Neurovegetative Decoupling in Somatoform Disorders : Biofeedback Interest (BIOFEESOMATO)

Grenoble Alpes University Hospital Center (CHU)

Status: Terminated

Conditions: Irritable Bowel Syndrome; Somatoform Disorders; Psychogenic Non-Epileptic Seizure

Treatments: Behavioral: Heart rate variability Biofeedback [HRV-BFB]

Study type: Interventional

Funder types: Other

Identifiers

NCT04807933

2020-A02155-34

Details and patient eligibility

About

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-brain decoupling.

Full 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 of vulnerability behind the large variability of the clinical symptoms regarding the SD. In this context, the lead of the neurovegetative disturbances started receiving attention following some studies that suggested the autonomic nervous system [ANS] disturbances concerning a somatoform disorder, independently of its form. Two different neurovegetative endophenotypes (individual autonomic profiles) were highlighted: a functional neurovegetative profile (high vagal tone) and a dysfunctional neurovegetative profile (low vagal tone).

A dysfunctional neurovegetative profile could be accompanied by a chronic decoupling in the brain-visceral axis according as the ANS is considered as a bidirectional communication system linked the central nervous system [CNS] and the viscera. Depending on the types of the neurovegetative profiles, different degrees of cognitive-emotional vulnerability and a higher or a lower level of acceptance of the illness could be supposed. Finally, recent findings defend the idea of the traumatic experiences as a determining factor to develop a SD.

In accordance to the last notions regarding the SD, some therapeutic approaches could be interesting specifically techniques focusing on the vagal nerve. In this context, biofeedback [BFB] could provide a powerful method to restore the clinical and physiological impairments.

As a consequence, the main objective is to evaluate the physiological and clinical effects of the BFB training with patients suffering from SD: Irritable Bowel Syndrome [IBS] or Psychogenic Non Epileptic Seizure [PNES]. The investigators make the prediction that the patients will be more or less responding to the biofeedback depending on their neurovegetative profile. A clustering will be performed in advance to identify the patients having a dysfunctional neurovegetative profile and patients having a functional neurovegetative profile. It will also permit to the investigators to confirm the hypothesis about the existence of two neurovegetative profiles related to a visceral-brain decoupling concerning the SD, independently of its form. To attest to it, 2 types of somatoform disorders will be analyzed: the irritable bowel syndrome manifesting by peripheral symptoms and the psychogenic non-epileptic seizures manifesting by central symptoms. Then the investigators will carry out a psycho-social exploration to demonstrate a higher cognitive-emotional vulnerability and a higher traumatic event incidence in this particular population, depending on their autonomic profiles.

Enrollment: 46 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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46 participants in 2 patient groups

Experimental group (BFB training)

Experimental group

Description:

The participants assigned to the experimental group will do the biofeedback training using the Emwave software during the intervention period (T2-T3). The biofeedback software (Emwave Pro®) includes a photoplethysmography sensor that can be positioned on the earlobe. The installation of the program and the explanations needed for using it, will be done during the second session (T2). According to the guidelines, a fractional training is proposed 5 minutes, 3 times a day for 24 days (T2-T3).

Treatment:

Behavioral: Heart rate variability Biofeedback [HRV-BFB]

Control group (no BFB training)

No Intervention group

Description:

The participants assigned to the experimental group will not do a specific exercise during the intervention period (T2-T3).