Image

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

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

Recruiting
18 years and older
All
Phase N/A

Powered by AI

Overview

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.

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.

Study details
    Psychogenic Nonepileptic Seizures
    Dissociative Seizures
    Psychogenic Pseudoseizure
    Functional Neurological Disorder
    Non Epileptic Seizure

NCT06105996

University College, London

21 October 2025

Step 1 Get in touch with the nearest study center
We have submitted the contact information you provided to the research team at {{SITE_NAME}}. A copy of the message has been sent to your email for your records.
Would you like to be notified about other trials? Sign up for Patient Notification Services.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

  Other languages supported:

First name*
Last name*
Email*
Phone number*
Other language

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.