- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04545359
Study on Neurofeedback and Relaxation (NEURORELAX)
Longitudinal Study of the Effects of Neurofeedback Training on the Level of Relaxation in Healthy Population: Characterization at the Electrophysiological and Behavioral Levels
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Philippe Fossati, Pr
- Phone Number: +33 1 42 16 28 70
- Email: philippe.fossati@psl.aphp.fr
Study Locations
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-
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Paris, France, 75013
- Recruiting
- Centre de Neuro-Imagerie de recherche (CENIR), ICM
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Contact:
- Nathalie George, DR
- Phone Number: +33 1 57 27 43 79
- Email: nathalie.george@upmc.fr
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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.
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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.
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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)).
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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.
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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)).
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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)).
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Affective state measured by the Positive and Negative Affect Schedule (PANAS), before the 1st neurofeedback training session and after the last neurofeedback training session.
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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)).
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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)).
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Subjective stress level measured by the Perceived Stress Scale (PSS), before the 1st neurofeedback training session and after the last neurofeedback training session.
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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)).
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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.
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Anxiety state level measured by the State-Trait Anxiety Inventory (State evaluation, STAI-YB) before and after every training session.
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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.
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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.
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Subjective relaxation state measured by a visual analog scale before and after every training session.
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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.
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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).
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Correlation between EEG power spectrum features and scores at behavioral questionnaires and scales, across training sessions.
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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).
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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).
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EEG signal measured continuously during the 21 minutes of neurofeedback training, on every session; EEG power spectrum analysis between 0.5 and 45 Hz.
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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).
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Collaborators and Investigators
Collaborators
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
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- RCB 2017-A02786-47
- 17001 (REGISTRY: CNRS)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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