Study on Neurofeedback and Relaxation (NEURORELAX)

National Center for Scientific Research (CNRS)

Status: Unknown

Conditions: Healthy People

Treatments: Behavioral: Alpha-based neurofeedback; Behavioral: Sham neurofeedback

Study type: Interventional

Funder types: Other

Identifiers

NCT04545359

17001

RCB 2017-A02786-47

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 2 patient groups

Neurofeedback Group

Experimental group

Description:

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.

Treatment:

Behavioral: Alpha-based neurofeedback

Control Group

Sham Comparator group

Description:

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.

Treatment:

Behavioral: Sham neurofeedback