Heart Rate Variability Biofeedback Training in Psychogenic Disorders
- Conditions
- Psychogenic Dystonia
- Interventions
- Other: psychoeducation sessionOther: Heart rate variability biofeedback training (Symbiocenter)
- Registration Number
- NCT04777825
- Lead Sponsor
- University Hospital, Montpellier
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 40
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description control psychoeducation session During the inclusion visit, all patients will benefit from a psychoeducation session supervised by the psychologist. HRV biofeedback training Heart rate variability biofeedback training (Symbiocenter) 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. HRV biofeedback training psychoeducation session 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.
- Primary Outcome Measures
Name Time Method Variability of the cervical dystonia at 6 months 6 months Measured by the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) scale. The total score is 0 (better outcome) to 85 (worse outcome)
- Secondary Outcome Measures
Name Time Method Quality of life assessment in cervical dystonia at 3 months 3 months Measured by the Craniocervical Dystonia Questionnaire (CDQ24) scale
Quality of life assessment at 3 months 3 months Measured by SF-36 scale
Quality of life assessment at 6 months 6 months Measured by SF-36 scale
Assessment of the severity of depression at 3 month 3 months Measured by Beck Depression Inventory (BDI-II) scale
Assessment of the anxiety at 3 month 3 months Measured by the State-Trait Anxiety Inventory (STAI A \& B) scale
satisfaction with the care 6 months satisfaction's VAS
Variability of the cervical dystonia at 3 months 3 months Measured by the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) scale. The total score is 0 (better outcome) to 85 (worse outcome)
Assessment of the severity of depression at 6 month 6 months Measured by the Beck Depression Inventory (BDI-II) scale
medical nomadism index 6 months 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.
Assessment of the anxiety at 6 month 6 months Measured by the State-Trait Anxiety Inventory (STAI A \& B) scale
Quality of life assessment in cervical dystonia at 6 months 6 months Measured by the Craniocervical Dystonia Questionnaire (CDQ24) scale
Trial Locations
- Locations (1)
Montpellier University Hospital
🇫🇷Montpellier, France