Actively Recruiting

Phase Not Applicable
Age: 18Years - 75Years
All Genders
NCT04777825

Heart Rate Variability Biofeedback Training in Psychogenic Disorders

Led by University Hospital, Montpellier · Updated on 2024-05-28

40

Participants Needed

1

Research Sites

274 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Heart Rate Variability Biofeedback Training in Psychogenic Disorders

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 to 75 years
  • Diagnosis meeting somatoform disorder characteristics as described in ICD-10 (F45)
  • Diagnosis of conversion disorder with functional neurological symptoms (ICD-10 equivalent F44.4) confirmed by multidisciplinary team after assessment
  • Benefiting from a social security scheme
Not Eligible

You will not qualify if you...

  • Simulation identified with obvious secondary benefit seeking (ICD-10 Z76.5 or DSM-V V65.2)
  • Scheduled botulinum toxin, psychotherapy, or professional relaxation therapy within 6 months (excluding usual analgesics)
  • Significant cognitive impairment (MoCa score 64 24/30)
  • Expected absence from at least 30% of sessions
  • Lack of informed consent
  • Pregnancy or planned pregnancy during study period, or breastfeeding
  • Major protected by law or under guardianship or curatorship
  • Participation in other ongoing research

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Montpellier University Hospital

Montpellier, France

Actively Recruiting

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Research Team

E

Emily SANREY, MSc

CONTACT

V

Valérie GIL, CTA

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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