Active — Not RecruitingNot Applicable

Clinical Evaluation of HRV Biofeedback in Functional Neurological Disorders Compared to Placebo

Canada31 participantsStarted 2024-09-09

Plain-language summary

Evaluation of the clinical effects of the Heart Rate Variability biofeedback training with patients suffering from Functional neurological Disorders compared with placebo.

Who can participate

Age range

18 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Functional Neurological Disorders (FND) diagnosis must be medically established * Participants must have a smartphone (android ou Iphone) * Participants must be of the age of majority * Participants must have signed an informed consent * Sufficiently fluent in French to understand study documents and instructions * Consistency in performing repeated questionnaires * Normal or corrected-to-normal visual acuity Exclusion Criteria: * Specially protected participants: juveniles, pregnant womens, nursing mothers, law's protection peoples * Participants suffering from a severe psychiatric disease needing specialised attention * History of severe neurosurgical pathology * Alcohol dependence or drug use * Participants suffering from or have suffered from a severe disease causing autonomic dysfunctions (heart failure, asthma, blood disease, renal failure, peripheral neuropathy, vagotomy, thyroid disorder, alcoholism, liver disease, amyloidosis) * Participants taking medication which could be impact autonomic nervous system activity (anticholinergic, antiarrhythmics, clonidine, beta-blockers, tricyclic anti-depressants, metronidazole) * Participants placing under judicial or administrative supervisions

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Patient Clinical Global Impression Score

Timeframe: Day 1 (V1)

Patient Clinical Global Impression Score

Timeframe: Up to 40 days from V1 (V2)

Patient Clinical Global Impression Score

Timeframe: Up to 80 days from V1 (V3)

Patient Clinical Global Impression Score

Timeframe: Up to 180 days from V1 (V4)

Patient Clinical Global Impression Score

Timeframe: Up to 360 days from V1 (V5)

Clinician Clinical Global Impression Score

Timeframe: Day 1 (V1)

Clinician Clinical Global Impression Score

Timeframe: Up to 40 days from V1 (V2)

Trial details

NCT IDNCT06422819

SponsorCentre hospitalier de l'Université de Montréal (CHUM)

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-05

View on ClinicalTrials.gov More Functional Neurological Disorder trials

Who can participate

Age range

18 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Patient Clinical Global Impression Score

Timeframe: Day 1 (V1)

Patient Clinical Global Impression Score

Timeframe: Up to 40 days from V1 (V2)

Patient Clinical Global Impression Score

Timeframe: Up to 80 days from V1 (V3)

Patient Clinical Global Impression Score

Timeframe: Up to 180 days from V1 (V4)

Patient Clinical Global Impression Score

Timeframe: Up to 360 days from V1 (V5)

Clinician Clinical Global Impression Score

Timeframe: Day 1 (V1)

Clinician Clinical Global Impression Score

Timeframe: Up to 40 days from V1 (V2)