Neurovegetative Decoupling in Somatoform Disorders : Biofeedback Interest

NCT04807933 | Terminated DMC

• 1 other identifier: 2020-A02155-34
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (6)

• High frequency [HF] (0.15-0.40 Hz)

  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 \[HRV\].

  Day 1 (T1)

• High frequency [HF] (0.15-0.40 Hz)

  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 \[HRV\].

  Up to 25 days from T1 (T2)

• High frequency [HF] (0.15-0.40 Hz)

  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 \[HRV\].

  Up to 52 days from T1 (T3)

• Root mean square of successive RR interval differences [RMSSD]

  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 \[HRV\].

  Day 1 (T1)

• Root mean square of successive RR interval differences [RMSSD]

  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 \[HRV\].

  Up to 25 days from T1 (T2)

• Root mean square of successive RR interval differences [RMSSD]

  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 \[HRV\].

  Up to 52 days from T1 (T3)

Secondary Outcomes (84)

• Low frequency [LF] (0.04-0.15 Hz)

  Day 1 (T1)

• Low frequency [LF] (0.04-0.15 Hz)

  Up to 25 days from T1 (T2)

• Low frequency [LF] (0.04-0.15 Hz)

  Up to 52 days from T1 (T3)

• Low frequency [LF] 0.1 Hertz (0.075-0.108Hz)

  Day 1 (T1)

• Low frequency [LF] 0.1 Hertz (0.075-0.108Hz)

  Up to 25 days from T1 (T2)

Study Arms (2)

Experimental group (BFB training)

EXPERIMENTAL

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).

Behavioral: Heart rate variability Biofeedback [HRV-BFB]

Control group (no BFB training)

NO INTERVENTION

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

Interventions

Heart rate variability Biofeedback [HRV-BFB] BEHAVIORAL

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.

Also known as: Complementary technique

Experimental group (BFB training)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Grenoble: lead
• Laboratoire de Psychologie et NeuroCognition: collaborator
• Laboratoire interuniversitaire de psychologie - LIP-PC2S: collaborator

Study Sites (1)

University Hospital, Grenoble Alpes

Grenoble, Isère, 38700, France

Location

Related Publications (10)

• 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.

  PMID: 8598068 BACKGROUND

• 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.

  PMID: 28265249 BACKGROUND

• 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.

  PMID: 15029085 BACKGROUND

• 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.

  PMID: 30513087 BACKGROUND

• 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.

  PMID: 32235865 BACKGROUND

• 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.

  PMID: 29740350 BACKGROUND

• 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.

  PMID: 29787784 BACKGROUND

• 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.

  PMID: 31071705 BACKGROUND

• 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.

  PMID: 701572 BACKGROUND

• 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.

  PMID: 3397865 BACKGROUND

Related Links

• 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.
• Spielberger, C. D., Gorsuch, R. L., Luschene, R. E., Vagg, P. R., \& Jacobs, G. A. (1983). Manual for the state-trait anxiety inventory form Y. CA: Mind Garden Press.

MeSH Terms

Conditions

Somatoform Disorders; Irritable Bowel Syndrome; Psychogenic Nonepileptic Seizures; Wounds and Injuries

Condition Hierarchy (Ancestors)

Mental Disorders; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Seizures; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Bruno BONAZ, Pr

  University Hospital, Grenoble

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The participants won't be informed of the condition to which they belong. A debriefing will be done at the end of the last session (T3) for each participant.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pr. Bruno Bonaz

Model Details: 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).

Study Record Dates

• First Submitted: March 1, 2021
• First Posted: March 19, 2021
• Study Start: March 16, 2021
• Primary Completion: July 5, 2023
• Study Completion: September 5, 2023
• Last Updated: December 10, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)