Clinical trial NCT04777825: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Psychogenic Dystonia
Keywords: Cervical dystonia
Psychogenic disorder
Heart Rate Variability
Functional neurosurgery
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2021-03-02
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Variability of the cervical dystonia at 6 months
timeFrame: 6 months
Secondary outcomes:
measure: Variability of the cervical dystonia at 3 months
timeFrame: 3 months
measure: Quality of life assessment in cervical dystonia at 3 months
timeFrame: 3 months
measure: Quality of life assessment in cervical dystonia at 6 months
timeFrame: 6 months
measure: Quality of life assessment at 3 months
timeFrame: 3 months
measure: Quality of life assessment at 6 months
timeFrame: 6 months
measure: Assessment of the severity of depression at 3 month
timeFrame: 3 months
measure: Assessment of the severity of depression at 6 month
timeFrame: 6 months
measure: Assessment of the anxiety at 3 month
timeFrame: 3 months
measure: Assessment of the anxiety at 6 month
timeFrame: 6 months
measure: satisfaction with the care
timeFrame: 6 months
measure: medical nomadism index
timeFrame: 6 months
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Montpellier University Hospital
Study officials:
affiliation: Montpellier University Hospital
name: Philippe COUBES, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: