RecruitingACTRN12622000525785

The effectiveness and acceptability of Breathing Control Training (BCT) for Functional Seizures (FS)

Breathing Control Training (BCT) as a Treatment for Functional Seizures (FS) - a multi-centre, assessor blinded, randomised controlled efficacy and acceptability trial


Sponsor

University of Melbourne

Enrollment

220 participants

Start Date

Feb 20, 2024

Study Type

Interventional

Conditions

Summary

We do not understand very clearly what causes Functional Seizures (FS; also known as Non-Epileptic Seizures, or Psychogenic Non-epileptic Seizures) or how to treat them. Previous research suggests that rapid breathing (called hyperventilating) can provoke an episode in some people who have FS. We think that if these people could learn to control their breathing so that they didn’t breathe too quickly this might stop them having seizures. We have tested this on a few people with FS by teaching them something called Breathing Control Training (or ‘BCT’ for short) and found that most of their seizures either stopped or became much less frequent. BCT is a treatment provided by physiotherapists for people with asthma so they can manage their hyperventilation symptoms, but we want to see if it works for people who experience Functional Seizures (FS). In this research project, we will provide BCT, or a comparison treatment known as 'Befriending', to 220 people with FS so we can determine how many people BCT works for, and which people it does help (so we know who to recommend the treatment to in future). We will also assess if BCT is safe for FS (i.e. does it cause any side effects); if it is acceptable (i.e. do people like it, and find it easy to implement); and if it is an affordable treatment option for people with FS.


Eligibility

Sex: Both males and femalesMin Age: 16 Yearss

Plain Language Summary

Simplified for easier understanding

Functional seizures look and feel similar to epileptic seizures but are not caused by abnormal electrical activity in the brain. They are instead linked to how the brain and body respond to stress and distress. Research has found that overbreathing (hyperventilation) can trigger functional seizures in many people, suggesting that learning to control breathing patterns might help prevent them from occurring. This study tests a treatment called Breathing Control Training (BCT) — a technique originally developed for asthma patients — to see whether it can reduce the frequency of functional seizures. BCT is compared to a supportive social programme called Befriending. Two hundred and twenty participants will be recruited to find out how well BCT works, which people benefit most, and whether it is a safe and affordable option. You may be eligible if you are 16 years or older, have been diagnosed with functional seizures by an epilepsy specialist based on a video EEG recording, experience at least two seizures per month, and have sufficient English to complete questionnaires and understand the treatment. People who also have diagnosed epilepsy or are currently receiving other breathing therapies are not eligible.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Breathing Control Training (BCT) teaches appropriate rate and depth of breathing and the development of a pattern of breathing appropriate to a person's current physical activity level. The eliminatio

Breathing Control Training (BCT) teaches appropriate rate and depth of breathing and the development of a pattern of breathing appropriate to a person's current physical activity level. The elimination of dysfunctional breathing patterns, including hyperinflation and hyperventilation, is discussed. Diaphragmatic breathing is taught, and emphasis is placed on calm, slow, nasal expiration. Education on stress responses and their interactions with breathing patterns is given. The integration of appropriate breathing and relaxation techniques into daily living activities is encouraged. Initially exercises are taught in a semi-recumbent position, progressing to sitting, then standing, then during everyday activities. Finally, the integration of breathing and relaxation techniques into speech is taught and practiced. In this project, BCT will be delivered by a respiratory physiotherapist with specific training in this technique at the participant’s primary care hospital, or via Telehealth if required. The physiotherapist will conduct a 60min initial session with the participant (one-on-one) and a 30min refresher (‘booster’) session (one-on-one) 4-weeks later. Participants will be encouraged to practice the learnt BCT techniques daily (5-10 minutes, twice daily) and record their adherence in a calendar style diary. The diary will be be reviewed by the physiotherapist at the booster session and compliance recorded in the participant's case report form, as well if they attended both treatment sessions (initial and booster).


Locations(5)

Austin Health - Austin Hospital - Heidelberg

VIC, Australia

St Vincent's Hospital (Melbourne) Ltd - Fitzroy

VIC, Australia

Royal Melbourne Hospital - City campus - Parkville

VIC, Australia

The Alfred - Melbourne

VIC, Australia

Christchurch, New Zealand

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ACTRN12622000525785


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