Heart Rate Variability Biofeedback Training in Psychogenic Disorders

Psychogenic Dystonia Clinical Trial

— ECoDys  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04777825
• Other study ID #: RECHMPL19_0346
• Status: Recruiting
• Phase: N/A
• Start date: April 30, 2021
• Est. completion date: August 2026

Study information

• Verified date: May 2024
• Source: University Hospital, Montpellier
• Contact: Emily SANREY, MSc
• Phone: 467337445
• Email: e-sanrey[@]chu-montpellier.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: August 2026
• Est. primary completion date: August 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Dystonia
• Dystonic Disorders
• Psychogenic Dystonia

Intervention

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

Locations

Country	Name	City	State
France	Montpellier University Hospital	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Quality of life assessment in cervical dystonia at 3 months	Measured by the Craniocervical Dystonia Questionnaire (CDQ24) scale	3 months
Secondary	Quality of life assessment in cervical dystonia at 6 months	Measured by the Craniocervical Dystonia Questionnaire (CDQ24) scale	6 months
Secondary	Quality of life assessment at 3 months	Measured by SF-36 scale	3 months
Secondary	Quality of life assessment at 6 months	Measured by SF-36 scale	6 months
Secondary	Assessment of the severity of depression at 3 month	Measured by Beck Depression Inventory (BDI-II) scale	3 months
Secondary	Assessment of the severity of depression at 6 month	Measured by the Beck Depression Inventory (BDI-II) scale	6 months
Secondary	Assessment of the anxiety at 3 month	Measured by the State-Trait Anxiety Inventory (STAI A & B) scale	3 months
Secondary	Assessment of the anxiety at 6 month	Measured by the State-Trait Anxiety Inventory (STAI A & B) scale	6 months
Secondary	satisfaction with the care	satisfaction's VAS	6 months
Secondary	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