Neurovegetative Decoupling in Somatoform Disorders : Biofeedback Interest
- Conditions
- Psychogenic Non-Epileptic SeizureSomatoform DisordersIrritable Bowel Syndrome
- Interventions
- Behavioral: Heart rate variability Biofeedback [HRV-BFB]
- Registration Number
- NCT04807933
- Lead Sponsor
- University Hospital, Grenoble
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 46
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Experimental group (BFB training) Heart rate variability Biofeedback [HRV-BFB] 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).
- Primary Outcome Measures
Name Time Method Root mean square of successive RR interval differences [RMSSD] Up to 52 days from T1 (T3) Root mean square of successive RR interval differences, temporal-domain parameter
RMSSD will be measured using the electrocardiogram \[ECG\]:
ECG data will be recorded using 3 single use and adhesive electrodes placed on the inner side of the right wrist, on the right shoulder and on the left side in accordance with the DII standard position (Einthoven). Physiological data recorded are related to the heart rate variability \[HRV\].High frequency [HF] (0.15-0.40 Hz) Up to 52 days from T1 (T3) High frequency (0.15-0.40 Hz), frequency-domain parameter
HF will be measured using the electrocardiogram \[ECG\]:
ECG data will be recorded using 3 single use and adhesive electrodes placed on the inner side of the right wrist, on the right shoulder and on the left side in accordance with the DII standard position (Einthoven). Physiological data recorded are related to the heart rate variability \[HRV\].
- Secondary Outcome Measures
Name Time Method Breathing rate Up to 52 days from T1 (T3) Breathing rate by cycles per minute
The breathing rate will be measured using a breathing belt.Low frequency [LF] 0.1 Hertz (0.075-0.108Hz) Up to 52 days from T1 (T3) Spectral power of the low-frequency 0.1Hz band (0.075-0.108Hz), frequency-domain parameter
LF-0.1Hz will be measured using the electrocardiogram \[ECG\]:
ECG data will be recorded using 3 single use and adhesive electrodes placed on the inner side of the right wrist, on the right shoulder and on the left side in accordance with the DII standard position (Einthoven). Physiological data recorded are related to the heart rate variability \[HRV\].Gamma frequency (>30Hz) Up to 52 days from T1 (T3) Gamma frequency \>30 Hertz band
Gamma frequency will be measured using the electroencephalogram \[EEG\]:
EEG data will be recorded using a EEG headsets including 64 electrodes. The EEG is related to the brain activity generated by the neural functioning.Integrated skin conductance responses [ISCR] Up to 52 days from T1 (T3) Integrated skin conductance responses \[ISCR\]: area of the galvanic skin responses identified on the signal
ISCR will be measured using the Galvanic skin responses \[GSR\]:
GSR data will be recorded using 2 skin sensors placed on the third phalanx of the forefinger and of the middle finger of the left hand. Physiological data recorded are related to the cholinergic sympathetic activity (tonic GSR / phasic GSR).Standard deviation of all NN intervals [SDNN] Up to 52 days from T1 (T3) Standard deviation of all NN intervals, temporal-domain parameter
SDNN will be measured using the electrocardiogram \[ECG\]:
ECG data will be recorded using 3 single use and adhesive electrodes placed on the inner side of the right wrist, on the right shoulder and on the left side in accordance with the DII standard position (Einthoven). Physiological data recorded are related to the heart rate variability \[HRV\].Pulsatility index variation [PI] Up to 52 days from T1 (T3) Pulsatility index variation \[PI\] : transit time flow
PI will be measured using the Photoplethysmography \[PPG\]:
PPG data will be recorded using a finger sensor. Physiological data recorded are related to the adrenergic sympathetic tone and allowing a record of the blood pulse waves associated with the heart rate.Low frequency [LF] (0.04-0.15 Hz) Up to 52 days from T1 (T3) Low frequency (0.04-0.15 Hz), frequency-domain parameter
LF will be measured using the electrocardiogram \[ECG\]:
ECG data will be recorded using 3 single use and adhesive electrodes placed on the inner side of the right wrist, on the right shoulder and on the left side in accordance with the DII standard position (Einthoven). Physiological data recorded are related to the heart rate variability \[HRV\].Total power (0-0.40 Hz) Up to 52 days from T1 (T3) Total power of the 0-0.40 Hertz band, frequency-domain parameter
Total power will be measured using the electrocardiogram \[ECG\]:
ECG data will be recorded using 3 single use and adhesive electrodes placed on the inner side of the right wrist, on the right shoulder and on the left side in accordance with the DII standard position (Einthoven). Physiological data recorded are related to the heart rate variability \[HRV\].Ratio Low frequency / High frequency [LF / HF] Up to 52 days from T1 (T3) Ratio of LF to HF power, frequency-domain parameter
LF/HF will be measured using the electrocardiogram \[ECG\]:
ECG data will be recorded using 3 single use and adhesive electrodes placed on the inner side of the right wrist, on the right shoulder and on the left side in accordance with the DII standard position (Einthoven). Physiological data recorded are related to the heart rate variability \[HRV\].Skin conductance responses [SCR] frequency Up to 52 days from T1 (T3) Skin conductance responses \[SCR\] frequency : number of the spontaneous galvanic skin responses by periods
SCR will be measured using the Galvanic skin responses \[GSR\]:
GSR data will be recorded using 2 skin sensors placed on the third phalanx of the forefinger and of the middle finger of the left hand. Physiological data recorded are related to the cholinergic sympathetic activity (tonic GSR / phasic GSR).Dominant power (0-0.15Hz) Up to 52 days from T1 (T3) Dominant power of the 0-0.15 Hertz band, frequency-domain parameter
Dominant power will be measured using the electrogastrogram \[EGG\]:
EGG data will be recorded using 6 single use and adhesive electrodes placed on the skin of the abdomen.Total power (0-0.15Hz) Up to 52 days from T1 (T3) Total power of the 0-0.15 Hertz band, frequency-domain parameter
Total power will be measured using the electrogastrogram \[EGG\]:
EGG data will be recorded using 6 single use and adhesive electrodes placed on the skin of the abdomen.Alpha frequency (8-12Hz) Up to 52 days from T1 (T3) Alpha frequency 8-12 Hertz band
Alpha frequency will be measured using the electroencephalogram \[EEG\]:
EEG data will be recorded using a EEG headsets including 64 electrodes. The EEG is related to the brain activity generated by the neural functioning.Alexithymia score Up to 16 days from T2 Alexithymia score will be measured using the Bermond-Vorst Alexithymia Questionnaire B version (BVAQ-B; Vorst \& Bermond, 2001; French version Deborde et al., 2004). The subscale as considered as a trait scale including 20 items.
Neuroticism score Up to 16 days from T1 Neuroticism score will be measured using the Big Five Inventory-Neuroticism (BFI-N; John et al., 1991; French version Plaisant et al., 2005). The subscale as considered as a trait scale including 8 items.
Trait and state anxiety scores Up to 8 days from T1 The trai and state anxiety scores will be measured using the State-Trait Anxiety Inventory (STAI Y-AB) (Spielberger et al., 1983; French version Bruchon-Schweitzer \& Paulhan, 1990). The scale includes 40 items.
Perceived-stress level Up to 52 days from T1 (T3) The perceived-stress level will be measured using the Perceived Stress Scale (PSS; Cohen et al., 1983; French version Bellighausen et al., 2009). The subscale as considered as a state scale including 10 items.
Coping flexibility Up to 52 days from T1 (T3) The coping flexibility score will be measured using the Coping Flexibility Scale (CFS; Kato, 2012). The CFS measures the coping flexibility including 10 items. The subscale as considered as a state scale.
Skin conductance responses [SCR] amplitude Up to 52 days from T1 (T3) Skin conductance responses amplitude: amplitude of the spontaneous galvanic skin responses by periods
SCR will be measured using the Galvanic skin responses \[GSR\]:
GSR data will be recorded using 2 skin sensors placed on the third phalanx of the forefinger and of the middle finger of the left hand. Physiological data recorded are related to the cholinergic sympathetic activity (tonic GSR / phasic GSR).Slow-waves frequency (physiological outcome) Up to 52 days from T1 (T3) Slow-waves frequency per minute, frequency-domain parameter
Slow-wave frequency will be measured using the electrogastrogram \[EGG\]:
EGG data will be recorded using 6 single use and adhesive electrodes placed on the skin of the abdomen.Style of coping Up to 16 days from T1 The style of coping will be measured using the Brief Cope (Carver, 1997; French version Muller \& Spitz, 2003). We will use it in its trait version. The subscale as considered as a trait scale including 28 items.
Life satisfaction score Up to 52 days from T1 (T3) The life satisfaction score will be measured using the Satisfaction With Life Scale (SWLS; Diener et al., 1985; French version Blais et al., 1989). The subscale as considered as a state scale including 5 items.
Frequency, severity and intensity scores Up to 8 days from T2 The frequency, severity and intensity scores will be measured using the Daily Hassles Scale (DHS; Kanner et al., 1981). The subscale as considered as a trait scale including 117 items.
Delta frequency (0-4Hz) Up to 52 days from T1 (T3) Delta frequency 0-4 Hertz band
Delta frequency will be measured using the electroencephalogram \[EEG\]:
EEG data will be recorded using a EEG headsets including 64 electrodes. The EEG is related to the brain activity generated by the neural functioning.Positive affectivity score Up to 52 days from T1 (T3) Positive affectivity score will be measured using the Positive And Negative Affect Schedule (PANAS; Watson et al., 1988; French version Caci \& Bayle, 2007). To measure a global affective state, a score of positivity will be calculated by subtracting negative affect score from positive affect score. The subscale as considered as a state scale including 20 items.
Interceptive sensitivity score Up to 8 days from T1 The interceptive sensitivity score will be measured using the Multidimensional Assessment of Interoceptive Awareness second version (MAIA-2; Mehling et al., 2018). The subscale as considered as a trait scale including 37 items.
Acceptance score Up to 52 days from T1 (T3) The acceptance score will be measured using the Illness Cognition Questionnaire for chronic disease (ICQ-18; Evers et al., 2001). The subscale as considered as a state scale including 18 items.
Theta frequency (4-7Hz) Up to 52 days from T1 (T3) Theta frequency 4-7 Hertz band
Theta frequency will be measured using the electroencephalogram \[EEG\]:
EEG data will be recorded using a EEG headsets including 64 electrodes. The EEG is related to the brain activity generated by the neural functioning.Beta frequency (13-30Hz) Up to 52 days from T1 (T3) Beta frequency 13-30 Hertz band
Beta frequency will be measured using the electroencephalogram \[EEG\]:
EEG data will be recorded using a EEG headsets including 64 electrodes. The EEG is related to the brain activity generated by the neural functioning.Social support score Up to 8 days from T1 The social support score will be measured using the Social Support Questionnaire short version (SSQ6; Sarason et al., 1987a; French version Bruchon-Schweitzer et al., 2003). The subscale as considered as a trait scale including 6 items.
Depressive symptoms score Up to 52 days from T1 (T3) The depressive symptoms score will be measured using the Center for Epidemiologic Studies-Depression Scale (CES-D; Radloff, 1977; French version Führer \& Rouillon, 1989). The subscale as considered as a state scale including 20 items.
Metacoping Up to 52 days from T1 (T3) The metacoping score will be measured using a visual analogue scale (VAS). The VAS was developed by ourselves to measure the perceived effectiveness of coping by asking: " how strategies used by yourself to cope with the situation were efficient? ". The participants will have to rate from 0 (no efficacy) to 10 (maximum of efficacy). The subscale as considered as a state scale.
Negative impact scores Up to 16 days from T2 The negative impact score will be measured using the Life Experiences Survey (LES; Sarason et al., 1978). The subscale as considered as a trait scale including 50 items. In this study a modified version of the LES will be used, whereby subjects documented the presence and perceived impact of adulthood life events that had occurred since 18 years of age to the time of completion of the survey. For the purposes of this study, 3 scores will be generated from this survey: the number of negatively perceived life events, the negative impact score determined by the sum of the impact scores of negatively perceived life events alone (higher scores indicate greater negative impact), and the total impact score determined by the sum of the impact scores of both negatively and positively perceived life events (higher scores indicate an overall more positive impact and lower scores indicate an overall more negative impact of all adulthood life events).
Child Abuse scores Up to 16 days from T1 The child abuse scores will be measured using the Childhood Trauma Questionnaire-Short Form (CTQ; Bernstein et al., 2003). The subscale as considered as a trait scale including 28 items.
Trial Locations
- Locations (1)
University Hospital, Grenoble Alpes
🇫🇷Grenoble, Isère, France