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Training the heart to calm the brain: a new hope for functional neurological disorders?

NCT ID NCT06422819

Symptom relief Sponsor: Centre hospitalier de l'Université de Montréal (CHUM) Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 14, 2026 · Last updated Aug 14, 2026

Summary

This trial tests whether heart rate variability biofeedback—a non-invasive technique that teaches people to control their heart rhythm—can ease symptoms of functional neurological disorders (FND), a condition where the brain and nervous system don't function properly despite no structural damage. About 31 adults with a confirmed FND diagnosis will be trained in this technique and compared to a placebo group. The study measures changes in symptom severity, quality of life, and daily functioning to see if this mind-body approach offers a new, drug-free treatment option.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Heart rate variability biofeedback (HRV-BFB), a non-invasive technique that uses real-time heart rate feedback to help people learn to control unconscious bodily processes and regulate the autonomic nervous system.
What this could lead to
If effective, HRV biofeedback could offer a drug-free, non-invasive way to reduce symptoms and improve quality of life for people with functional neurological disorders.
What could go wrong
This is a small early-stage trial, and the placebo effect can be strong with biofeedback. It is unclear whether benefits will last or apply to all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 31 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2024

Expected to finish

May 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 70 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

conversion disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Functional neurological disorder

Contacts and locations

Locations

  • Université de Montréal's affiliated Hospital Research Centre (CRCHUM)

    Montreal, Quebec, H2X 0C1, Canada

More trials for these conditions

Other studies related to the condition(s) this trial covers.