Functional Neurological DisordersNCT02905877
The Pathophysiology of Functional Neurological Disorders
An observational study of Functional Neurological Disorders, run by University College, London at 1 site in United Kingdom.
Trial summary
Functional disorders, also called psychogenic or psychosomatic are very common, disabling and their costs to society are immense. Functional movement disorders are abnormal, involuntary movements, that are illogical in terms of classic neurology. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Functional Neurological Disorders
- What is being tested?
- Behavioural study
- How many people
- 130 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2016to 30 Sep 2019
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: see below under inclusion criteria
Who may be able to join
- We will recruit three groups of participants:
- functional neurological disorders, e.g. functional tremor: diagnosed by a neurologist.
- organic counterpart of the functional neurological disorders, e.g. in the case of functional tremor, the organic counterpart would be organic tremor: presence of an organic tremor according to internationally recognised guidelines and diagnosed by a neurologist.
- healthy age-matched controls.
Who cannot join
- Healthy Participants: Major neurological disorder.
- All groups:
- Age under 18 or over 80
- Significant impairment in ability to give informed consent for study procedures due to significant cognitive impairment and/or inability to understand study literature,
- very severe tremor
- moderate or severe cognitive impairment
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Institute of Neurology, University College London
London, WC1N 3BG
About this study
Functional disorders, also called psychogenic or psychosomatic are very common, disabling and their costs to society are immense.
Functional movement disorders are abnormal, involuntary movements, that are illogical in terms of classic neurology. Intriguingly, they typically manifest when patients pay attention to them and disappear with distraction.
Read more
The investigators aim to further the understanding of the pathophysiological mechanisms underlying functional neurological disorders in order to improve treatment. In particular they aim to understand the effect of attention on movement in general, on functional neurological mechanisms and on the sense of agency (of subjective control) over a movement.
Patients with a functional neurological disorder, patients with an organic neurological disorder and healthy participants will perform simple tasks, such as reaching to a target, while additional tasks will manipulate their attention. The effects of these attentional manipulations will be analysed on several levels: movement performance, analysed by the kinematics and electromyography (EMG),and psychophysical measures, such as the sense of agency.
If the hypothesis turns out to be true, then changing the attentional focus could be used as a treatment in functional neurological disorders.
- Conditions
- Functional Neurological Disorders
- Being tested
- Behavioural study
- Medical subject headings
- Conversion Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioural studyOther
reaching studies and other behavioural studies.
| Study group | Role | What they receive |
|---|---|---|
| Functional neurological disorders | Initially especially patients diagnosed with a functional tremor. Receives: Other: Behavioural study | |
| Organic neurological disorders. | Initially especially patients diagnosed with a an organic action tremor (e.g. essential tremor or dystonic tremor). Receives: Other: Behavioural study | |
| Healthy control | Healthy age matched controls Receives: Other: Behavioural study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tremor severity, assessed by kinematics, under different attentional conditions
Measured: 1 year
Secondary outcomes (1)
Sense of agency, assessed by intentional binding, under different attentional conditions
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2016 (estimated)
- Study startSep 2016
- Primary completion30 Sep 2019
- Study completion30 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Functional Neurological DisordersStudies of the same condition, open and under way.
- More trials run by University 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
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02905877
- Sponsor's protocol ID
- 16/0275
- Status last verified
- Mar 2020
- First submitted
- 2 Sep 2016
- Last updated
- 27 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Pathophysiology of Functional Neurological Disorders
- ClinicalTrials.gov ID
- NCT02905877
- Acronym / sponsor ID
- 16/0275
- Conditions
- Functional Neurological Disorders
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Study start
- Sep 2016 (actual)
- Primary completion
- 30 Sep 2019 (actual)
- Study completion
- 30 Sep 2019 (actual)
- First posted
- 19 Sep 2016 (estimated)
- 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.
Functional disorders, also called psychogenic or psychosomatic are very common, disabling and their costs to society are immense.
Functional movement disorders are abnormal, involuntary movements, that are illogical in terms of classic neurology. Intriguingly, they typically manifest when patients pay attention to them and disappear with distraction.
The investigators aim to further the understanding of the pathophysiological mechanisms underlying functional neurological disorders in order to improve treatment. In particular they aim to understand the effect of attention on movement in general, on functional neurological mechanisms and on the sense of agency (of subjective control) over a movement.
Patients with a functional neurological disorder, patients with an organic neurological disorder and healthy participants will perform simple tasks, such as reaching to a target, while additional tasks will manipulate their attention. The effects of these attentional manipulations will be analysed on several levels: movement performance, analysed by the kinematics and electromyography (EMG),and psychophysical measures, such as the sense of agency.
If the hypothesis turns out to be true, then changing the attentional focus could be used as a treatment in functional neurological disorders.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Functional neurological disorders | – | Other: Behavioural studyInitially especially patients diagnosed with a functional tremor. |
| Organic neurological disorders. | – | Other: Behavioural studyInitially especially patients diagnosed with a an organic action tremor (e.g. essential tremor or dystonic tremor). |
| Healthy control | – | Other: Behavioural studyHealthy age matched controls |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- see below under inclusion criteria
Key inclusion criteria (4 listed)
- We will recruit three groups of participants:
Key exclusion criteria (6 listed)
- Healthy Participants: Major neurological disorder.
- Age under 18 or over 80
- Significant impairment in ability to give informed consent for study procedures due to significant cognitive impairment and/or inability to understand study literature,
- very severe tremor
- moderate or severe cognitive impairment
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 |
|---|---|---|
| Behavioural studyreaching studies and other behavioural studies. | Other | Functional neurological disorders, Healthy control, Organic neurological disorders. |
Primary outcome
Tremor severity, assessed by kinematics, under different attentional conditions
Time frame: 1 year
1 secondary outcome
Sense of agency, assessed by intentional binding, under different attentional conditions
Time frame: 1 year
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 27 Mar 2020.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Functional Neurological Disorders, run by University 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 4 inclusion and 6 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 27 Mar 2020. 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. 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?
Tremor severity, assessed by kinematics, under different attentional conditions (time frame: 1 year). 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 27 Mar 2020.