NCT04545359

Study on Neurofeedback and Relaxation

Longitudinal Study of the Effects of Neurofeedback Training on the Level of Relaxation in Healthy Population: Characterization at the Electrophysiological and Behavioral Levels

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Centre National de la Recherche Scientifique, France · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy People

Interventions

Type	Name	Description
BEHAVIORAL	Alpha-based neurofeedback	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.
BEHAVIORAL	Sham neurofeedback	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.

Timeline

• Start date: 2018-12-12
• Primary completion: 2021-09-15
• Completion: 2021-09-15
• First posted: 2020-09-11
• Last updated: 2020-09-11

Locations

1 site across 1 country: France