Study on Neurofeedback and Relaxation (NEURORELAX)

September 3, 2020 updated by: Philippe Fossati, Centre National de la Recherche Scientifique, France

Longitudinal Study of the Effects of Neurofeedback Training on the Level of Relaxation in Healthy Population: Characterization at the Electrophysiological and Behavioral Levels

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.

Study Overview

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.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

      • Paris, France, 75013
        • Recruiting
        • Centre de Neuro-Imagerie de recherche (CENIR), ICM
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 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.

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.

SHAM_COMPARATOR: 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.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in alpha frequency band power at the end of the 12 neurofeedback training sessions relative to the initial, pre-training, alpha power level.
Time Frame: From the 1st training session until the end of the 12th training session, the time frame of the assessment is 22 days minimum and 96 days maximum, with a minimum of 1 training session and a maximum of 3 training sessions per week.
Individual EEG power measures in alpha band (between 7 and 13 Hz), performed over several minutes at rest, pre- and post-training, on every session.
From the 1st training session until the end of the 12th training session, the time frame of the assessment is 22 days minimum and 96 days maximum, with a minimum of 1 training session and a maximum of 3 training sessions per week.
Change in alpha frequency band power at post-training relative to pre-training across every training session.
Time Frame: From the 1st training session until the end of the 12th training session, the time frame of the assessment is 22 days minimum and 96 days maximum, with a minimum of 1 training session and a maximum of 3 training sessions per week.
Individual EEG power measures in alpha band (between 7 and 13 Hz), performed over several minutes at rest, pre- and post-training, on every session.
From the 1st training session until the end of the 12th training session, the time frame of the assessment is 22 days minimum and 96 days maximum, with a minimum of 1 training session and a maximum of 3 training sessions per week.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in the EEG power spectrum at the end of the 12 neurofeedback training sessions relative to the initial, pre-training, EEG spectral content.
Time Frame: From the 1st training session until the end of the 12th training session, the time frame of the assessment is 22 days minimum and 96 days maximum, with a minimum of 1 training session and a maximum of 3 training sessions per week.
EEG signal measurement performed over several minutes at rest, pre- and post-training, on every session; EEG power spectrum analysis between 0.5 and 45 Hz.
From the 1st training session until the end of the 12th training session, the time frame of the assessment is 22 days minimum and 96 days maximum, with a minimum of 1 training session and a maximum of 3 training sessions per week.
Change in the EEG power spectrum at post-training relative to pre-training across every training session.
Time Frame: From the 1st training session until the end of the 12th training session, the time frame of the assessment is 22 days minimum and 96 days maximum, with a minimum of 1 training session and a maximum of 3 training sessions per week.
EEG signal measurement performed over several minutes at rest, pre- and post-training, on every session; EEG power spectrum analysis between 0.5 and 45 Hz.
From the 1st training session until the end of the 12th training session, the time frame of the assessment is 22 days minimum and 96 days maximum, with a minimum of 1 training session and a maximum of 3 training sessions per week.
Change in anxiety trait after the 12 neurofeedback training sessions relative to before the first training session.
Time Frame: Assessments are performed before the 1st training session (at day 1) and after the 12th training session (at day 22 up to 96, depending on the number of training sessions per week (1 minimum, 3 maximum)).
Anxiety trait level measured by the State-Trait Anxiety Inventory (Trait evaluation, STAI-YA), before the 1st neurofeedback training session and after the last neurofeedback training session.
Assessments are performed before the 1st training session (at day 1) and after the 12th training session (at day 22 up to 96, depending on the number of training sessions per week (1 minimum, 3 maximum)).
Change in affective state after the 12 neurofeedback training sessions relative to before the first training session.
Time Frame: Assessments are performed before the 1st training session (at day 1) and after the 12th training session (at day 22 up to 96, depending on the number of training sessions per week (1 minimum, 3 maximum)).
Affective state measured by the Positive and Negative Affect Schedule (PANAS), before the 1st neurofeedback training session and after the last neurofeedback training session.
Assessments are performed before the 1st training session (at day 1) and after the 12th training session (at day 22 up to 96, depending on the number of training sessions per week (1 minimum, 3 maximum)).
Change in stress level after the 12 neurofeedback training sessions relative to before the first training session.
Time Frame: Assessments are performed before the 1st training session (at day 1) and after the 12th training session (at day 22 up to 96, depending on the number of training sessions per week (1 minimum, 3 maximum)).
Subjective stress level measured by the Perceived Stress Scale (PSS), before the 1st neurofeedback training session and after the last neurofeedback training session.
Assessments are performed before the 1st training session (at day 1) and after the 12th training session (at day 22 up to 96, depending on the number of training sessions per week (1 minimum, 3 maximum)).
Changes in anxiety state at post-training relative to pre-training across every training session.
Time Frame: Assessments are performed before and after every training session; the estimated period of time of assessment is 22 days minimum and 96 days maximum, with a minimum of 1 training session and a maximum of 3 training sessions per week.
Anxiety state level measured by the State-Trait Anxiety Inventory (State evaluation, STAI-YB) before and after every training session.
Assessments are performed before and after every training session; the estimated period of time of assessment is 22 days minimum and 96 days maximum, with a minimum of 1 training session and a maximum of 3 training sessions per week.
Change in relaxation state at post-training relative to pre-training across every training session.
Time Frame: Assessments are performed before and after every training session; the estimated period of time of assessment is 22 days minimum and 96 days maximum, with a minimum of 1 training session and a maximum of 3 training sessions per week.
Subjective relaxation state measured by a visual analog scale before and after every training session.
Assessments are performed before and after every training session; the estimated period of time of assessment is 22 days minimum and 96 days maximum, with a minimum of 1 training session and a maximum of 3 training sessions per week.
Correlation between the changes in electrophysiological measurements and the changes in behavioral measures.
Time Frame: From the 1st training session until the 12th training session (minimum of 22 days and maximum of 96 days, with a minimum of 1 training session and a maximum of 3 training sessions per week).
Correlation between EEG power spectrum features and scores at behavioral questionnaires and scales, across training sessions.
From the 1st training session until the 12th training session (minimum of 22 days and maximum of 96 days, with a minimum of 1 training session and a maximum of 3 training sessions per week).
Changes in EEG power spectrum during the training sessions from the 1st until the 12th sessions.
Time Frame: From the 1st training session until the 12th training session (minimum of 22 days and maximum of 96 days, with a minimum of 1 training session and a maximum of 3 training sessions per week).
EEG signal measured continuously during the 21 minutes of neurofeedback training, on every session; EEG power spectrum analysis between 0.5 and 45 Hz.
From the 1st training session until the 12th training session (minimum of 22 days and maximum of 96 days, with a minimum of 1 training session and a maximum of 3 training sessions per week).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Philippe Fossati, Pr, Equipe CIA, ICM GH Pitié-Salpêtrière 47 Bd de l'Hôpital 75651 Paris Cedex 13
  • Principal Investigator: Nathalie George, Dr, CNRS, CENIR MEG-EEG, ICM
  • Principal Investigator: Laurent Hugueville, CNRS, CENIR MEG-EEG, ICM
  • Principal Investigator: Jean-Yves Rotgé, Dr, MD, Assistance Publique - Hôpitaux de Paris

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 12, 2018

Primary Completion (ANTICIPATED)

September 15, 2021

Study Completion (ANTICIPATED)

September 15, 2021

Study Registration Dates

First Submitted

March 30, 2020

First Submitted That Met QC Criteria

September 3, 2020

First Posted (ACTUAL)

September 11, 2020

Study Record Updates

Last Update Posted (ACTUAL)

September 11, 2020

Last Update Submitted That Met QC Criteria

September 3, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • RCB 2017-A02786-47
  • 17001 (REGISTRY: CNRS)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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