Psychogenic Nonepileptic SeizuresADIE-FSNCT06105996
ADIE-FS - Aligning Dimensions of Interoceptive Experience in Patients With Functional Seizures
A study testing Interoceptive training in people with Psychogenic Nonepileptic Seizures and Dissociative Seizures, run by University College, London at 1 site in United Kingdom.
Trial summary
Functional seizures are common and harmful. They look like epileptic seizures but are not caused by the excess electrical discharges in the brain that arise in epilepsy. Our understanding of the mechanisms that give rise to functional seizures is limited, and for this reason the development of novel treatments for… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psychogenic Nonepileptic Seizures, Dissociative Seizures, Psychogenic Pseudoseizure
- What is being tested?
- Interoceptive training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 10 Jan 2024to 1 May 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged over 18 years
- Capacity to complete informed consent to take part in study
- Possible, or probable or clinically established or documented functional seizure as per International League Against Epilepsy (ILAE) criteria
Who cannot join
- Age below 18 years
- Past moderate to severe head injury as defined by Mayo criteria
- Moderate to severe cognitive impairment
- Co-existing or past neurological disorder causing sensorimotor symptoms
- Co-existing major psychiatric disorder with active psychosis
- Moderate to severe musculo-skeletal disease (e.g., osteoarthritis or rheumatoid arthritis) causing functional impairment (e.g., in gait or basic activities of daily living)
Show all 14Show fewer
- Current substance or alcohol dependence
- A recent cardiovascular event (last 12 months) or undiagnosed chest pain
- BMI (body mass index > 40kg/m2)
- Taking cardiac ionotropic drugs
- Uncontrolled hypertension
- Pregnancy
- Uncontrolled asthma or COPD (chronic obstructive pulmonary disease)
- Are having cognitive behavioural therapy (CBT) specifically for functional seizures, or are due to have CBT specifically for functional seizures within the period of the study.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Queen Square Institute of Neurology
London, WC1N 3BG
Mahinda Yogarajah, MRCP PHD, 01494 601369, m.yogarajah@ucl.ac.uk
About this study
Functional seizures are common and harmful. They look like epileptic seizures but are not caused by the excess electrical discharges in the brain that arise in epilepsy. Our understanding of the mechanisms that give rise to functional seizures is limited, and for this reason the development of novel treatments for functional seizures is also limited. Recent research by our and other groups has shown that interoception may play an important role in the development of functional seizures. Interoception refers to the process by which the nervous system senses, interprets and integrates information from inside the body. Research has shown that altered interoception is linked to functional seizures. We have shown that patients with functional seizures have a reduced ability to accurately identify signals from within their bodies, such as their heartbeats. The worse their ability, the greater their seizure severity and higher their levels of other unwanted symptoms. In separate research other groups have shown that interoceptive training, that is actively training an individual to better recognise signals from their body, can reduce levels of anxiety and the levels of unwanted symptoms. In this study we therefore plan to explore the feasibility of interoceptive training in patients with functional seizures.
Read the detailed description
Functional seizures are common and harmful. They look like epileptic seizures but are not caused by the excess electrical discharges in the brain that arise in epilepsy. Recent research by our and other groups has shown that interoception may play an important role in the development of functional seizures. Interoception refers to the process by which the nervous system senses, interprets and integrates information from inside the body. Research using heartbeat recognition tests has shown that persons with functional seizures have a reduced ability to accurately read out signals originating from within their body, and that this corresponds with seizure frequency and other symptomatology. Separate research has shown that actively training an individual interoceptively using cardiac interoceptive tasks can reduce anxiety levels and somatic symptoms.
The primary objective of this study is to demonstrate the feasibility of an interoceptive therapy program to reduce functional seizure severity and/or duration for patients. The secondary objective is to ascertain if the interoceptive therapy program leads to an improvement in interoceptive measurements, health-related quality of life, exercise, psychosocial functioning, psychiatric symptoms, psychological distress, and somatic symptom benefit for patients.
This is an open label, feasibility and pilot study. There will be two arms, an intervention arm and a treatment as usual arm. We aim to recruit 10 participants in each arm (n=20 in total).
Participants with functional seizures will be recruited from UCLH (University College London Hospitals) neurology services. At an initial face-to-face meeting participants will sign the consent form and complete further questionnaires, in addition to those they have already completed at home. Participants will then be randomised to one of two groups, an intervention group and treatment as usual group. Participants in both groups will complete two cardiac interoceptive tasks at baseline. A schedule for the six interoceptive training sessions will then be agreed for those participants in the intervention group, and completed within two months. During each training session the participant will complete the cardiac interoceptive tasks with active feedback, before and after a 2 to 3 minute period of self-directed exercise whose purpose is to elevate the heartbeat. The purpose of the exercise is ultimately to increase cardiovascular arousal and accompanying sensations such that it is easier for them to perceive their heartbeat in the interoceptive tasks.
After the final training session, participants in both groups will complete the same set of questionnaires, and have one further face-to-face meeting, where they will complete the cardiac interoceptive tasks again. Participants in both groups will also be followed up at 3 months and repeat both the questionnaires and interoceptive testing.
- Conditions
- Psychogenic Nonepileptic Seizures, Dissociative Seizures, Psychogenic Pseudoseizure, Functional Neurological Disorder, Non Epileptic Seizure
- Being tested
- Interoceptive training
- Keywords
- interoception, functional seizures, functional neurological disorder
- Medical subject headings
- Psychogenic Nonepileptic Seizures, Conversion Disorder, Seizures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interoceptive trainingBehavioural
There will be 6 interoceptive training sessions carried out over two months. Each training session will comprise two blocks, between which participants will undergo a self-paced, light physical activity that aims to enhance heartbeat perception and lasts 2 to 3 minutes. During the pre- and post-exercise block, each participant will complete cardiac interoceptive tasks, and for each trial, note their confidence in their answer on a visual analogue scale and then be given accurate feedback about their objective heartbeat perception accuracy and the accuracy of their subjective confidence rating, relative to their objective accuracy.
| Study group | Role | What they receive |
|---|---|---|
| Interoceptive training | Experimental | Participants will undergo 6 sessions of cardiac interoceptive training. Receives: Behavioral: Interoceptive training |
| Treatment as usual arm | No intervention | Participants will undergo treatment as usual. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with functional seizures who are eligible for our pilot study who agree to be enrolled in intervention arm of ADIE-FS.
Feasibility measure
Measured: 24 months
Proportion of participants who complete the ADIE-FS programme of treatment.
Feasibility measure
Measured: 24 months
Proportion of participants with a 3-item Client Satisfaction Questionnaire (CSQ-3) score ≥ 9 for the ADIE-FS intervention (range of scores is 8 to 32 where higher scores indicate increased satisfaction).
Feasibility measure
Measured: 24 months
Proportion of participants taking part in intervention with a mean score on the Treatment Expectancy Questionnaire (TEQ) ≥ 50% for the ADIE-FS intervention (higher scores indicate greater expectancy that the intervention will be useful).
Feasibility measure
Measured: 24 months
Secondary outcomes (11)
Cardiac interoceptive accuracy scores
Changes in cardiac interoceptive accuracy scores from baseline to end of study will be calculated in both groups using behavioural tests. Higher scores will indicate greater objective interoceptive accuracy.
Measured: 24 months
Cardiac interoceptive sensibility scores
Changes in cardiac interoceptive sensibility scores from baseline to end of study will be calculated in both groups using the Porges body awareness questionnaire. Higher scores will indicate greater subjective perception of interoceptive accuracy.
Measured: 24 months
Cardiac interoceptive awareness scores
Changes in cardiac interoceptive awareness scores from baseline to end of study will be calculated in both groups. Higher scores will indicate lesser discrepancy between subjective and objective interoceptive accuracy.
Measured: 24 months
Seizure frequency and bothersomeness
Changes in seizure frequency and bothersomeness from baseline to the end of the study will be calculated in both groups using seizure diaries and a seizure severity scale. Higher scores will indicate greater seizure frequency and severity.
Measured: 24 months
Levels of physical activity.
Changes in levels of physical activity from baseline to the end of the study will be calculated in both groups using the International Physical Activity Questionnaire. Higher scores will indicate greater levels of physical activity.
Measured: 24 months
Levels of detachment dissociation.
Changes in levels of trait detachment dissociation from baseline to the end of the study will be calculated in both groups using the multiscale dissociation inventory. Higher scores indicate greater levels of dissociation.
Measured: 24 months
Levels of compartmentalisation dissociation.
Changes in levels of trait compartmentalisation dissociation from baseline to the end of the study will be calculated in both groups using the somatoform dissociation questionnaire. Higher scores indicate greater levels of dissociation.
Measured: 24 months
Levels of anxiety.
Changes in levels of trait anxiety from baseline to the end of the study will be calculated in both groups using the trait anxiety inventory. Higher scores indicate greater levels of anxiety.
Measured: 24 months
Levels of somatic symptoms.
Changes in levels of somatic symptoms from baseline to the end of the study will be calculated in both groups using the patient health questionnaire-15. Higher scores indicate greater levels of somatic symptoms.
Measured: 24 months
Quality of life metric.
Changes in quality of life from baseline to the end of the study will be calculated in both groups using the 12 item short form survey. Higher scores indicate poorer quality of life.
Measured: 24 months
Functional impairment.
Changes in functional impairment from baseline to the end of the study will be calculated in both groups using the work and social adjustment scale. Higher scores indicate greater functional impairment.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2023
- Study start10 Jan 2024
- Primary completion1 May 2024 (estimated)
- Study completion1 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Psychogenic Nonepileptic SeizuresStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants in the study will be randomised to the intervention group (interoceptive training) or the treatment as usual group.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Collaborators
- Columbia University
- Responsible party
- Sponsor
- Investigators
- Mahinda Yogarajah, PHD, Principal investigator, UCL/UCLH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06105996
- Sponsor's protocol ID
- 155563
- Other IDs
- 322599, 23/NS/0075
- Acronym
- ADIE-FS
- Status last verified
- Mar 2024
- First submitted
- 9 Oct 2023
- Last updated
- 4 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Koreki A, Garfkinel SN, Mula M, Agrawal N, Cope S, Eilon T, Gould Van Praag C, Critchley HD, Edwards M, Yogarajah M. Trait and state interoceptive abnormalities are associated with dissociation and seizure frequency in patients with functional seizures. Epilepsia. 2020 Jun;61(6):1156-1165. doi: 10.1111/epi.16532. Epub 2020 Jun 5.
PubMed 32501547Quadt L, Garfinkel SN, Mulcahy JS, Larsson DE, Silva M, Jones AM, Strauss C, Critchley HD. Interoceptive training to target anxiety in autistic adults (ADIE): A single-center, superiority randomized controlled trial. EClinicalMedicine. 2021 Aug 1;39:101042. doi: 10.1016/j.eclinm.2021.101042. eCollection 2021 Sep.
PubMed 34401684
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ADIE-FS - Aligning Dimensions of Interoceptive Experience in Patients With Functional Seizures
- ClinicalTrials.gov ID
- NCT06105996
- Acronym / sponsor ID
- ADIE-FS / 155563
- Conditions
- Psychogenic Nonepileptic Seizures, Dissociative Seizures, Psychogenic Pseudoseizure, Functional Neurological Disorder, Non Epileptic Seizure
- Keywords
- interoception, functional seizures, functional neurological disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Collaborators
- Columbia University
- Study start
- 10 Jan 2024 (actual)
- Primary completion
- 1 May 2024 (estimated)
- Study completion
- 1 May 2024 (estimated)
- First posted
- 30 Oct 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.
Functional seizures are common and harmful. They look like epileptic seizures but are not caused by the excess electrical discharges in the brain that arise in epilepsy. Our understanding of the mechanisms that give rise to functional seizures is limited, and for this reason the development of novel treatments for functional seizures is also limited. Recent research by our and other groups has shown that interoception may play an important role in the development of functional seizures. Interoception refers to the process by which the nervous system senses, interprets and integrates information from inside the body. Research has shown that altered interoception is linked to functional seizures. We have shown that patients with functional seizures have a reduced ability to accurately identify signals from within their bodies, such as their heartbeats. The worse their ability, the greater their seizure severity and higher their levels of other unwanted symptoms. In separate research other groups have shown that interoceptive training, that is actively training an individual to better recognise signals from their body, can reduce levels of anxiety and the levels of unwanted symptoms. In this study we therefore plan to explore the feasibility of interoceptive training in patients with functional seizures.
Detailed description
Functional seizures are common and harmful. They look like epileptic seizures but are not caused by the excess electrical discharges in the brain that arise in epilepsy. Recent research by our and other groups has shown that interoception may play an important role in the development of functional seizures. Interoception refers to the process by which the nervous system senses, interprets and integrates information from inside the body. Research using heartbeat recognition tests has shown that persons with functional seizures have a reduced ability to accurately read out signals originating from within their body, and that this corresponds with seizure frequency and other symptomatology. Separate research has shown that actively training an individual interoceptively using cardiac interoceptive tasks can reduce anxiety levels and somatic symptoms.
The primary objective of this study is to demonstrate the feasibility of an interoceptive therapy program to reduce functional seizure severity and/or duration for patients. The secondary objective is to ascertain if the interoceptive therapy program leads to an improvement in interoceptive measurements, health-related quality of life, exercise, psychosocial functioning, psychiatric symptoms, psychological distress, and somatic symptom benefit for patients.
This is an open label, feasibility and pilot study. There will be two arms, an intervention arm and a treatment as usual arm. We aim to recruit 10 participants in each arm (n=20 in total).
Participants with functional seizures will be recruited from UCLH (University College London Hospitals) neurology services. At an initial face-to-face meeting participants will sign the consent form and complete further questionnaires, in addition to those they have already completed at home. Participants will then be randomised to one of two groups, an intervention group and treatment as usual group. Participants in both groups will complete two cardiac interoceptive tasks at baseline. A schedule for the six interoceptive training sessions will then be agreed for those participants in the intervention group, and completed within two months. During each training session the participant will complete the cardiac interoceptive tasks with active feedback, before and after a 2 to 3 minute period of self-directed exercise whose purpose is to elevate the heartbeat. The purpose of the exercise is ultimately to increase cardiovascular arousal and accompanying sensations such that it is easier for them to perceive their heartbeat in the interoceptive tasks.
After the final training session, participants in both groups will complete the same set of questionnaires, and have one further face-to-face meeting, where they will complete the cardiac interoceptive tasks again. Participants in both groups will also be followed up at 3 months and repeat both the questionnaires and interoceptive testing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants in the study will be randomised to the intervention group (interoceptive training) or the treatment as usual group.
| Arm | Type | Receives |
|---|---|---|
| Interoceptive training | Experimental | Behavioral: Interoceptive trainingParticipants will undergo 6 sessions of cardiac interoceptive training. |
| Treatment as usual arm | No intervention | –Participants will undergo treatment as usual. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aged over 18 years
- Capacity to complete informed consent to take part in study
- Possible, or probable or clinically established or documented functional seizure as per International League Against Epilepsy (ILAE) criteria
Key exclusion criteria (14 listed)
- Age below 18 years
- Past moderate to severe head injury as defined by Mayo criteria
- Moderate to severe cognitive impairment
- Co-existing or past neurological disorder causing sensorimotor symptoms
- Co-existing major psychiatric disorder with active psychosis
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 |
|---|---|---|
| Interoceptive trainingThere will be 6 interoceptive training sessions carried out over two months. Each training session will comprise two blocks, between which participants will undergo a self-paced, light physical activity that aims to enhance heartbeat perception and lasts 2 to 3 minutes. During the pre- and post-exercise block, each participant will complete cardiac interoceptive tasks, and for each trial, note their confidence in their answer on a visual analogue scale and then be given accurate feedback about their objective heartbeat perception accuracy and the accuracy of their subjective confidence rating, relative to their objective accuracy. | Behavioural | Interoceptive training |
Primary outcome
Proportion of patients with functional seizures who are eligible for our pilot study who agree to be enrolled in intervention arm of ADIE-FS.
Time frame: 24 months
Feasibility measure
Proportion of participants who complete the ADIE-FS programme of treatment.
Time frame: 24 months
Feasibility measure
Proportion of participants with a 3-item Client Satisfaction Questionnaire (CSQ-3) score ≥ 9 for the ADIE-FS intervention (range of scores is 8 to 32 where higher scores indicate increased satisfaction).
Time frame: 24 months
Feasibility measure
Proportion of participants taking part in intervention with a mean score on the Treatment Expectancy Questionnaire (TEQ) ≥ 50% for the ADIE-FS intervention (higher scores indicate greater expectancy that the intervention will be useful).
Time frame: 24 months
Feasibility measure
11 secondary outcomes
Cardiac interoceptive accuracy scores
Time frame: 24 months
Cardiac interoceptive sensibility scores
Time frame: 24 months
Cardiac interoceptive awareness scores
Time frame: 24 months
Seizure frequency and bothersomeness
Time frame: 24 months
Levels of physical activity.
Time frame: 24 months
Levels of detachment dissociation.
Time frame: 24 months
Levels of compartmentalisation dissociation.
Time frame: 24 months
Levels of anxiety.
Time frame: 24 months
Levels of somatic symptoms.
Time frame: 24 months
Quality of life metric.
Time frame: 24 months
Functional impairment.
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2024.
- Results publication: PubMed 32501547Koreki A, Garfkinel SN, Mula M, Agrawal N, Cope S, Eilon T, Gould Van Praag C, Critchley HD, Edwards M, Yogarajah M. Trait and state interoceptive abnormalities are associated with dissociation and seizure frequency in patients with functional seizures. Epilepsia. 2020 Jun;61(6):1156-1165. doi: 10.1111/epi.16532. Epub 2020 Jun 5.
- Results publication: PubMed 34401684Quadt L, Garfinkel SN, Mulcahy JS, Larsson DE, Silva M, Jones AM, Strauss C, Critchley HD. Interoceptive training to target anxiety in autistic adults (ADIE): A single-center, superiority randomized controlled trial. EClinicalMedicine. 2021 Aug 1;39:101042. doi: 10.1016/j.eclinm.2021.101042. eCollection 2021 Sep.
- Individual participant dataSharing planned: No
Related trials for Psychogenic Nonepileptic Seizures
RecruitingEarly Phase 1
Accelerated TMS for Seizure-Type Functional Neurologic Disorders
Functional Neurological Symptom Disorder, Functional Seizures
Recruiting
Modulating Movement Intention Via Cortical Stimulation
Seizures, Seizure Disorder
Recruiting
Retraining and Control Therapy (ReACT): Sense of Control and Symptom Expectations as Targets of a Treatment for PNES
Convulsion, Non-Epileptic
RecruitingPhase 1/2
Effects of a Sigle Dose of Ayahuasca in Patients With Psychogenic Non-epileptic Seizures: an Open Label Clinical Trial
Non Epileptic Seizures
Active, not recruitingObservational study
Study on the Rapid Diagnostic Value of Sudden Clap Provocation Test in Psychogenic Nonepileptic Seizures
Epilepsy, Psychogenic Non-epileptic Seizures
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.
Mahinda Yogarajah, PHD principal investigator
UCL/UCLH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interoceptive training in people with Psychogenic Nonepileptic Seizures and Dissociative Seizures, 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 3 inclusion and 14 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: status not confirmed, as of the sponsor's last update on 4 Mar 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pushpsen Joshi, PHD (020 3447 5557, Uclh.randd@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with functional seizures who are eligible for our pilot study who agree to be enrolled in intervention arm of ADIE-FS. (time frame: 24 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06105996, which also lists 2 linked publications.
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 4 Mar 2024.