Clinical trial NCT04807933: Neurovegetative Decoupling in Somatoform Disorders : Biofeedback Interest
Official title: Neurovegetative Decoupling in the Visceral-brain Axis and Cognitive-emotional Vulnerability in Somatoform Disorders : Interest of Vagal Biofeedback
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Somatoform Disorders
Irritable Bowel Syndrome
Psychogenic Non-Epileptic Seizure
Keywords: Autonomic nervous system
Brain-gut axis
Endophenotype
Cognitive-emotional vulnerability
Traumas
Biofeedback
Heart rate variability
Vagal tone
Central nervous system
Enteric nervous system
Early life events
Somatoform disorders
Stress
Irritable bowel syndrome
Psychogenic non epileptic seizures
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
Collaborators: name: Laboratoire de Psychologie et NeuroCognition
name: Laboratoire interuniversitaire de psychologie - LIP-PC2S
First posted: 2021-03-19
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study requires 3 sessions (T1 / T2 / T3) with at least 24 days between each. The period (24 days) between the first session and the second session (T1-T2) will be considered as the control period. During the period, the participants will practice none exercise. The period (24 days) between the second session and the third session (T2-T3) will be considered as the intervention period. At the end of the second session (T2), the participants will be separated into two inter-subject groups: an experimental group performing BFB technique (3X5 min per day) in the intervention period (T2-T3) and a control group not performing a specific exercise in the intervention period (T2-T3).
Primary purpose: SUPPORTIVE_CARE

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-brain decoupling.

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: High frequency [HF] (0.15-0.40 Hz)
timeFrame: Day 1 (T1)
measure: High frequency [HF] (0.15-0.40 Hz)
timeFrame: Up to 25 days from T1 (T2)
measure: High frequency [HF] (0.15-0.40 Hz)
timeFrame: Up to 52 days from T1 (T3)
measure: Root mean square of successive RR interval differences [RMSSD]
timeFrame: Day 1 (T1)
measure: Root mean square of successive RR interval differences [RMSSD]
timeFrame: Up to 25 days from T1 (T2)
measure: Root mean square of successive RR interval differences [RMSSD]
timeFrame: Up to 52 days from T1 (T3)
Secondary outcomes:
measure: Low frequency [LF] (0.04-0.15 Hz)
timeFrame: Day 1 (T1)
measure: Low frequency [LF] (0.04-0.15 Hz)
timeFrame: Up to 25 days from T1 (T2)
measure: Low frequency [LF] (0.04-0.15 Hz)
timeFrame: Up to 52 days from T1 (T3)
measure: Low frequency [LF] 0.1 Hertz (0.075-0.108Hz)
timeFrame: Day 1 (T1)
measure: Low frequency [LF] 0.1 Hertz (0.075-0.108Hz)
timeFrame: Up to 25 days from T1 (T2)
measure: Low frequency [LF] 0.1 Hertz (0.075-0.108Hz)
timeFrame: Up to 52 days from T1 (T3)
measure: Total power (0-0.40 Hz)
timeFrame: Day 1 (T1)
measure: Total power (0-0.40 Hz)
timeFrame: Up to 25 days from T1 (T2)
measure: Total power (0-0.40 Hz)
timeFrame: Up to 52 days from T1 (T3)
measure: Ratio Low frequency / High frequency [LF / HF]
timeFrame: Day 1 (T1)
measure: Ratio Low frequency / High frequency [LF / HF]
timeFrame: Up to 25 days from T1 (T2)
measure: Ratio Low frequency / High frequency [LF / HF]
timeFrame: Up to 52 days from T1 (T3)
measure: Standard deviation of all NN intervals [SDNN]
timeFrame: Day 1 (T1)
measure: Standard deviation of all NN intervals [SDNN]
timeFrame: Up to 25 days from T1 (T2)
measure: Standard deviation of all NN intervals [SDNN]
timeFrame: Up to 52 days from T1 (T3)
measure: Skin conductance responses [SCR] frequency
timeFrame: Day 1 (T1)
measure: Skin conductance responses [SCR] frequency
timeFrame: Up to 25 days from T1 (T2)
measure: Skin conductance responses [SCR] frequency
timeFrame: Up to 52 days from T1 (T3)
measure: Skin conductance responses [SCR] amplitude
timeFrame: Day 1 (T1)
measure: Skin conductance responses [SCR] amplitude
timeFrame: Up to 25 days from T1 (T2)
measure: Skin conductance responses [SCR] amplitude
timeFrame: Up to 52 days from T1 (T3)
measure: Integrated skin conductance responses [ISCR]
timeFrame: Day 1 (T1)
measure: Integrated skin conductance responses [ISCR]
timeFrame: Up to 25 days from T1 (T2)
measure: Integrated skin conductance responses [ISCR]
timeFrame: Up to 52 days from T1 (T3)
measure: Pulsatility index variation [PI]
timeFrame: Day 1 (T1)
measure: Pulsatility index variation [PI]
timeFrame: Up to 25 days from T1 (T2)
measure: Pulsatility index variation [PI]
timeFrame: Up to 52 days from T1 (T3)
measure: Breathing rate
timeFrame: Day 1 (T1)
measure: Breathing rate
timeFrame: Up to 25 days from T1 (T2)
measure: Breathing rate
timeFrame: Up to 52 days from T1 (T3)
measure: Dominant power (0-0.15Hz)
timeFrame: Day 1 (T1)
measure: Dominant power (0-0.15Hz)
timeFrame: Up to 25 days from T1 (T2)
measure: Dominant power (0-0.15Hz)
timeFrame: Up to 52 days from T1 (T3)
measure: Total power (0-0.15Hz)
timeFrame: Day 1 (T1)
measure: Total power (0-0.15Hz)
timeFrame: Up to 25 days from T1 (T2)
measure: Total power (0-0.15Hz)
timeFrame: Up to 52 days from T1 (T3)
measure: Slow-waves frequency (physiological outcome)
timeFrame: Day 1 (T1)
measure: Slow-waves frequency (physiological outcome)
timeFrame: Up to 25 days from T1 (T2)
measure: Slow-waves frequency (physiological outcome)
timeFrame: Up to 52 days from T1 (T3)
measure: Delta frequency (0-4Hz)
timeFrame: Day 1 (T1)
measure: Delta frequency (0-4Hz)
timeFrame: Up to 25 days from T1 (T2)
measure: Delta frequency (0-4Hz)
timeFrame: Up to 52 days from T1 (T3)
measure: Theta frequency (4-7Hz)
timeFrame: Day 1 (T1)
measure: Theta frequency (4-7Hz)
timeFrame: Up to 25 days from T1 (T2)
measure: Theta frequency (4-7Hz)
timeFrame: Up to 52 days from T1 (T3)
measure: Alpha frequency (8-12Hz)
timeFrame: Day 1 (T1)
measure: Alpha frequency (8-12Hz)
timeFrame: Up to 25 days from T1 (T2)
measure: Alpha frequency (8-12Hz)
timeFrame: Up to 52 days from T1 (T3)
measure: Beta frequency (13-30Hz)
timeFrame: Day 1 (T1)
measure: Beta frequency (13-30Hz)
timeFrame: Up to 25 days from T1 (T2)
measure: Beta frequency (13-30Hz)
timeFrame: Up to 52 days from T1 (T3)
measure: Gamma frequency (>30Hz)
timeFrame: Day 1 (T1)
measure: Gamma frequency (>30Hz)
timeFrame: Up to 25 days from T1 (T2)
measure: Gamma frequency (>30Hz)
timeFrame: Up to 52 days from T1 (T3)
measure: Alexithymia score
timeFrame: Up to 16 days from T2
measure: Neuroticism score
timeFrame: Up to 16 days from T1
measure: Trait and state anxiety scores
timeFrame: Up to 8 days from T1
measure: Style of coping
timeFrame: Up to 16 days from T1
measure: Positive affectivity score
timeFrame: Day 1 (T1)
measure: Positive affectivity score
timeFrame: Up to 25 days from T1 (T2)
measure: Positive affectivity score
timeFrame: Up to 52 days from T1 (T3)
measure: Depressive symptoms score
timeFrame: Day 1 (T1)
measure: Depressive symptoms score
timeFrame: Up to 25 days from T1 (T2)
measure: Depressive symptoms score
timeFrame: Up to 52 days from T1 (T3)
measure: Perceived-stress level
timeFrame: Day 1 (T1)
measure: Perceived-stress level
timeFrame: Up to 25 days from T1 (T2)
measure: Perceived-stress level
timeFrame: Up to 52 days from T1 (T3)
measure: Coping flexibility
timeFrame: Day 1 (T1)
measure: Coping flexibility
timeFrame: Up to 25 days from T1 (T2)
measure: Coping flexibility
timeFrame: Up to 52 days from T1 (T3)
measure: Metacoping
timeFrame: Day 1 (T1)
measure: Metacoping
timeFrame: Up to 25 days from T1 (T2)
measure: Metacoping
timeFrame: Up to 52 days from T1 (T3)
measure: Social support score
timeFrame: Up to 8 days from T1
measure: Interceptive sensitivity score
timeFrame: Up to 8 days from T1
measure: Life satisfaction score
timeFrame: Day 1 (T1)
measure: Life satisfaction score
timeFrame: Up to 25 days from T1 (T2)
measure: Life satisfaction score
timeFrame: Up to 52 days from T1 (T3)
measure: Negative impact scores
timeFrame: Up to 16 days from T2
measure: Frequency, severity and intensity scores
timeFrame: Up to 8 days from T2
measure: Child Abuse scores
timeFrame: Up to 16 days from T1
measure: Acceptance score
timeFrame: Day 1 (T1)
measure: Acceptance score
timeFrame: Up to 25 days from T1 (T2)
measure: Acceptance score
timeFrame: Up to 52 days from T1 (T3)
Other outcomes:
Locations:
city: Grenoble
country: France
facility: University Hospital, Grenoble Alpes
state: Isère
Study officials:
affiliation: University Hospital, Grenoble
name: Bruno BONAZ, Pr
role: PRINCIPAL_INVESTIGATOR
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