RecruitingNAINTERVENTIONAL

Heart Rate Variability Biofeedback Training in Psychogenic Disorders

This study is investigating a treatment called Heart Rate Variability (HRV) biofeedback for people diagnosed with psychogenic dystonia. This condition causes abnormal head postures and sometimes pain, and often isn't helped by standard treatments. The researchers want to see if teaching people to control their heart rate variability – a natural variation in the time between heartbeats – can reduce pain, improve head posture, and help with feelings of anxiety and depression. Participants will attend 12 sessions of HRV biofeedback over six months. This non-invasive treatment focuses on breathing techniques to increase harmony between the heart and breathing, aiming to help patients manage their symptoms.

At a glance

Status

Recruiting

Phase

Sponsor

University Hospital, Montpellier

Enrolment target

Start

30 Apr 2021

Estimated completion

01 Aug 2026

Psychogenic Dystonia

What is this study about?

This study is exploring a new approach for people who have been diagnosed with psychogenic dystonia. This is a condition where people experience unusual head movements, which might have initially been thought to be a different type of dystonia. However, after careful checks by doctors, it's found that these movements are linked to psychological factors, rather than primarily physical nerve damage. For people with this condition, existing treatments like surgery or standard talking therapies often aren't suitable or fully effective, meaning they might struggle to find lasting relief.

The research is focusing on a technique called Heart Rate Variability (HRV) biofeedback. This isn't a medicine, but a way to help you learn to control some of your body's automatic functions, like your heart rate. Your heart rate naturally changes slightly with each breath, and this variation is called heart rate variability. By learning to make your breathing and heart rhythm more 'in sync,' using special equipment, the hope is that you can reduce your pain, improve your head posture, and feel better overall, including less anxiety and depression.

Participants will attend regular sessions over six months where they learn and practice these biofeedback techniques. The team hopes that this non-invasive method will help people manage their condition better and improve their quality of life. It's a safe and gentle approach that looks at how your body and mind work together.

Key takeaways

This study explores a non-drug treatment (HRV biofeedback) for psychogenic dystonia.
It aims to improve abnormal head posture, pain, anxiety, and depression.
Participants will attend 12 biofeedback training sessions over six months.
The treatment helps you learn to control your body's natural rhythms.
It's generally considered a safe, non-invasive approach.
You can stop participating at any time.

Who may be eligible?

To join this study, you need to be an adult between 18 and 75 years old and have been diagnosed with psychogenic dystonia, specifically experiencing abnormal head posture. This diagnosis means your physical symptoms are thought to be linked to psychological factors, even if doctors can't find a clear physical cause. You also need to be a part of the UK's social security scheme.

There are some reasons why you wouldn't be able to join. For example, if you are pretending to be ill (known as 'simulation') for personal gain, or if you have severe memory or thinking problems. You also can't be pregnant or planning to get pregnant, or currently breastfeeding. If you're receiving certain other treatments for your condition, such as Botox injections, psychotherapy (like CBT or mindfulness), or if you're taking part in another clinical study, you might not be eligible. Missing more than 30% of the planned sessions would also make you unsuitable, as would being unable to give your informed consent.

The research team will carefully check all these points with you to make sure the study is right for you and that you're right for the study.

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.

Are you between 18 and 75 years old?
Do you have a diagnosis of psychogenic dystonia with abnormal head posture?
Are you not currently pregnant or breastfeeding, and not planning a pregnancy?
Are you able to attend 12 sessions over six months?
Are you not taking part in most other clinical trials or specific psychotherapies?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll have 12 sessions of Heart Rate Variability (HRV) biofeedback training spread over six months. This means you'll typically have two sessions per month. During these sessions, you'll learn techniques to help you control your heart rate and breathing, using specialized equipment. You won't be given any new medications specifically for the study, but you can continue taking your usual pain relief if it's a common type. The total duration of your active involvement in the training is six months. There will also be some initial assessments to make sure the study is right for you, and follow-up checks to see how you're doing.

Potential risks and benefits

Participating in this study might offer several potential benefits, such as a possible reduction in pain and abnormal head posture, and improvements in anxiety, depression, and overall quality of life. This biofeedback training is a non-invasive treatment, meaning it doesn't involve surgery or strong medications. As with any study, there are always some potential risks, though for HRV biofeedback, these are generally considered very low. You might experience some mild fatigue from concentrating during sessions, but serious side effects are not expected. No medical recommendations are being made, and it's important to remember that you are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Montpellier University Hospital
Verified postcode
Montpellier, France· Recruiting

Common questions

What is 'psychogenic dystonia'?

It's a condition where you have unusual movements or postures, like in your head or neck, that are believed to be linked to psychological factors, rather than a clear physical cause.

What is Heart Rate Variability (HRV) biofeedback?

It's a technique that teaches you to control your body's automatic functions, like the slight changes in your heartbeat with each breath, to improve your symptoms.

Will I have to take any new medicines?

No, this study does not involve new medications. It focuses on a non-drug therapy using biofeedback training.

How long will the study last if I join?

You will attend 12 treatment sessions over a period of six months, plus initial assessments and follow-up checks.

What if I decide I don't want to continue?

You can leave the study at any point, and it won't affect your ongoing medical care.

How to find out more

Emily SANREY, MSc

e-sanrey@chu-montpellier.fr 467337445 Official trial record

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