Heart Rate Variability Biofeedback Training in Psychogenic Disorders

NCT ID: NCT04777825

Last Updated: 2024-05-28

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-30
• Study Completion Date: 2026-08-31

Brief Summary

To study whether Heart Rate Variability (HRV) biofeedback training can improve abnormal head posture and painful symptomatology in patients with "cervical dystonia" not selected for DBS after extensive screening in a specialized unit but diagnosed " dysfunctional ".

Patients of the respiratory coherence group will receive HRV biofeedback training for 12 sessions during a 6 months-period. The hypothesis is that this kind of physiological noninvasive therapy increasing coherence respiratory, will reduce pain and patient's complain about their psychogenic abnormal head posture. Improvement of anxiety, depression and quality of life are expected.

Detailed Description

Patients presenting with an isolated abnormal head posture, first diagnosed as cervical dystonia, demonstrated in fact, after neurological screening, to be of psychogenic origine. These patients are not candidate for functional surgery and, furthermore, usually refuse psychotherapy leading them to medical nomadism. This study proposes to evaluate the efficacy of an innovative intervention program based on Heart Rate Variability (HRV) biofeedback that promotes self-regulatory skills in dysfunctional movement disorders (DMD) patients in order to improve their condition and symptomatology.

Heart rate is under the control of efferent sympathetic and vagal activities directed to the sinus node, which are modulated by central brain stem (vasomotor and respiratory centers) and peripheral oscillators (oscillation in arterial pressure and respiratory movements). Spectral analysis of HRV is a reliable quantitative method for analyzing the modulatory effects of neural mechanisms on the sinus node. Several biofeedback protocols and assistive electronic technologies, such as proposed by SymbioCenter©, exist to enhance increase HRV and synchronize respiration with the heart rhythm. HRV biofeedback training appears to be an opportunity in the patient's management in order of preventing medical overconsuming. It is offering a safe and non-pharmacological alternative approach managed by a multidisciplinary team in a functional neurosurgery unit. It is expected that developing respiratory coherence in these patients will improve their painful symptomatology.

Conditions

Psychogenic Dystonia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

HRV biofeedback training

During the inclusion visit, all patients will benefit from a psychoeducation session supervised by the psychologist. This group of patients will also benefit from the HRV biofeedback training.

Group Type: EXPERIMENTAL

Heart rate variability biofeedback training (Symbiocenter)

Intervention Type: OTHER

12 sessions of thirty minutes. Patients will participate through several serious game associated with HRV biofeedback training

psychoeducation session

Intervention Type: OTHER

Each patient will therefore be presented individually with a Powerpoint consisting of 35 slides divided into 4 sub-sections explaining in a fun and educational format the physiological model of stress, the respiratory function and its benefits, presentation of various relaxation techniques and recommendations for reading (stress management, letting go, mindfulness meditation) and other tools to help relaxation (smartphone applications).

control

During the inclusion visit, all patients will benefit from a psychoeducation session supervised by the psychologist.

Group Type: OTHER

psychoeducation session

Intervention Type: OTHER

Each patient will therefore be presented individually with a Powerpoint consisting of 35 slides divided into 4 sub-sections explaining in a fun and educational format the physiological model of stress, the respiratory function and its benefits, presentation of various relaxation techniques and recommendations for reading (stress management, letting go, mindfulness meditation) and other tools to help relaxation (smartphone applications).

Interventions

Heart rate variability biofeedback training (Symbiocenter)

12 sessions of thirty minutes. Patients will participate through several serious game associated with HRV biofeedback training

Intervention Type: OTHER

psychoeducation session

Each patient will therefore be presented individually with a Powerpoint consisting of 35 slides divided into 4 sub-sections explaining in a fun and educational format the physiological model of stress, the respiratory function and its benefits, presentation of various relaxation techniques and recommendations for reading (stress management, letting go, mindfulness meditation) and other tools to help relaxation (smartphone applications).

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Age 18 to 75
• Responding to somatoform disorder characteristics as described in ICD-10 (F45: "The onset of physical symptoms associated with an insistent medical quest, persisting despite repeated negative assessments and statements by physicians that the symptoms have no organic basis. If there is a genuine physical disorder, it does not account for the nature or severity of the symptoms, or the distress or concerns of the subject. The multidisciplinary team will determine whether or not the diagnosis of conversion disorder (disorder with functional neurological symptoms) of the DSMV (300.11) [ICD-10 equivalent: F44.4 "dissociative disorder with abnormal movements"] is associated with the diagnosis of conversion disorder (disorder with functional neurological symptoms) of the DSMV (300.11) [ICD-10 equivalent: F44.4 "dissociative disorder with abnormal movements"], selected by the multidisciplinary team after a phase 1 assessment.
• Patient benefiting from a social security scheme

Exclusion Criteria

• Simulation identified with obvious search for secondary benefit according to the ICD-10 classification ( Z76.5 Simulator: Person pretending to be ill (with obvious motivation"), or DSM-V(V65.2)
• Any other specific PAT-specific CEP (botulinum toxin, psychotherapy and/or relaxation provided by a professional (CBT, ACT, Mindfulness, etc.)) scheduled within 6 months, with the exception of the usual analgesics (Tier I or II)Presenting significant cognitive impairment (MoCa test ≤ 24/30),
• Absence foreseeable at least 30% of the sessions,
• Lack of informed consent.
• Pregnancy or planned pregnancy during the study period, Pregnant or breastfeeding women
• Major protected by law or patient under guardianship or curatorship
• Participation in other ongoing research

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Montpellier

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Philippe COUBES, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Montpellier University Hospital

Locations

Montpellier University Hospital

Montpellier, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Emily SANREY, MSc

Role: CONTACT

e-sanrey@chu-montpellier.fr

467337445 ext. +33

Valérie GIL, CTA

Role: CONTACT

v-gil@chu-montpellier.fr

467337464 ext. +33

Facility Contacts

Emily SANREY, MSc

Role: primary

e-sanrey@chu-montpellier.fr

467337445 ext. +33

Valérie GIL, CTA

Role: backup

v-gil@chu-montpellier.fr

467337464 ext. +33

Other Identifiers

RECHMPL19_0346

Identifier Type: -

Identifier Source: org_study_id