Status:
TERMINATED
Neurovegetative Decoupling in Somatoform Disorders : Biofeedback Interest
Lead Sponsor:
University Hospital, Grenoble
Collaborating Sponsors:
Laboratoire de Psychologie et NeuroCognition
Laboratoire interuniversitaire de psychologie - LIP-PC2S
Conditions:
Somatoform Disorders
Irritable Bowel Syndrome
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
Evaluation of the physiological and clinical effects of the biofeedback training with patients suffering from somatoform disorders, depending on their neurovegetative profile related to a visceral-bra...
Detailed Description
Somatoform disorders \[SD\] are defined as physiological function or organ disturbances unexplained by a specific diagnosis criterion. Some approaches have recently defended the idea of common factors...
Eligibility Criteria
Inclusion
- Somatoform disorders (IBS or PNES) diagnosis must be established by the partner doctors
- Participants must have home computer
- Participants must be of the age of majority
- Participants must be registered for social security
- Participants must have signed an informed consent
Exclusion
- Specially protected participants (under clauses L1121-5 and L1121-8 by the code of public health): juveniles, pregnant womens, nursing mothers, law's protection peoples
- Participants suffering from a severe psychiatric disease needing specialised attention
- Participants suffering from or have suffered from a severe disease causing autonomic dysfunctions (heart failure, asthma, blood disease, renal failure, peripheral neuropathy, vagotomy, thyroid disorder, alcoholism, liver disease, amyloidosis)
- Participants taking medication which could be impact autonomic nervous system activity (anticholinergic, antiarrhythmics, clonidine, beta-blockers, tricyclic anti-depressants, metronidazole)
- Participants placing under judicial or administrative supervisions
- Participants were compensated more than 4500 euros because of his research protocol participation concerning human over the 12 months prior to the actual study
- Participants being not be able to contact in emergency
- Participants being in an exclusion period from another study
Key Trial Info
Start Date :
March 16 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 5 2023
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT04807933
Start Date
March 16 2021
End Date
September 5 2023
Last Update
December 10 2024
Active Locations (1)
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1
University Hospital, Grenoble Alpes
Grenoble, Isère, France, 38700