Evaluation of the Efficacy of Neurofeedback Technique Based on EEG Desynchronization in Epileptic Patients

Sponsor
Assistance Publique Hopitaux De Marseille
Study ID
NCT07356661
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 18 Years
Healthy Volunteers
Accepted

Interventions

  • Neurofeedback — PROCEDURE
    The intervention will consist of 12 training sessions at the hospital conducted with the assistance of a nurse. Each session will last approximately 40 minutes, with two resting EEG phases at the beginning and end of the session. The NFB procedure will consist of 6 training blocks of 75 seconds separated by 15-second rest blocks and 15-second baseline blocks. The patient will then be required to practice what they have learned at home.
  • Sham-NFB — PROCEDURE
    The intervention will consist of 12 training sessions at the hospital conducted with the assistance of a nurse. Each session will last approximately 40 minutes, with two resting EEG phases at the beginning and end of the session. The NFB procedure will consist of 6 training blocks of 75 seconds separated by 15-second rest blocks and 15-second baseline blocks. The patient will then be required to practice what they have learned at home.

Study Details

A large proportion of patients (approximately 30%) with drug-resistant epilepsy are not eligible for surgical treatment. The alternatives that can be offered to reduce the frequency of seizures are neuromodulation (vagus nerve stimulation (VNS), deep brain stimulation (DBS), or transcranial direct current stimulation (tDCS)). Most of these alternatives require invasive procedures and therefore carry risks. Neurofeedback (NFB) is a potential adjunctive treatment that allows patients to self-modulate brain activity and thus reduce seizure frequency in a non-invasive manner. This technique involves measuring neurophysiological activity using a technical interface to extract a parameter of interest, which is presented in real time to the participant, who has been trained and has learned how to modify it. NFB is of interest in various neurological and psychiatric diseases and can lead to improvement in mood disorders, which are frequently associated with epilepsy. Previous NFB methods in epilepsy aimed to modulate sensorimotor rhythms or slow cortical potentials. The investigators propose an innovative EEG-NFB paradigm based on real-time estimation of EEG functional connectivity (FC) measured on the scalp EEG (NFC-FC). This paradigm was developed based on previous studies demonstrating increased functional brain connectivity during the interictal period and decreased synchrony induced by VNS and transcranial electrical stimulation as a possible anti-epileptic mechanism. This study consists of a randomized, double-blind comparison between NFB-FC and sham-NFB (control). The effect of this functional connectivity-based NeuroFeedBack (NFB-FC) will be evaluated on the number of seizures before and after treatment, as well as on their severity and on criteria related to quality of life. In this study, two healthy volunteers will be recruited in order to generate the sham sessions.

Key Dates

First listed
Jan 21, 2026
Start date
Mar 1, 2026
Status verified
Dec 2025
Primary completion
Sep 30, 2028
Completion
Oct 31, 2029

Study Design

Enrollment
22 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: NFB-FC
  • Placebo Comparator: Sham-NFB

Primary Outcome Measure

To evaluate the effect of NFB-FC training on seizure frequency [ Time Frame: 3 months after the end of the training vs 3 months before training ]

Central Contacts

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