Heart Rate Variability Biofeedback Training in Psychogenic Disorders

Official title

Evaluation of the Effectiveness of a Heart Rate Variability Biofeedback Training in the Management of Dysfunctional (Somatoform) Disorders

Overview

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.

Interventions

• Other Heart rate variability biofeedback training (Symbiocenter)
  12 sessions of thirty minutes. Patients will participate through several serious game associated with HRV biofeedback training
• 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).

Primary outcome measures

• Variability of the cervical dystonia at 6 months [Time frame: 6 months]

Secondary outcome measures (11)

• Variability of the cervical dystonia at 3 months [Time frame: 3 months]
• Quality of life assessment in cervical dystonia at 3 months [Time frame: 3 months]
• Quality of life assessment in cervical dystonia at 6 months [Time frame: 6 months]
• Quality of life assessment at 3 months [Time frame: 3 months]
• Quality of life assessment at 6 months [Time frame: 6 months]
• Assessment of the severity of depression at 3 month [Time frame: 3 months]
• Assessment of the severity of depression at 6 month [Time frame: 6 months]
• Assessment of the anxiety at 3 month [Time frame: 3 months]
• Assessment of the anxiety at 6 month [Time frame: 6 months]
• satisfaction with the care [Time frame: 6 months]
• medical nomadism index [Time frame: 6 months]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Supportive care

Study locations

France · 1 center

• Montpellier University Hospital — Montpellier

Identifiers

NCT: NCT04777825 · RECHMPL19_0346

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗