Study on Neurofeedback and Relaxation

NCT ID: NCT04545359

Last Updated: 2020-09-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-12
• Study Completion Date: 2021-09-15

Brief 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.

Detailed Description

Despite a growing number of studies dedicated to neurofeedback, the underlying cerebral mechanisms (plasticity phenomena underlying neurofeedback training or learning) are very poorly known. In most of the work on stress and anxiety reduction, the neural parameters on which neurofeedback is performed are low frequency waves like alpha waves. But the effects that an alpha-based neurofeedback has on these waves and more generally on the oscillatory behaviour of the networks involved after the neurofeedback sessions, are very little studied.

Thus, the NEURORELAX study aims to clarify the effects on neurofeedback training at the (electro)physiological level (changes in brain responses in terms of frequency of oscillations, power and location of the cerebral sources of these activities) and/or behavioural level (relaxation and reduced susceptibility to anxiety). It will use the Melomind neurofeedback device as built by myBrain Technologies company, which will make it additionally possible to assess feasibility of neurofeedback training with this reduced mobile device comprising of 2 dry electrodes. For these purposes, the investigators will propose a series of auditory neurofeedback training sessions to the participants, accompanied by electrophysiological (EEG) and clinical measures. The level of relaxation of the subjects will be characterized by self-reported questionnaires and by electrophysiological signal measurement.

Conditions

Healthy People

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: TRIPLE

Study Groups

Neurofeedback Group

Participants from this group perform actual neurofeedback training, i.e they are instructed to control -- decrease -- in real-time a sound that is inversely related to the amplitude of their own alpha activity, obtained from Melomind EEG signals.

Group Type: EXPERIMENTAL

Alpha-based neurofeedback

Intervention Type: BEHAVIORAL

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.

Control Group

Participants from this group perform sham neurofeedback based on the feedback sounds generated by the participants from the Neurofeedback Group at the same step of the training program.

Group Type: SHAM_COMPARATOR

Sham neurofeedback

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Voluntary adult subjects, aged 18 to 60
• No known neurological history
• Having an anxiety level higher than 35 on the STAI-YA scale
• Insured under the French social security system
• Signature of the informed consent
• Absence of visual, hearing, sensory or motor deficits incompatible with participation in the study

Exclusion Criteria

• recreational use of psychotropic drugs
• ongoing anxiolytic / benzodiazepine treatment
• current depressive episode and/or generalized anxiety troubles
• person under guardianship, curatorship or safeguarding of justice or any other measure
• administrative or judicial deprivation of rights or liberty
• pregnant or breastfeeding
• unable to give consent
• person subject to a period of exclusion from further research

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sorbonne University

OTHER

Sponsor Role: collaborator

Institut du Cerveau et de la Moelle Epinière

UNKNOWN

Sponsor Role: collaborator

myBrain Technologies

UNKNOWN

Sponsor Role: collaborator

Institut National de la Santé Et de la Recherche Médicale, France

OTHER_GOV

Sponsor Role: collaborator

Centre National de la Recherche Scientifique, France

OTHER

Sponsor Role: lead

Responsible Party

Philippe Fossati

University Professor and Hospital Practitioner in psychiatry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Philippe Fossati, Pr

Role: PRINCIPAL_INVESTIGATOR

Equipe CIA, ICM GH Pitié-Salpêtrière 47 Bd de l'Hôpital 75651 Paris Cedex 13

Nathalie George, Dr

Role: PRINCIPAL_INVESTIGATOR

CNRS, CENIR MEG-EEG, ICM

Laurent Hugueville

Role: PRINCIPAL_INVESTIGATOR

CNRS, CENIR MEG-EEG, ICM

Jean-Yves Rotgé, Dr, MD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

Centre de Neuro-Imagerie de recherche (CENIR), ICM

Paris, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Philippe Fossati, Pr

Role: CONTACT

philippe.fossati@psl.aphp.fr

+33 1 42 16 28 70

Facility Contacts

Nathalie George, DR

Role: primary

nathalie.george@upmc.fr

+33 1 57 27 43 79

Other Identifiers

17001

Identifier Type: REGISTRY

Identifier Source: secondary_id

RCB 2017-A02786-47

Identifier Type: -

Identifier Source: org_study_id