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Behavioural Intervention

HRV Biofeedback for Functional Neurological Disorder (HRV_BFB_FND Trial)

N/A

Recruiting

Led By Dang Khoa Nguyen

Research Sponsored by Centre hospitalier de l'Université de Montréal (CHUM)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participants must be of the age of majority

Functional Neurological Disorders (FND) diagnosis must be medically established

Must not have

Participants suffering from or have suffered from a severe disease causing autonomic dysfunctions (e.g., heart failure, asthma, blood disease, renal failure, peripheral neuropathy, vagotomy, thyroid disorder, alcoholism, liver disease, amyloidosis)

History of severe neurosurgical pathology

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 360 days from v1 (v5)

Summary

"This trial will assess the impact of Heart Rate Variability biofeedback training on patients with Functional Neurological Disorders compared to a placebo."

Who is the study for?

This trial is for individuals with Functional Neurological Disorders, which can include symptoms like uncontrolled movements or blackouts without a clear physical cause. Participants should be diagnosed with conditions such as Conversion Disorder or similar nervous system disorders.

What is being tested?

The study is testing the effectiveness of Heart Rate Variability Biofeedback (HRV-BFB), a technique that may help patients control their body's responses to stress, compared to a placebo version of the same procedure (Pseudo HRV-BFB).

What are the potential side effects?

Since HRV-BFB involves non-invasive training sessions, side effects are minimal but could include discomfort from sitting still during sessions and potential frustration if no improvement in symptoms is perceived.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am legally considered an adult in my country.

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My diagnosis of a functional neurological disorder is confirmed by a doctor.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have or had a severe illness affecting my body's automatic functions.

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I have a history of serious brain or nerve surgery problems.

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I am taking medication that affects my nervous system.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 360 days from v1 (v5)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 360 days from v1 (v5)

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 360 days from v1 (v5) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Clinician Clinical Global Impression Score

Patient Clinical Global Impression Score

Quality of life Score

+1 more

Secondary study objectives

Alexithymia score

Alpha frequency (8-12Hz)

Beta frequency (13-30Hz)

+16 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Experimental group (HRV-BFB training)Experimental Treatment1 Intervention

Participants assigned to the experimental group will undergo HRV Biofeedback training using the Inner Balance Coherence Plus® software. This software incorporates a Bluetooth plethysmograph ear sensor, which will transmit cardiac pulse data to the Inner Balance Coherence Plus smartphone app, where the EmWave Pro® Plus software will extract HRV in real-time. This software will display the participant's HRV-BFB curve on their smartphone. The installation of the program and necessary instructions for its use will be provided at the first visit (V1). Fractional training sessions of 8 minutes will be recommended, twice daily for 30 days (during the period V1-V2 or the period V2-V3). Respiratory instructions will differ between the two interventions. During the HRV-BFB intervention, participants will be instructed to maximize their HRV.

Group II: Placebo Control group (Pseudo HRV-BFB training)Placebo Group1 Intervention

Participants assigned to the placebo group will undergo a pseudo HRV Biofeedback training using the same Inner Balance Coherence Plus® software and ear sensor. The software will similarly display the participant's HRV-BFB curve on their smartphone. The installation of the program and necessary instructions for its use will be provided at the first visit (V1). To manage placebo effects, the same fractional training sessions of 8 minutes will be recommended, twice daily for 30 days (during the period V1-V2 or the period V2-V3). Respiratory instructions will differ between the two interventions. During the placebo pseudo BFB training, participants will be instructed to no have specific effect on HRV.

0 / 5Eligibility criteria met