Clinical trial NCT06105996: ADIE-FS - Aligning Dimensions of Interoceptive Experience in Patients With Functional Seizures
Official title: ADIE-FS - Aligning Dimensions of Interoceptive Experience in Patients With Functional Seizures
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Psychogenic Nonepileptic Seizures
Dissociative Seizures
Psychogenic Pseudoseizure
Functional Neurological Disorder
Non Epileptic Seizure
Keywords: interoception
functional seizures
functional neurological disorder
Lead sponsor: University College, London
Sponsor class: OTHER
Collaborators: name: Columbia University
First posted: 2023-10-30
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants in the study will be randomised to the intervention group (interoceptive training) or the treatment as usual group.
Primary purpose: TREATMENT

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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)
* 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.

Primary outcomes:
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.
timeFrame: 24 months
measure: Proportion of participants who complete the ADIE-FS programme of treatment.
timeFrame: 24 months
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).
timeFrame: 24 months
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).
timeFrame: 24 months
Secondary outcomes:
measure: Cardiac interoceptive accuracy scores
timeFrame: 24 months
measure: Cardiac interoceptive sensibility scores
timeFrame: 24 months
measure: Cardiac interoceptive awareness scores
timeFrame: 24 months
measure: Seizure frequency and bothersomeness
timeFrame: 24 months
measure: Levels of physical activity.
timeFrame: 24 months
measure: Levels of detachment dissociation.
timeFrame: 24 months
measure: Levels of compartmentalisation dissociation.
timeFrame: 24 months
measure: Levels of anxiety.
timeFrame: 24 months
measure: Levels of somatic symptoms.
timeFrame: 24 months
measure: Quality of life metric.
timeFrame: 24 months
measure: Functional impairment.
timeFrame: 24 months
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Queen Square Institute of Neurology
Study officials:
affiliation: UCL/UCLH
name: Mahinda Yogarajah, PHD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Quadt 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.