (EQ-5D-5L), is the 5-digit code measuring functional ability. Each dimension in the EQ-5D-5L has five response levels: no problems (Level 1); slight; moderate; severe; and extreme problems (Level 5). There are 3,125 possible health states defined by combining one level from each dimension, ranging from 11111 (full health) to 55555 (worst health). A lower score means a better outcome.
Measured: immediately before treatment 1
EuroQol 5-Dimension 5-Level (EQ-5D-5L)
EuroQol 5-Dimension 5-Level (EQ-5D-5L), is the 5-digit code measuring functional ability. Each dimension in the EQ-5D-5L has five response levels: no problems (Level 1); slight; moderate; severe; and extreme problems (Level 5). There are 3,125 possible health states defined by combining one level from each dimension, ranging from 11111 (full health) to 55555 (worst health). A lower score means a better outcome.
Measured: one-month follow-up
EuroQol 5-Dimension 5-Level (EQ-5D-5L)
EuroQol 5-Dimension 5-Level (EQ-5D-5L), is the 5-digit code measuring functional ability. Each dimension in the EQ-5D-5L has five response levels: no problems (Level 1); slight; moderate; severe; and extreme problems (Level 5). There are 3,125 possible health states defined by combining one level from each dimension, ranging from 11111 (full health) to 55555 (worst health). A lower score means a better outcome.
Measured: three-month follow-up
36-item Short Form Health Survey (SF-36)
36-item Short Form Health Survey (SF-36) measured functional ability. It has a two-step interpretation. First, precoded numeric values are recoded per the scoring key. Each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100. A high score means a better outcome. In step 2, items in the same scale are averaged together to create the 8 scale scores.
Measured: immediately before treatment 1
36-item Short Form Health Survey (SF-36)
36-item Short Form Health Survey (SF-36) measured functional ability. It has a two-step interpretation. First, precoded numeric values are recoded per the scoring key. Each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100. A high score means a better outcome. In step 2, items in the same scale are averaged together to create the 8 scale scores.
Measured: one-month follow-up
36-item Short Form Health Survey (SF-36)
36-item Short Form Health Survey (SF-36) measured functional ability. It has a two-step interpretation. First, precoded numeric values are recoded per the scoring key. Each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100. A high score means a better outcome. In step 2, items in the same scale are averaged together to create the 8 scale scores.
Measured: three-month follow-up
Barthel Index
Barthel Index is a 10-item functional ability measure. An overall score is reached by adding the scores for each item and this ranges from 0 to 100. A higher score means a better outcome.
Measured: immediately before treatment 1
Barthel Index
Barthel Index is a 10-item functional ability measure. An overall score is reached by adding the scores for each item and this ranges from 0 to 100. A higher score means a better outcome.
Measured: one-month follow-up
Barthel Index
Barthel Index is a 10-item functional ability measure. An overall score is reached by adding the scores for each item and this ranges from 0 to 100. A higher score means a better outcome.
Measured: three-month follow-up
Change from Baseline Client Service Receipt Inventory
Client Service Receipt Inventory will be used for assessing participants' socio-economic conditions without any scores calculated. No minimum and maximum values.
Measured: three-month follow-up
Work and Social Adjustment Scale
Work and Social Adjustment Scale will be used to assess participants' socioeconomic conditions. Each item is rated on a 9-point scale from 0 (no impairment at all) to 8 (very severe impairment), so the total score is ranging from 0 to 40. Lower scores mean a better outcome.
Measured: immediately before treatment 1
Work and Social Adjustment Scale
Work and Social Adjustment Scale will be used to assess participants' socioeconomic conditions. Each item is rated on a 9-point scale from 0 (no impairment at all) to 8 (very severe impairment), so the total score is ranging from 0 to 40. Lower scores mean a better outcome.
Measured: one-month follow-up
Work and Social Adjustment Scale
Work and Social Adjustment Scale will be used to assess participants' socioeconomic conditions. Each item is rated on a 9-point scale from 0 (no impairment at all) to 8 (very severe impairment), so the total score is ranging from 0 to 40. Lower scores mean a better outcome.
Measured: three-month follow-up
Generalised Anxiety Disorder 7 (GAD-7)
Generalised Anxiety Disorder 7 (GAD-7) will be used for evaluating participants' psychological conditions; scores from 0 to 21, higher scores mean a worse outcome.
Measured: immediately before treatment 1
Generalised Anxiety Disorder 7 (GAD-7)
Generalised Anxiety Disorder 7 (GAD-7) will be used for evaluating participants' psychological conditions; scores from 0 to 21, higher scores mean a worse outcome.
Measured: one-month follow-up
Generalised Anxiety Disorder 7 (GAD-7)
Generalised Anxiety Disorder 7 (GAD-7) will be used for evaluating participants' psychological conditions; scores from 0 to 21, higher scores mean a worse outcome.
Measured: three-month follow-up
Patient Health Questionnaire 9 (PHQ9)
Patient Health Questionnaire 9 (PHQ9) will be used for evaluating participants' psychological conditions; scores from 0 to 27, higher scores mean a worse outcome.
Measured: immediately before treatment 1
Patient Health Questionnaire 9 (PHQ9)
Patient Health Questionnaire 9 (PHQ9) will be used for evaluating participants' psychological conditions; scores from 0 to 27, higher scores mean a worse outcome.
Measured: one-month follow-up
Patient Health Questionnaire 9 (PHQ9)
Patient Health Questionnaire 9 (PHQ9) will be used for evaluating participants' psychological conditions; scores from 0 to 27, higher scores mean a worse outcome.
Measured: three-month follow-up
Adapted Patient Health Questionnaire 15 (PHQ15)
Adapted Patient Health Questionnaire 15 (PHQ15) will be used for evaluating participants' psychological conditions; scores from 0 to 30, higher scores mean a worse outcome.
Measured: immediately before treatment 1
Adapted Patient Health Questionnaire 15 (PHQ15)
Adapted Patient Health Questionnaire 15 (PHQ15) will be used for evaluating participants' psychological conditions; scores from 0 to 30, higher scores mean a worse outcome.
Measured: one-month follow-up
Adapted Patient Health Questionnaire 15 (PHQ15)
Adapted Patient Health Questionnaire 15 (PHQ15) will be used for evaluating participants' psychological conditions; scores from 0 to 30, higher scores mean a worse outcome.
Measured: three-month follow-up
Multiscale Dissociation Inventory (MDI)
Multiscale Dissociation Inventory (MDI), a 30-item self-report test, evaluates participants' psychological conditions. It has a two-step interpretation. First, scoring each item using a scale ranging from 1 (never) to 5 (very often). In step 2, items in the same scale are summed together to create the 6 scale scores so the total score of each scale is from 5 to 25. A higher score means a worse outcome.
Measured: immediately before treatment 1
Multiscale Dissociation Inventory (MDI)
Multiscale Dissociation Inventory (MDI), a 30-item self-report test, evaluates participants' psychological conditions. It has a two-step interpretation. First, scoring each item using a scale ranging from 1 (never) to 5 (very often). In step 2, items in the same scale are summed together to create the 6 scale scores so the total score of each scale is from 5 to 25. A higher score means a worse outcome.
Measured: one-month follow-up
Multiscale Dissociation Inventory (MDI)
Multiscale Dissociation Inventory (MDI), a 30-item self-report test, evaluates participants' psychological conditions. It has a two-step interpretation. First, scoring each item using a scale ranging from 1 (never) to 5 (very often). In step 2, items in the same scale are summed together to create the 6 scale scores so the total score of each scale is from 5 to 25. A higher score means a worse outcome.
Measured: three-month follow-up
Emotion Regulation Questionnaire (ERQ)
Emotion Regulation Questionnaire (ERQ), a 10-item scale designed to measure respondents' tendency to regulate their emotions in two ways: Cognitive Reappraisal (items 1, 3, 5, 7, 8, 10) and Expressive Suppression (items 2, 4, 6, 9). Respondents answer each item on a 7-point Likert-type scale ranging from 1 (strongly disagree) to 7 (strongly agree). The scoring takes the average of all the scores ranging from 1 to 7. Higher scores mean better outcomes.
Measured: immediately before treatment 1
Emotion Regulation Questionnaire (ERQ)
Emotion Regulation Questionnaire (ERQ), a 10-item scale designed to measure respondents' tendency to regulate their emotions in two ways: Cognitive Reappraisal (items 1, 3, 5, 7, 8, 10) and Expressive Suppression (items 2, 4, 6, 9). Respondents answer each item on a 7-point Likert-type scale ranging from 1 (strongly disagree) to 7 (strongly agree). The scoring takes the average of all the scores ranging from 1 to 7. Higher scores mean better outcomes.
Measured: one-month follow-up
Emotion Regulation Questionnaire (ERQ)
Emotion Regulation Questionnaire (ERQ), a 10-item scale designed to measure respondents' tendency to regulate their emotions in two ways: Cognitive Reappraisal (items 1, 3, 5, 7, 8, 10) and Expressive Suppression (items 2, 4, 6, 9). Respondents answer each item on a 7-point Likert-type scale ranging from 1 (strongly disagree) to 7 (strongly agree). The scoring takes the average of all the scores ranging from 1 to 7. Higher scores mean better outcomes.
Measured: three-month follow-up
Multidimensional Assessment of Interoceptive Awareness, version 2 (MAIA-2)
Multidimensional Assessment of Interoceptive Awareness, version 2 (MAIA-2) is a self-report questionnaire with 37 items to measure interoception. It has a two-step interpretation. First, scoring each item on a six-point Likert scale from 0 (never) to 5 (always). In step 2, items in the same scale are averaged together to create the 8 scale scores. So the minimum score is 0 and the maximum score is 5. Higher scores mean a better outcome.
Measured: immediately before treatment 1
Multidimensional Assessment of Interoceptive Awareness, version 2 (MAIA-2)
Multidimensional Assessment of Interoceptive Awareness, version 2 (MAIA-2) is a self-report questionnaire with 37 items to measure interoception. It has a two-step interpretation. First, scoring each item on a six-point Likert scale from 0 (never) to 5 (always). In step 2, items in the same scale are averaged together to create the 8 scale scores. So the minimum score is 0 and the maximum score is 5. Higher scores mean a better outcome.
Measured: one-month follow-up
Multidimensional Assessment of Interoceptive Awareness, version 2 (MAIA-2)
Multidimensional Assessment of Interoceptive Awareness, version 2 (MAIA-2) is a self-report questionnaire with 37 items to measure interoception. It has a two-step interpretation. First, scoring each item on a six-point Likert scale from 0 (never) to 5 (always). In step 2, items in the same scale are averaged together to create the 8 scale scores. So the minimum score is 0 and the maximum score is 5. Higher scores mean a better outcome.
Measured: three-month follow-up
Sense of Agency Scale (SoAS)
Sense of Agency scale (SoAS), a 13-item scale designed to measure respondents' sense of agency in two ways: Sense of Positive Agency (SoPA) and Sense of Negative Agency (SoNA). Respondents answer each item on a 7-point Likert-type scale ranging from 1 (totally disagree) to 7 (fully agree). The scoring takes the sum of all the scores so the minimum scores are 6 (SoPA) or 7 (SoNA) and the maximum scores are 42 (SoPA) or 49 (SoNA). Higher scores mean better outcomes.
Measured: immediately before treatment 1
Sense of Agency Scale (SoAS)
Sense of Agency scale (SoAS), a 13-item scale designed to measure respondents' sense of agency in two ways: Sense of Positive Agency (SoPA) and Sense of Negative Agency (SoNA). Respondents answer each item on a 7-point Likert-type scale ranging from 1 (totally disagree) to 7 (fully agree). The scoring takes the sum of all the scores so the minimum scores are 6 (SoPA) or 7 (SoNA) and the maximum scores are 42 (SoPA) or 49 (SoNA). Higher scores mean better outcomes.
Measured: one-month follow-up
Sense of Agency Scale (SoAS)
Sense of Agency scale (SoAS), a 13-item scale designed to measure respondents' sense of agency in two ways: Sense of Positive Agency (SoPA) and Sense of Negative Agency (SoNA). Respondents answer each item on a 7-point Likert-type scale ranging from 1 (totally disagree) to 7 (fully agree). The scoring takes the sum of all the scores so the minimum scores are 6 (SoPA) or 7 (SoNA) and the maximum scores are 42 (SoPA) or 49 (SoNA). Higher scores mean better outcomes.
Measured: three-month follow-up
Pittsburgh Sleep Quality Index (PSQI)
Pittsburgh Sleep Quality Index (PSQI) will be used for assessing participants' sleep quality; scores from 0 to 21, higher scores mean a worse outcome.
Measured: immediately before treatment 1
Pittsburgh Sleep Quality Index (PSQI)
Pittsburgh Sleep Quality Index (PSQI) will be used for assessing participants' sleep quality; scores from 0 to 21, higher scores mean a worse outcome.
Measured: immediately before treatment 2
Pittsburgh Sleep Quality Index (PSQI)
Pittsburgh Sleep Quality Index (PSQI) will be used for assessing participants' sleep quality; scores from 0 to 21, higher scores mean a worse outcome.
Measured: one-month follow-up
Pittsburgh Sleep Quality Index (PSQI)
Pittsburgh Sleep Quality Index (PSQI) will be used for assessing participants' sleep quality; scores from 0 to 21, higher scores mean a worse outcome.
Measured: three-month follow-up
Salivary cortisol
Salivary cortisol will be measured to assess participants' stress
Measured: immediately before treatment 1
Salivary cortisol
Salivary cortisol will be measured to assess participants' stress
Measured: immediately before treatment 2
Salivary cortisol
Salivary cortisol will be measured to assess participants' stress
Measured: one-month follow-up
Actigraphy
Actigraphy-derived level of activity will be analysed to measure participants' activities. It reports parameters of activities such as time, frequency.
Measured: baseline
Actigraphy
Actigraphy-derived level of activity will be analysed to measure participants' activities. It reports parameters of activities such as time, frequency.
Measured: immediately after treatment 1
Actigraphy
Actigraphy-derived level of activity will be analysed to measure participants' activities. It reports parameters of activities such as time, frequency.
Measured: immediately before treatment 2
Adverse events (AE)
Adverse events details will be recorded
Measured: immediately before treatment 1
Adverse events (AE)
Adverse events details will be recorded
Measured: immediately after treatment 1
Adverse events (AE)
Adverse events details will be recorded
Measured: immediately before treatment 2
Adverse events (AE)
Adverse events details will be recorded
Measured: immediately after treatment 2
Adverse events (AE)
Adverse events details will be recorded
Measured: one-month follow-up
Adverse events (AE)
Adverse events details will be recorded
Measured: three-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2023
- Study start1 Aug 2023
- Primary completion30 Sep 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Functional Neurological Symptom DisorderStudies of the same condition, open and under way.
- More trials run by King's College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multi-centre, two-arm (active TMS, inactive TMS), double-blind (outcome assessor, patient), parallel-group RCT. Patients and researchers rating outcomes will be blind to the treatment arm, but it is not possible to blind the (different) researcher who is administering the treatments. There will be two treatment sessions, between 4-20 days apart, and two follow-up assessments one and three months after the first treatment session.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Collaborators
- South London and Maudsley NHS Foundation Trust, King's College Hospital NHS Trust
- Responsible party
- Sponsor
- Investigators
- Timothy Nicholson, MBBS, PhD, Principal investigator, King's College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05829005
- Sponsor's protocol ID
- 250915
- Acronym
- TONICS
- Status last verified
- Jan 2026
- First submitted
- 16 Jan 2023
- Last updated
- 2 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Personally identifiable or sensitive individual participant data will not be shared to protect the participants' confidentiality.
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trial of Neurostimulation Treatment and Investigation for Causes of Functional Motor Symptoms: a Pilot Study
- ClinicalTrials.gov ID
- NCT05829005
- Acronym / sponsor ID
- TONICS / 250915
- Conditions
- Functional Neurological Symptom Disorder
- Keywords
- Functional neurological disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Collaborators
- South London and Maudsley NHS Foundation Trust, King's College Hospital NHS Trust
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 30 Sep 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 25 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A pilot randomised controlled trial (RCT) of single-pulse transcranial magnetic stimulation (TMS) over the motor cortex to investigate efficacy in improving motor FND symptoms and to make a preliminary investigation of predictors of response to TMS and potential mechanisms of action.
Detailed description
This study is a pilot trial that will aim to determine if Transcranial Magnetic Stimulation (TMS) is an effective, tolerated and safe treatment for functional neurological disorder (FND) and to make a preliminary investigation of predictors of response to TMS and potential mechanisms of action.
This trial will be a 'randomised, two-arm, double-blind, parallel-arm study design. Randomised means that patients will be allocated to 'active' or 'inactive' treatment groups at random - this is done to minimise the chances of the characteristics of groups being different and influencing response to the different treatments. Double-blind means that the patients will not know which group they have been allocated to, and the assessors of response to treatment will be blinded, which will help reduce researcher 'bias' in assessing response. Parallel means that the treatment groups will occur alongside each other and patients will only have one of the treatments during the trial - unlike a 'crossover' design where patients will get both. However, after the trial, if a patient has received the 'inactive' treatment they will be offered the 'active' treatment if, after review by the clinician, such treatment is considered appropriate by the clinician.
The 'active' intervention is supra-threshold TMS that is so-called as it above the threshold needed to stimulate the primary motor cortex, the area of the brain known as 'M1' that when stimulated leads to contraction of limb muscles and can therefore make a weak limb move that the patient would otherwise not be able to move. This study postulates that it is the stimulation of a paralysed limb resulting in movement that is the active component of treatment, as it allows patients to relearn and re-experience normal movement, as well as providing proof of the possibility of the return of function.
An 'inactive' control arm is being used in this study as this is the standard way to show if, and how much, any response to the 'active' intervention might be due to chance. The investigators will be using sub-threshold TMS, so real TMS that will stimulate the motor cortex. This is different to other options for the control arm, such 'sham' TMS where no actual TMS pulse is delivered. Such sham devices deliver a similar sensation to the scalp and are designed to look the same as 'real' TMS devices so it is hard, and ideally impossible, for the patient to know whether they were getting real or sham treatment. This will also be delivered to the same location (primary motor cortex, ie. 'M1'). The location and number of pulses have been set at the same as the active treatment. The intensity of stimulation will necessarily be less, but will still result in a stimulus that is felt by the subject to maximise chances of successful blinding.
Importantly, and necessarily, details of what the two arms will involve are kept vague in the information sheet to maximise the chances of successful blinding of participants. There is genuine equipoise between these two proposed arms because, as yet, there is no evidence that the reported effects of TMS in the published case series are anything other than placebo. The one published feasibility RCT found no significant increase in subjective ratings of strength compared to placebo.
The use of blinded assessments of some clinician-rated measures and use of patient-rated outcomes (including the primary outcome measure) will reduce "researcher effects" and "researcher bias", as will use of the local (KCL) clinical trials unit (CTU) database system. During the trial, any changes in other treatments will be carefully documented at the start of treatment and at all subsequent assessments. No attempt will be made to standardise these or balance them between the arms other than randomisation but the effects of these, and other pertinent changes (e.g. other clinical parameters such as anxiety and depression scores) to see if they mediate outcomes.
Timetable
The research project will take approximately 12 months to complete after ethical approval. The investigators aim to randomise 60 patients to one of the treatment arms. The investigators anticipate being able to recruit at a rate of approximately 3 per week, therefore taking 20 weeks (5 months) to complete recruitment. This can be rounded up to 7 months to allow for slow initial recruitment whilst recruitment pathways are set up and for possible initial delays in starting first patients due to arranging mutually convenient times for consenting, assessing and first treatment session. Each patient will then take 5 months to complete the study, so the last patients will finish follow up 12 months after the first patient is recruited. There are no planned interim analyses/reports.
Study details
Recruitment
This will be from inpatient and outpatient settings in London.
The neuropsychiatry services of King's Health Partners (KHP). KHP is an Academic Health Sciences Centre comprising the National Health Service (NHS) Foundation Trusts associated with King's College London (KCL) directly serving 2 million patients in South East London. KHP has two regional neurosciences centres at King's College Hospital (KCH) and St.Thomas'/Guys Hospitals NHS foundation trusts. They will also be recruited from South West London \& St George's Mental Health NHS Trust (SWLSTG) and University College London Hospitals NHS Foundation Trust (UCLH). The South London and Maudsley NHS Foundation Trust (SLaM) is the UK's largest Mental Health Trust. All 3 trusts receive many FND referrals from the local population but also from the South East of England and beyond. Assessments will be in private rooms at the relevant hospitals or the Institute of Psychiatry, Psychology and Neuroscience (IoPPN - a faculty of KCL at the Denmark Hill campus next to KCH and Maudsley Hospitals). TMS treatments will be in specialist treatment rooms either at KCH (department of neurophysiology) or IoPPN (department of psychosis studies).
Suitable patients will be identified by the clinical team involved in their care who will inform them about the study and either give them directly (in the clinic or on the ward) or send them by post, the information sheet about the study and invite them to get in touch with a member of the research team as detailed in the information sheet. If the patient is seen face-to-face by the clinician they will ask if the patient is willing for their details to be passed on to the research team so they can contact them directly by their preferred method of contact (post, phone or email). If the patient is sent an information sheet they will be told they will receive a phone call following up the letter within 2 weeks of receiving it to enquire as to whether they are interested in taking part, with reassurance that there will be no further contact from the research team if they do not wish to find out more about the study which they can convey to the research team when called on the phone (or do beforehand by contacting the research team via mail, email or phone)
60 patients are widely considered a standard sample for such a pilot study.
Patient visits, assessments and treatments:
The full project protocol (attached to this application), and later sections of this form, give full details of the timing of visits/participants' potential flow through the study, assessment forms/measures and the technical specifications of the treatments.
In summary, 60 patients will undergo a maximum of 5 visits to the Denmark Hill campus (with an approximate length of time of visit):
Visit A - for Screening +/- consent (15 minutes) Visit B - for Consent (if not already done) / Baseline assessments (2 hours) Visit C - for 1st Treatment session + pre \& post-treatment assessments (2 hours) Visit D - for 2nd Treatment session + pre \& post-treatment assessments (2 hours) Visit E - for 1st (interim) follow up for outcome assessment (1-2 hours) Visit F - for 2nd (final) follow up assessment (1-2 hours)
Visit A could be conducted by phone (and consent delayed to visit B) or combined with visit B to suit patient preference and the circumstances of recruitment. Visits E and F could be carried out as home visits or by telephone as required.
The start of treatment (visit C) will be a maximum of 2 weeks after Baseline assessments (visit B) and randomisation will take place immediately before the first treatment session. The 2nd treatment (visit D) is between 4-20 days after the 1st treatment (visit C). The follow-up assessments (visits D and E) are 1 and 3 months after the 1st treatment session (visit C).
Some assessments, such as those covering fixed characteristics (e.g. demographics) or historical details (e.g. medical, psychiatric and treatment history) will be performed only once at baseline. Other assessments such as symptoms and other changeable characteristics will be performed serially. See protocol for full details.
Both treatment arms involved delivering 120 singles pules of TMS with a circular coil to the motor cortex (M1), the first 100 of which will be used to determine motor threshold (MT) but not generate twitch of any muscle that can be seen or felt by the patient. For the active arm, the final 20 pulses will be 'supra-motor threshold' (120% of MT) in that they will cause a palpable contraction of the muscles and a visible movement of the weak limb that is confirmed by the patient. For the inactive arm, these final 20 pulses will be a 'sub-motor threshold' (80% of MT) that won't cause a palpable or visible contraction of the weak limb. No specific suggestion of recovery will be used in either arm beyond that inherent in a trial of a novel therapy - i.e. no 'enhancement' of the placebo effect will be utilised.
At the end of the final follow up patients will be unblinded and a full debrief will be given by the PI. If they were in the inactive treatment arm the possibility of receiving sessions of active treatment will be discussed with them - and if the patient and the clinician both agree this indicated it will then be offered to the patient.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Multi-centre, two-arm (active TMS, inactive TMS), double-blind (outcome assessor, patient), parallel-group RCT. Patients and researchers rating outcomes will be blind to the treatment arm, but it is not possible to blind the (different) researcher who is administering the treatments. There will be two treatment sessions, between 4-20 days apart, and two follow-up assessments one and three months after the first treatment session.
| Arm | Type | Receives |
|---|---|---|
| Active arm | Active comparator | Device: Transcranial magnetic stimulation (TMS)The location and number of pulses will be set. The intensity of stimulation will be felt by the subject. 120 stimuli - including at least 20 supra (motor) threshold stimuli causing movement of the affected limb. |
| Inactive/control arm | Sham comparator | Device: Transcranial magnetic stimulation (TMS)The location and number of pulses have been set at the same as the active treatment. The intensity of stimulation will necessarily be less but will still result in a stimulus that is felt by the subject to maximise chances of successful blinding. 120 stimuli - no stimuli of sufficient intensity to produce movement. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) diagnosis of motor FND (i.e. presenting with weakness of at least one limb) made by consultant neurologist and/or neuropsychiatrist.
- Age ≥18yrs.
- Ability to give written informed consent.
Key exclusion criteria (10 listed)
- Epilepsy (or considered high risk of epilepsy from medical history).
- Other contraindication to TMS (e.g. cochlear implants, metallic intracranial clips/surgery in last 12 months).
- Comorbid organic neurological condition.
- Pain as primary symptom.
- Previous treatment with TMS (for any condition).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcranial magnetic stimulation (TMS)TMS is a form of 'non-invasive brain stimulation', i.e. it is a way of stimulating the brain from outside the head. It works by holding a magnetic coil approximately the size of a small side plate against the head (it rests on the scalp) which then delivers magnetic pulses that stimulate the underlying brain. It was developed over 30 years ago and has been increasingly used to treat a number of neurological and psychiatric disorders. It is considered a relatively safe and generally well-tolerated treatment. | Device | Active arm, Inactive/control arm |
Primary outcome
Adapted Patient Clinical Global Impression of Improvement (CGI-I) scale
Time frame: immediately before treatment 1
Adapted Patient Clinical Global Impression of Improvement (CGI-I) scale rated by the patient is a 7-point scale of improvement from 'very much improved' to 'very much worse'. 'Very much improved' means a better outcome.
Adapted Patient Clinical Global Impression of Improvement (CGI-I) scale
Time frame: immediately after treatment 1
Adapted Patient Clinical Global Impression of Improvement (CGI-I) scale rated by the patient is a 7-point scale of improvement from 'very much improved' to 'very much worse'. 'Very much improved' means a better outcome.
Adapted Patient Clinical Global Impression of Improvement (CGI-I) scale
Time frame: immediately before treatment 2
Adapted Patient Clinical Global Impression of Improvement (CGI-I) scale rated by the patient is a 7-point scale of improvement from 'very much improved' to 'very much worse'. 'Very much improved' means a better outcome.
Adapted Patient Clinical Global Impression of Improvement (CGI-I) scale
Time frame: immediately after treatment 2
Adapted Patient Clinical Global Impression of Improvement (CGI-I) scale rated by the patient is a 7-point scale of improvement from 'very much improved' to 'very much worse'. 'Very much improved' means a better outcome.
Adapted Patient Clinical Global Impression of Improvement (CGI-I) scale
Time frame: one-month follow-up
Adapted Patient Clinical Global Impression of Improvement (CGI-I) scale rated by the patient is a 7-point scale of improvement from 'very much improved' to 'very much worse'. 'Very much improved' means a better outcome.
Adapted Patient Clinical Global Impression of Improvement (CGI-I) scale
Time frame: three-month follow-up
Adapted Patient Clinical Global Impression of Improvement (CGI-I) scale rated by the patient is a 7-point scale of improvement from 'very much improved' to 'very much worse'. 'Very much improved' means a better outcome.
76 secondary outcomes
Adapted Outcome Assessor Clinical Global Impression of Improvement (CGI-I) scale
Time frame: immediately before treatment 1
Adapted Outcome Assessor Clinical Global Impression of Improvement (CGI-I) scale
Time frame: immediately after treatment 1
Adapted Outcome Assessor Clinical Global Impression of Improvement (CGI-I) scale
Time frame: immediately before treatment 2
Adapted Outcome Assessor Clinical Global Impression of Improvement (CGI-I) scale
Time frame: immediately after treatment 2
Adapted Outcome Assessor Clinical Global Impression of Improvement (CGI-I) scale
Time frame: one-month follow-up
Adapted Outcome Assessor Clinical Global Impression of Improvement (CGI-I) scale
Time frame: three-month follow-up
Adapted Carer Clinical Global Impression of Improvement (CGI-I) scale
Time frame: immediately before treatment 1
Adapted Carer Clinical Global Impression of Improvement (CGI-I) scale
Time frame: immediately after treatment 1
Adapted Carer Clinical Global Impression of Improvement (CGI-I) scale
Time frame: immediately before treatment 2
Adapted Carer Clinical Global Impression of Improvement (CGI-I) scale
Time frame: immediately after treatment 2
Adapted Carer Clinical Global Impression of Improvement (CGI-I) scale
Time frame: one-month follow-up
Adapted Carer Clinical Global Impression of Improvement (CGI-I) scale
Time frame: three-month follow-up
Strength patient ratings
Time frame: immediately before treatment 1
Strength patient ratings
Time frame: immediately after treatment 1
Strength patient ratings
Time frame: immediately before treatment 2
Strength patient ratings
Time frame: immediately after treatment 2
Strength patient ratings
Time frame: one-month follow-up
Strength patient ratings
Time frame: three-month follow-up
Dynamometer
Time frame: immediately before treatment 1
Dynamometer
Time frame: immediately after treatment 1
Dynamometer
Time frame: immediately before treatment 2
Dynamometer
Time frame: immediately after treatment 2
Dynamometer
Time frame: one-month follow-up
Dynamometer
Time frame: three-month follow-up
Change from baseline computerised attention tasks
Time frame: one-month follow-up
Change from baseline computerised sense of agency tasks
Time frame: one-month follow-up
EuroQol 5-Dimension 5-Level (EQ-5D-5L)
Time frame: immediately before treatment 1
EuroQol 5-Dimension 5-Level (EQ-5D-5L)
Time frame: one-month follow-up
EuroQol 5-Dimension 5-Level (EQ-5D-5L)
Time frame: three-month follow-up
36-item Short Form Health Survey (SF-36)
Time frame: immediately before treatment 1
36-item Short Form Health Survey (SF-36)
Time frame: one-month follow-up
36-item Short Form Health Survey (SF-36)
Time frame: three-month follow-up
Barthel Index
Time frame: immediately before treatment 1
Barthel Index
Time frame: one-month follow-up
Barthel Index
Time frame: three-month follow-up
Change from Baseline Client Service Receipt Inventory
Time frame: three-month follow-up
Work and Social Adjustment Scale
Time frame: immediately before treatment 1
Work and Social Adjustment Scale
Time frame: one-month follow-up
Work and Social Adjustment Scale
Time frame: three-month follow-up
Generalised Anxiety Disorder 7 (GAD-7)
Time frame: immediately before treatment 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2026.
- Individual participant dataSharing planned: No. Personally identifiable or sensitive individual participant data will not be shared to protect the participants' confidentiality.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Timothy Nicholson, MBBS, PhD principal investigator
King's College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial magnetic stimulation (TMS) in people with Functional Neurological Symptom Disorder, run by King's College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adapted Patient Clinical Global Impression of Improvement (CGI-I) scale (time frame: immediately before treatment 1). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2026.