Study on Neurofeedback and Relaxation

NCT04545359 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2020-09-11

No results posted yet for this study

Summary

This longitudinal study deals with the characterization of the electrophysiological and behavioral effects of alpha-based neurofeedback training on the brain networks involved in the relaxation process of healthy people.

Conditions

  • Healthy People

Interventions

BEHAVIORAL

Alpha-based neurofeedback

Twelve 21-minute sessions (minimum of 1 session and maximum of 3 sessions per week) of auditory alpha-based neurofeedback with the Melomind device developed by myBrain Technologies (France). Recording of felt relaxation, perceived stress level, anxiety level pre-post sessions. Electrophysiological: Recording of EEG signals on 32 electrodes every two sessions.

BEHAVIORAL

Sham neurofeedback

Twelve 21-minute sessions (minimum of 1 session and maximum of 3 sessions per week) of an auditory sham neurofeedback with the Melomind device developed by myBrain Technologies (France). Sham feedback is based on the real feedback of the participants in the Experimental arm. Recording of felt relaxation, perceived stress level, anxiety level pre-post sessions. Electrophysiological: Recording of EEG signals on 32 electrodes every two sessions.

Sponsors & Collaborators

  • Sorbonne University

    collaborator OTHER
  • Institut du Cerveau et de la Moelle Epinière

    collaborator UNKNOWN
  • myBrain Technologies

    collaborator UNKNOWN
  • Institut National de la Santé Et de la Recherche Médicale, France

    collaborator OTHER_GOV
  • Centre National de la Recherche Scientifique, France

    lead OTHER

Principal Investigators

  • Philippe Fossati, Pr · Equipe CIA, ICM GH Pitié-Salpêtrière 47 Bd de l'Hôpital 75651 Paris Cedex 13

  • Nathalie George, Dr · CNRS, CENIR MEG-EEG, ICM

  • Laurent Hugueville · CNRS, CENIR MEG-EEG, ICM

  • Jean-Yves Rotgé, Dr, MD · Assistance Publique - Hôpitaux de Paris

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-12-12
Primary Completion
2021-09-15
Completion
2021-09-15

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04545359 on ClinicalTrials.gov