RecruitingNAINTERVENTIONAL

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

This research is testing a new approach called Heart Rate Variability Biofeedback (HRV-BFB) for people with Functional Neurological Disorder (FND). FND can cause a variety of symptoms, and scientists believe problems with how the body's control system (autonomic nervous system) works might play a role. HRV-BFB is a gentle method that teaches you to control some of these body functions yourself. This study aims to find out if HRV-BFB can help improve symptoms and overall well-being for adults with FND, compared to a fake treatment. The researchers hope to understand more about FND and find more personalised ways to help people in the future.

At a glance

Status

Recruiting

Phase

Sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Enrolment target

Start

09 Sep 2024

Estimated completion

01 May 2027

Functional Neurological Disorder

What is this study about?

Functional Neurological Disorder (FND) can be a really challenging condition, causing many different physical symptoms, even though scans and standard tests might look normal. It's one of the most common reasons people see a neurologist, but we don't fully understand why it happens.

Recent research suggests that there might be a link between FND and how our bodies handle emotions and how our "automatic" nervous system (which controls things like heart rate and breathing without us thinking about it) functions. The idea is that some people with FND might have unhelpful patterns in how their automatic nervous system works.

This study is exploring a new, gentle technique called Heart Rate Variability Biofeedback (HRV-BFB). This method teaches you to gain some control over your body's automatic responses, specifically your heart rate. It has shown promising results in other areas, and researchers believe it could be particularly helpful for FND patients by helping to rebalance their automatic nervous system. The main goal is to see if HRV-BFB actually improves symptoms, how people function in daily life, and their overall quality of life, compared to a placebo (a sham version of the treatment) in adults with FND.

Key takeaways

This study is testing a new, gentle FND treatment called Heart Rate Variability Biofeedback.
It aims to see if this treatment improves FND symptoms and quality of life compared to a fake treatment.
Researchers think it could help with how the body's automatic systems work in FND.
You'll have regular check-ups and switch between the real and pretend treatments without knowing which is which.
You need a confirmed FND diagnosis and to be an adult with a smartphone and good French language skills.
You can stop participating at any time.

Who may be eligible?

To join this study, you need to be an adult between 18 and 70 years old and have a confirmed diagnosis of Functional Neurological Disorder (FND) from a doctor. You'll also need to have a smartphone (either Android or iPhone) and be comfortable speaking and understanding French, as the study materials and instructions will be in French. You should also be able to complete questionnaires regularly and have normal or corrected vision.

There are some reasons you wouldn't be able to join. For example, if you are pregnant, breastfeeding, under 18, or have certain severe psychiatric illnesses. If you have a history of serious brain surgery, alcohol or drug dependence, or a severe medical condition that affects your body's automatic functions (like serious heart, kidney, or thyroid problems), you wouldn't be able to take part. Also, if you are taking certain medications that can affect your automatic nervous system, or are currently under legal or administrative supervision, you wouldn't be eligible.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Do I have a confirmed diagnosis of Functional Neurological Disorder from a doctor?
Am I aged between 18 and 70 years old?
Do I own a smartphone (Android or iPhone)?
Can I comfortably understand French and follow instructions in French?
Am I able to complete questionnaires regularly and consistently?
Do I have normal vision or wear glasses/contact lenses that correct my vision to normal?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll first have a thorough check-up. This will involve looking at your symptoms, how well you can do daily tasks, your quality of life, and any other health conditions you might have. You'll also complete a task related to emotions and have some special measurements taken of your body's automatic functions.

Then, over a period, you will receive one type of treatment (either the real Heart Rate Variability Biofeedback or the pretend version) and then switch to the other. You won't know which one you are getting at any given time. Throughout the study, your symptoms, ability to function, and quality of life will be checked regularly before and after each treatment. The emotional tasks and automatic function measurements will also be repeated at these times to see how things change. The total duration of your participation in the study is not specified, but it will involve repeat visits for assessments and interventions.

Potential risks and benefits

Participating in this study might offer you the chance to try a new and gentle technique that could potentially improve your FND symptoms, your ability to do daily activities, and your overall quality of life. However, there's always a chance that the treatment might not work for you, or you might receive the placebo. The known risks of Heart Rate Variability Biofeedback are generally low, as it's a non-invasive technique, but any potential discomfort or inconvenience from participating in the assessments will be carefully managed. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Université de Montréal's affiliated Hospital Research Centre (CRCHUM)
Verified postcode
Montreal, Canada· Recruiting

Common questions

What is Heart Rate Variability Biofeedback?

It's a gentle technique that teaches you to control your body's automatic responses, specifically focusing on your heart rate, to help improve your health.

What is Functional Neurological Disorder (FND)?

FND is a condition where problems occur with how the brain and body send and receive signals, causing a range of physical symptoms even when standard tests are normal.

Will I know if I'm getting the real treatment or the pretend one?

No, you won't know if you're receiving the actual Heart Rate Variability Biofeedback or the pretend version. This helps ensure the study results are fair.

How long will the study last for each person?

The study involves different stages of treatment and assessments, but the exact total duration for an individual participant isn't detailed here.

Will I have to pay to participate?

Clinical trials typically cover the costs related to the study intervention, but this information is not explicitly mentioned here. You should ask the study team.

How to find out more

Jasmine Carlier, PhD student

jasmine.carlier.chum@ssss.gouv.qc.ca 514-890-8000 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.