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

NCT06105996 | Recruiting DMC

• 3 other identifiers: 15556332259923/NS/0075
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Psychogenic Nonepileptic Seizures; Dissociative Seizures; Psychogenic Pseudoseizure; Functional Neurological Disorder; Non Epileptic Seizure

Keywords

interoception; functional seizures; functional neurological disorder

Outcome Measures

Primary Outcomes (4)

• 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

• Proportion of participants who complete the ADIE-FS programme of treatment.

  Feasibility measure

  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

  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

  24 months

Secondary Outcomes (11)

• Cardiac interoceptive accuracy scores

  24 months

• Cardiac interoceptive sensibility scores

  24 months

• Cardiac interoceptive awareness scores

  24 months

• Seizure frequency and bothersomeness

  24 months

• Levels of physical activity.

  24 months

Study Arms (2)

Interoceptive training

EXPERIMENTAL

Participants will undergo 6 sessions of cardiac interoceptive training.

Behavioral: Interoceptive training

Treatment as usual arm

NO INTERVENTION

Participants will undergo treatment as usual.

Interventions

Interoceptive training BEHAVIORAL

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.

Interoceptive training

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University College, London: lead
• Columbia University: collaborator

Study Sites (1)

Queen Square Institute of Neurology

London, WC1N 3BG, United Kingdom

RECRUITING

Related 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. Epilepsia. 2020 Jun;61(6):1156-1165. doi: 10.1111/epi.16532. Epub 2020 Jun 5.

  PMID: 32501547 RESULT

• 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.

  PMID: 34401684 RESULT

MeSH Terms

Conditions

Psychogenic Nonepileptic Seizures; Conversion Disorder; Seizures

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Somatoform Disorders; Mental Disorders

Study Officials

• Mahinda Yogarajah, PHD

  UCL/UCLH

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pushpsen Joshi, PHD

CONTACT

020 3447 5557; Uclh.randd@nhs.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Participants will be assessed at the end of the study by members of the research team who have been blinded to whether the participant was randomised to the intervention group of the study, or the treatment as usual group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants in the study will be randomised to the intervention group (interoceptive training) or the treatment as usual group.

Study Record Dates

• First Submitted: October 9, 2023
• First Posted: October 30, 2023
• Study Start: January 10, 2024
• Primary Completion: May 1, 2024
• Study Completion: May 1, 2024
• Last Updated: March 4, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)