Study on Neurofeedback and Relaxation
NCT04545359 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60
Last updated 2020-09-11
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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