Neurovegetative Decoupling in Somatoform Disorders : Biofeedback Interest
NCT ID: NCT04807933
Last Updated: 2024-12-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
46 participants
INTERVENTIONAL
2021-03-16
2023-09-05
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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Experimental group (BFB training)
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).
Heart rate variability Biofeedback [HRV-BFB]
BFB consists of a physiological recording used as a visual physiological feedback that can teach us how to control our physiology, which is naturally unconscious and uncontrollable. The BFB focused on the heart rate variability (HRV-BFB) could regulate the autonomic nervous system (vagal tone and sympathetic-parasympathetic balance) and the emotional state. The HRV BFB has received several clinical and experimental confirmations as a physiological remediation method. It is an innovative and non-pharmacological therapy frequently used to relieve stress.
Control group (no BFB training)
The participants assigned to the experimental group will not do a specific exercise during the intervention period (T2-T3).
No interventions assigned to this group
Interventions
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Heart rate variability Biofeedback [HRV-BFB]
BFB consists of a physiological recording used as a visual physiological feedback that can teach us how to control our physiology, which is naturally unconscious and uncontrollable. The BFB focused on the heart rate variability (HRV-BFB) could regulate the autonomic nervous system (vagal tone and sympathetic-parasympathetic balance) and the emotional state. The HRV BFB has received several clinical and experimental confirmations as a physiological remediation method. It is an innovative and non-pharmacological therapy frequently used to relieve stress.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
70 Years
ALL
No
Sponsors
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Laboratoire de Psychologie et NeuroCognition
OTHER
Laboratoire interuniversitaire de psychologie - LIP-PC2S
UNKNOWN
University Hospital, Grenoble
OTHER
Responsible Party
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Essaiclinique_BIOFEESOMATO
Pr. Bruno Bonaz
Principal Investigators
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Bruno BONAZ, Pr
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Grenoble
Locations
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University Hospital, Grenoble Alpes
Grenoble, Isère, France
Countries
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References
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Heart rate variability: standards of measurement, physiological interpretation and clinical use. Task Force of the European Society of Cardiology and the North American Society of Pacing and Electrophysiology. Circulation. 1996 Mar 1;93(5):1043-65. No abstract available.
Laborde S, Mosley E, Thayer JF. Heart Rate Variability and Cardiac Vagal Tone in Psychophysiological Research - Recommendations for Experiment Planning, Data Analysis, and Data Reporting. Front Psychol. 2017 Feb 20;8:213. doi: 10.3389/fpsyg.2017.00213. eCollection 2017.
Muller L, Spitz E. [Multidimensional assessment of coping: validation of the Brief COPE among French population]. Encephale. 2003 Nov-Dec;29(6):507-18. French.
Mehling WE, Acree M, Stewart A, Silas J, Jones A. The Multidimensional Assessment of Interoceptive Awareness, Version 2 (MAIA-2). PLoS One. 2018 Dec 4;13(12):e0208034. doi: 10.1371/journal.pone.0208034. eCollection 2018.
Varon C, Morales J, Lazaro J, Orini M, Deviaene M, Kontaxis S, Testelmans D, Buyse B, Borzee P, Sornmo L, Laguna P, Gil E, Bailon R. A Comparative Study of ECG-derived Respiration in Ambulatory Monitoring using the Single-lead ECG. Sci Rep. 2020 Mar 31;10(1):5704. doi: 10.1038/s41598-020-62624-5.
de Vroege L, Emons WHM, Sijtsma K, van der Feltz-Cornelis CM. Psychometric Properties of the Bermond-Vorst Alexithymia Questionnaire (BVAQ) in the General Population and a Clinical Population. Front Psychiatry. 2018 Apr 23;9:111. doi: 10.3389/fpsyt.2018.00111. eCollection 2018.
Bulut NS, Wurz A, Yorguner Kupeli N, Carkaxhiu Bulut G, Sungur MZ. Heart rate variability response to affective pictures processed in and outside of conscious awareness: Three consecutive studies on emotional regulation. Int J Psychophysiol. 2018 Jul;129:18-30. doi: 10.1016/j.ijpsycho.2018.05.006. Epub 2018 May 19.
Schumann A, Kohler S, Brotte L, Bar KJ. Effect of an eight-week smartphone-guided HRV-biofeedback intervention on autonomic function and impulsivity in healthy controls. Physiol Meas. 2019 Jul 1;40(6):064001. doi: 10.1088/1361-6579/ab2065.
Sarason IG, Johnson JH, Siegel JM. Assessing the impact of life changes: development of the Life Experiences Survey. J Consult Clin Psychol. 1978 Oct;46(5):932-46. doi: 10.1037//0022-006x.46.5.932. No abstract available.
Watson D, Clark LA, Tellegen A. Development and validation of brief measures of positive and negative affect: the PANAS scales. J Pers Soc Psychol. 1988 Jun;54(6):1063-70. doi: 10.1037//0022-3514.54.6.1063.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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Vorst, Harrie C.M, et Bob Bermond. " Validity and Reliability of the Bermond-Vorst Alexithymia Questionnaire ". Personality and Individual Differences 30, no 3 (février 2001): 413 34.
Plaisant O, Srivastava S, Mendelsohn GA, Debray Q, John OP. Relations entre le Big Five Inventory franc¸ais et le manuel diagnostique des troubles mentaux dans un échantillon clinique franc¸ais. Ann Med Psychol 2005;163:161-7.
Radloff LS. The CES-D scale: a self report depression scalefor research in the general population. App Psycho Meas1977;1:384-401.
Other Identifiers
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2020-A02155-34
Identifier Type: -
Identifier Source: org_study_id