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

NCT07356661 | Not Yet Recruiting

• 2 other identifiers: RCAPHM22_0313ID-RCB 2025-A00981-48
• Study Type: interventional
• Target: 22
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Epilepsy; Drug Resistant Epilepsy

Keywords

epilepsy; neurofeedback; connectivity

Outcome Measures

Primary Outcomes (1)

• To evaluate the effect of NFB-FC training on seizure frequency

  Comparison to the NFB-sham training calculated in the pre-training period of reference

  3 months after the end of the training vs 3 months before training

Secondary Outcomes (11)

• To compare between groups the psychiatric impact (depression and anxiety)

  3-months after the end of the training

• To compare between groups the cognitive impact

  One year after inclusion

• To compare between groups the quality of life

  3-months after the end of the training to the pre-training period

• To compare between groups the number of responders

  3-months after the end of the training

• To compare between groups the number of seizure-free patients

  3-months after the end of the training

Study Arms (2)

NFB-FC

EXPERIMENTAL

Procedure: Neurofeedback

Sham-NFB

PLACEBO COMPARATOR

Procedure: Sham-NFB

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.

Also known as: Questionnaires

NFB-FC

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.

Sham-NFB

Eligibility Criteria

• Age: 18 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male or female patient between 18 and 65 years old
• Patient suffering from focal or multifocal drug-resistant epilepsy
• Patient having a number of seizures: at least 3 / month during the baseline
• Patient's IQ, which in the investigator's opinion will enable questionnaires and neuropsychological assessments to be carried out;
• Patient having stable medications for epilepsy 4 weeks before the baseline (except rescue treatment);
• Patient able to understand, speak and write in French;
• Patient willing to participate, and gave written consent to the study after receiving clear information
• Patient beneficiary or affiliated to a health insurance plan

You may not qualify if:

• \- Difficulty reading or understanding the French language or inability to understand information about the study
• Generalized epilepsy
• Major visual impairment incompatible with the realization of neurofeedback, based on investigator's opinion.
• Patient currently having psychogenic non-epileptic seizures
• Any condition that makes the study subject, in the opinion of the investigator, unsuitable for the study including presence of any disease, abnormality, medical or physical condition that, in the opinion of the investigator, may adversely impact, compromise, interfere, limit, affect or reduce the safety of the subject, the integrity of the data ; Person protected by articles L1121-5, L1121-6 of Public Health Code (pregnant or breastfeeding woman, deprived of liberty by judicial decision, situations of social fragility, adults unable or unable to express their consent, person under judicial safeguard (article L1122-2)).
• For healthy volunteers :
• Male or female of over 18 years of age
• IQ compatible with the realization of the study
• Patient able to understand, speak and write in French;
• Patient willing to participate, and gave written consent to the study after receiving clear information
• Subject beneficiary or affiliated to a health insurance plan
• Subject presenting any neurological or psychiatric illnesses.
• Subject having major visual impairment incompatible with the realization of neurofeedback, based on investigator's opinion.

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead

MeSH Terms

Conditions

Epilepsy; Drug Resistant Epilepsy

Interventions

Neurofeedback; Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Biofeedback, Psychology; Mind-Body Therapies; Complementary Therapies; Therapeutics; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Feedback, Psychological; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Central Study Contacts

Angela Marchi

CONTACT

04 91 38 57 15; angela.marchi@ap-hm.fr

Fabrice Bartolomei

CONTACT

fabrice.bartolomei@ap-hm.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2025
• First Posted: January 21, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): September 30, 2028
• Study Completion (Estimated): October 31, 2029
• Last Updated: January 21, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share