Heart Rate Variability Biofeedback Training in Psychogenic Disorders (ECoDys)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Psychogenic Dystonia
• Intervention / Treatment: Other: Heart rate variability biofeedback training (Symbiocenter); Other: psychoeducation session

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.

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Emily SANREY, MSc; Phone Number: +33 467337445; Email: e-sanrey@chu-montpellier.fr
• Study Contact Backup: Name: Valérie GIL, CTA; Phone Number: +33 467337464; Email: v-gil@chu-montpellier.fr

Study Locations

• France
  • Montpellier, France
    • Recruiting
    • Montpellier University Hospital
    • Contact: Emily SANREY, MSc; Phone Number: +33 467337445; Email: e-sanrey@chu-montpellier.fr
    • Contact: Valérie GIL, CTA; Phone Number: +33 467337464; Email: v-gil@chu-montpellier.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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).
Other: control; During the inclusion visit, all patients will benefit from a psychoeducation session supervised by the psychologist.	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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Variability of the cervical dystonia at 6 months	Measured by the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) scale. The total score is 0 (better outcome) to 85 (worse outcome)	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Variability of the cervical dystonia at 3 months	Measured by the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) scale. The total score is 0 (better outcome) to 85 (worse outcome)	3 months
Quality of life assessment in cervical dystonia at 3 months	Measured by the Craniocervical Dystonia Questionnaire (CDQ24) scale	3 months
Quality of life assessment in cervical dystonia at 6 months	Measured by the Craniocervical Dystonia Questionnaire (CDQ24) scale	6 months
Quality of life assessment at 3 months	Measured by SF-36 scale	3 months
Quality of life assessment at 6 months	Measured by SF-36 scale	6 months
Assessment of the severity of depression at 3 month	Measured by Beck Depression Inventory (BDI-II) scale	3 months
Assessment of the severity of depression at 6 month	Measured by the Beck Depression Inventory (BDI-II) scale	6 months
Assessment of the anxiety at 3 month	Measured by the State-Trait Anxiety Inventory (STAI A & B) scale	3 months
Assessment of the anxiety at 6 month	Measured by the State-Trait Anxiety Inventory (STAI A & B) scale	6 months
satisfaction with the care	satisfaction's VAS	6 months
medical nomadism index	The index of "presumed nomadism" is the difference between the number of different doctors consulted and the number of different specialties of these same doctors. Any patient whose index is ≥ 3 over a period of 6 months is presumed nomadic.	6 months

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier
• Investigators: Principal Investigator: Philippe COUBES, MD, PhD, Montpellier University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 30, 2021
• Primary Completion (Anticipated): April 1, 2024
• Study Completion (Anticipated): April 1, 2024

Study Registration Dates

• First Submitted: September 8, 2020
• First Submitted That Met QC Criteria: March 1, 2021
• First Posted (Actual): March 2, 2021

Study Record Updates

• Last Update Posted (Actual): May 7, 2021
• Last Update Submitted That Met QC Criteria: May 6, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: Heart Rate Variability; Cervical dystonia; Functional neurosurgery; Psychogenic disorder
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Movement Disorders; Dyskinesias; Dystonia; Dystonic Disorders
• Other Study ID Numbers: RECHMPL19_0346

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No