Longitudinal Study of the Effects of Neurofeedback Training on the Level of Relaxation in Healthy Population: Characterization at the Electrophysiological and Behavioral Levels
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Healthy People
- Sponsor
- Centre National de la Recherche Scientifique, France
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Change in alpha frequency band power at the end of the 12 neurofeedback training sessions relative to the initial, pre-training, alpha power level.
- Last Updated
- 5 years ago
Overview
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.
Investigators
Philippe Fossati
University Professor and Hospital Practitioner in psychiatry
Assistance Publique - Hôpitaux de Paris
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
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- 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 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)).)
- Correlation between the changes in electrophysiological measurements and the changes in behavioral measures.(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.(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).)
- 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 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 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)).)
- Changes in anxiety state at post-training relative to pre-training across 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.(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.)