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.
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;
- 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
Sequential
Neurofeedback
Procedure/SurgeryThe 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/SurgeryThe 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.
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
To compare between groups the psychiatric impact (depression and anxiety)
Changes between groups of psychiatric comorbidities, specifically depression: score of the NDDI-E (Neurological Disorders Depression Inventory for Epilepsy, 6 to 24, 24 meaning bad outcome) and anxiety: Score of GAD-7 (between 0 and 21, 21 meaning bad outcome)
To compare between groups the cognitive impact
EpiTrack evaluation
To compare between groups the quality of life
QOLIE scale (Quality of Life in Epilepsy Inventory-Form 31, 0 to 100, 100 being the best outcome)
To compare between groups the number of responders
Patients showing a reduction in seizure frequency\>50%
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