NCT07356661Not yet recruiting
Evaluation of the Efficacy of Neurofeedback Technique Based on EEG Desynchronization in Epileptic Patients
Randomized Double-blind Placebo-controlled Study of the Evaluation of the Efficacy of Neurofeedback Technique Based on EEG Desynchronization in Pharmaco-resistant Epilepsy
Source: ClinicalTrials.gov · Last updated 21 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 22 (estimated)
- First submitted
- 27 Sept 2025
- Start date
- 1 Mar 2026
- Primary completion date
- 30 Sept 2028
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Diseases
- Epilepsy
- NCT number
- NCT07356661
What you commit to
- Study type: Interventional
- Planned participants: 22
- From 1 Mar 2026 to the primary completion date, 30 Sept 2028
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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 :
- Subject presenting any neurological or psychiatric illnesses.
- Subject having major visual impairment incompatible with the realization of neurofeedback, based on investigator's opinion.
Other
- \- Difficulty reading or understanding the French language or inability to understand information about the study
Who the study is looking for
- 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
- 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
Criteria the registry did not label
- For patients :
Age in the registry: 18 years to 18 years · Sex: All · Accepts healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.