Clinical trial NCT04545359: Study on Neurofeedback and Relaxation
Official title: Longitudinal Study of the Effects of Neurofeedback Training on the Level of Relaxation in Healthy Population: Characterization at the Electrophysiological and Behavioral Levels
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Healthy People
Keywords: Neurofeedback
Electroencephalography (EEG)
Alpha rhythm
Relaxation
Melomind device
Longitudinal analysis
Lead sponsor: Centre National de la Recherche Scientifique, France
Sponsor class: OTHER
Collaborators: name: Sorbonne University
name: Institut du Cerveau et de la Moelle Epinière
name: myBrain Technologies
name: Institut National de la Santé Et de la Recherche Médicale, France
First posted: 2020-09-11
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: There are two groups : one receives the real neurofeedback task and the second receives a sham neurofeedback.

This study is double-blind randomized.
Primary purpose: BASIC_SCIENCE

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.

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

Primary outcomes:
measure: Change in alpha frequency band power at the end of the 12 neurofeedback training sessions relative to the initial, pre-training, alpha power level.
timeFrame: 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.
measure: Change in alpha frequency band power at post-training relative to pre-training across every training session.
timeFrame: 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:
measure: Change in the EEG power spectrum at the end of the 12 neurofeedback training sessions relative to the initial, pre-training, EEG spectral content.
timeFrame: 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.
measure: Change in the EEG power spectrum at post-training relative to pre-training across every training session.
timeFrame: 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.
measure: Change in anxiety trait after the 12 neurofeedback training sessions relative to before the first training session.
timeFrame: 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)).
measure: Change in affective state after the 12 neurofeedback training sessions relative to before the first training session.
timeFrame: 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)).
measure: Change in stress level after the 12 neurofeedback training sessions relative to before the first training session.
timeFrame: 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)).
measure: Changes in anxiety state at post-training relative to pre-training across every training session.
timeFrame: 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.
measure: Change in relaxation state at post-training relative to pre-training across every training session.
timeFrame: 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.
measure: Correlation between the changes in electrophysiological measurements and the changes in behavioral measures.
timeFrame: 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).
measure: Changes in EEG power spectrum during the training sessions from the 1st until the 12th sessions.
timeFrame: 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).
Other outcomes:
Locations:
city: Paris
country: France
facility: Centre de Neuro-Imagerie de recherche (CENIR), ICM
Study officials:
affiliation: Equipe CIA, ICM GH Pitié-Salpêtrière 47 Bd de l'Hôpital 75651 Paris Cedex 13
name: Philippe Fossati, Pr
role: PRINCIPAL_INVESTIGATOR
affiliation: CNRS, CENIR MEG-EEG, ICM
name: Nathalie George, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: CNRS, CENIR MEG-EEG, ICM
name: Laurent Hugueville
role: PRINCIPAL_INVESTIGATOR
affiliation: Assistance Publique - Hôpitaux de Paris
name: Jean-Yves Rotgé, Dr, MD
role: PRINCIPAL_INVESTIGATOR
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