Healthy PeopleNEURORELAXNCT04545359
Study on Neurofeedback and Relaxation
A study testing Alpha-based neurofeedback in people with Healthy People, run by Centre National de la Recherche Scientifique, France at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy People
- What is being tested?
- Alpha-based neurofeedback
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 12 Dec 2018to 15 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Centre de Neuro-Imagerie de recherche (CENIR), ICM
Paris, 75013
Nathalie George, DR, +33 1 57 27 43 79, nathalie.george@upmc.fr
About this study
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
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.
Read the 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
- Being tested
- Alpha-based neurofeedback, Sham neurofeedback
- Keywords
- Neurofeedback, Electroencephalography (EEG), Alpha rhythm, Relaxation, Melomind device, Longitudinal analysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alpha-based neurofeedbackBehavioural
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 neurofeedbackBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Sham neurofeedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
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.
Measured: 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.
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.
Measured: 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.
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.
Measured: 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.
Affective state measured by the Positive and Negative Affect Schedule (PANAS), before the 1st neurofeedback training session and after the last neurofeedback training session.
Measured: 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.
Subjective stress level measured by the Perceived Stress Scale (PSS), before the 1st neurofeedback training session and after the last neurofeedback training session.
Measured: 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.
Anxiety state level measured by the State-Trait Anxiety Inventory (State evaluation, STAI-YB) before and after every training session.
Measured: 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.
Subjective relaxation state measured by a visual analog scale before and after every training session.
Measured: 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.
Correlation between EEG power spectrum features and scores at behavioral questionnaires and scales, across training sessions.
Measured: 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.
EEG signal measured continuously during the 21 minutes of neurofeedback training, on every session; EEG power spectrum analysis between 0.5 and 45 Hz.
Measured: 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2020
- Study start12 Dec 2018
- Primary completion15 Sep 2021 (estimated)
- Study completion15 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy PeopleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre National de la Recherche Scientifique, France
- Sponsor type
- University, hospital or other
- Collaborators
- Sorbonne University, Paris Brain Institute (ICM), myBrain Technologies, Institut National de la Santé Et de la Recherche Médicale, France
- Responsible party
- Principal investigator, Philippe Fossati, Assistance Publique - Hôpitaux de Paris
- Investigators
- Philippe Fossati, Pr, Principal investigator, Equipe CIA, ICM GH Pitié-Salpêtrière 47 Bd de l'Hôpital 75651 Paris Cedex 13Nathalie George, Dr, Principal investigator, CNRS, CENIR MEG-EEG, ICMLaurent Hugueville, Principal investigator, CNRS, CENIR MEG-EEG, ICMJean-Yves Rotgé, Dr, MD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04545359
- Sponsor's protocol ID
- RCB 2017-A02786-47
- Other IDs
- 17001
- Acronym
- NEURORELAX
- Status last verified
- Sep 2020
- First submitted
- 30 Mar 2020
- Last updated
- 11 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04545359
- Acronym / sponsor ID
- NEURORELAX / RCB 2017-A02786-47
- Conditions
- Healthy People
- Keywords
- Neurofeedback, Electroencephalography (EEG), Alpha rhythm, Relaxation, Melomind device, Longitudinal analysis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Centre National de la Recherche Scientifique, FranceUniversity, hospital or other
- Collaborators
- Sorbonne University, Paris Brain Institute (ICM), myBrain Technologies, Institut National de la Santé Et de la Recherche Médicale, France
- Study start
- 12 Dec 2018 (actual)
- Primary completion
- 15 Sep 2021 (estimated)
- Study completion
- 15 Sep 2021 (estimated)
- First posted
- 11 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Neurofeedback Group | Experimental | Behavioral: Alpha-based neurofeedbackParticipants 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. |
| Control Group | Sham comparator | Behavioral: Sham neurofeedbackParticipants 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Alpha-based neurofeedbackTwelve 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. | Behavioural | Neurofeedback Group |
| Sham neurofeedbackTwelve 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. | Behavioural | Control Group |
Primary outcome
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.
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.
9 secondary outcomes
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.
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.
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)).
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)).
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)).
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.
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.
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).
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).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philippe Fossati, Pr principal investigator
Equipe CIA, ICM GH Pitié-Salpêtrière 47 Bd de l'Hôpital 75651 Paris Cedex 13
Nathalie George, Dr principal investigator
CNRS, CENIR MEG-EEG, ICM
Laurent Hugueville principal investigator
CNRS, CENIR MEG-EEG, ICM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alpha-based neurofeedback in people with Healthy People, run by Centre National de la Recherche Scientifique, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Philippe Fossati, Pr (+33 1 42 16 28 70, philippe.fossati@psl.aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2020.