Study on Neurofeedback and Relaxation

NCT04545359 | Unknown

• 2 other identifiers: RCB 2017-A02786-4717001
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy People

Keywords

Neurofeedback; Electroencephalography (EEG); Alpha rhythm; Relaxation; Melomind device; Longitudinal analysis

Outcome Measures

Primary Outcomes (2)

• Change in alpha frequency band power at the end of the 12 neurofeedback training sessions relative to the initial, pre-training, alpha power level.

  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.

  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 Outcomes (9)

• Change in the EEG power spectrum at the end of the 12 neurofeedback training sessions relative to the initial, pre-training, EEG spectral content.

  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.

  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.

  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.

  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.

  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)).

Study Arms (2)

Neurofeedback Group

EXPERIMENTAL

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.

Behavioral: Alpha-based neurofeedback

Control Group

SHAM COMPARATOR

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.

Behavioral: Sham neurofeedback

Interventions

Alpha-based neurofeedback 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.

Neurofeedback Group

Sham neurofeedback 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.

Control Group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre National de la Recherche Scientifique, France: lead
• Sorbonne University: collaborator
• Institut du Cerveau et de la Moelle Epinière: collaborator
• myBrain Technologies: collaborator
• Institut National de la Santé Et de la Recherche Médicale, France: collaborator

Study Sites (1)

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

Paris, 75013, France

RECRUITING

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Philippe Fossati, Pr

CONTACT

+33 1 42 16 28 70; philippe.fossati@psl.aphp.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: All the persons who may interact with the participants and/or implied in the analyses.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: University Professor and Hospital Practitioner in psychiatry

Model Details: There are two groups : one receives the real neurofeedback task and the second receives a sham neurofeedback. This study is double-blind randomized.

Study Record Dates

• First Submitted: March 30, 2020
• First Posted: September 11, 2020
• Study Start: December 12, 2018
• Primary Completion: September 15, 2021
• Study Completion: September 15, 2021
• Last Updated: September 11, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)