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

Phase

N/A

Condition

Hypochondriasis

Anxiety Disorders

Neurologic Disorders

Treatment

Interoceptive training

Clinical Study ID

NCT06105996

155563

23/NS/0075

322599

Ages > 18
All Genders

Study 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.

Eligibility Criteria

Inclusion

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 asper International League Against Epilepsy (ILAE) criteria

Exclusion

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 rheumatoidarthritis) causing functional impairment (e.g., in gait or basic activities of dailyliving)
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 thestudy.

Study Design

Interoceptive training

January 10, 2024

May 01, 2024

Study 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.

Connect with a study center

Queen Square Institute of Neurology
London, WC1N 3BG
United Kingdom
Active - Recruiting

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