Heart Rate Variability Biofeedback Training in Psychogenic Disorders
Recruiting now · Not applicable
Conditions studied: Psychogenic Dystonia
In brief
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.
Key facts
- Study ID
- NCT04777825
- Run by
- University Hospital, Montpellier
- People needed
- 40
- Starts
- 2021-04-30
- Expected to finish
- 2026-08-01
- Last updated by the study team
- 2024-05-28
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Montpellier University Hospital — Montpellier, France (enrolling)
Full record on ClinicalTrials.gov
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