ADIE-FS - Aligning Dimensions of Interoceptive Experience in Patients With Functional Seizures

Functional Neurological Disorder Clinical Trial

— ADIE-FS  

Official title:

ADIE-FS - Aligning Dimensions of Interoceptive Experience in Patients With Functional Seizures

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06105996
• Other study ID #: 155563
• Secondary ID: 32259923/NS/0075
• Status: Recruiting
• Phase: N/A
• Start date: January 10, 2024
• Est. completion date: May 1, 2024

Study information

• Verified date: March 2024
• Source: University College, London
• Contact: Pushpsen Joshi, PHD
• Phone: 020 3447 5557
• Email: Uclh.randd[@]nhs.net
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: May 1, 2024
• Est. primary completion date: May 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Conversion Disorder
• Dissociative Seizures
• Functional Neurological Disorder
• Nervous System Diseases
• Seizures

Intervention

Behavioral:
• Interoceptive training
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.

Locations

Country	Name	City	State
United Kingdom	Queen Square Institute of Neurology	London

Sponsors (2)

Lead Sponsor	Collaborator
University College, London	Columbia University

Country where clinical trial is conducted

United Kingdom, 

References & Publications (2)

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. E — View 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;39:10104 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	24 months
Primary	Proportion of participants who complete the ADIE-FS programme of treatment.	Feasibility measure	24 months
Primary	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	24 months
Primary	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	24 months
Secondary	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.	24 months
Secondary	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.	24 months
Secondary	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.	24 months
Secondary	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.	24 months
Secondary	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.	24 months
Secondary	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.	24 months
Secondary	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.	24 months
Secondary	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.	24 months
Secondary	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.	24 months
Secondary	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.	24 months
Secondary	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.	24 months