Status:
RECRUITING
Heart Rate Variability Biofeedback Training in Psychogenic Disorders
Lead Sponsor:
University Hospital, Montpellier
Conditions:
Psychogenic Dystonia
Eligibility:
All Genders
18-75 years
Phase:
NA
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 extensiv...
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 n...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
April 30 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2026
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04777825
Start Date
April 30 2021
End Date
August 1 2026
Last Update
May 28 2024
Active Locations (1)
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1
Montpellier University Hospital
Montpellier, France