An interventional study of Interoceptive training in Psychogenic Nonepileptic Seizures, Dissociative Seizures and Psychogenic Pseudoseizure, sponsored by University College, London. Recruiting at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-03-04.
Sponsored by University College, London · Not applicable, Interventional, and Treatment
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.
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.
24 studies on the registry are indexed under Psychogenic Nonepileptic Seizures; 5 are open to participants now.
This study's planned enrollment of 20 is below the median of 41 across 20 interventional studies indexed under Psychogenic Nonepileptic Seizures.
Browse Psychogenic Nonepileptic Seizures studies →University College, London is the lead sponsor of 651 studies on the registry; 149 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 2 (33%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will undergo 6 sessions of cardiac interoceptive training.
Behavioral: Interoceptive training
Participants will undergo treatment as usual.
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.
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
Time frame: 24 months
Proportion of participants who complete the ADIE-FS programme of treatment.
Feasibility measure
Time frame: 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
Time frame: 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
Time frame: 24 months
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 24 months
Plan to share: No
Started Jan 2024 (actual). Primary completion is estimated for May 2024, 3 months after the start.
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