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| ID | Type | Description | Link |
|---|---|---|---|
| ID-RCB 2025-A00981-48 | Other Identifier | ANSM |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NFB-FC | Experimental |
| |
| Sham-NFB | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 3-months after the end of the training |
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For patients :
Inclusion Criteria:
Exclusion Criteria:
For healthy volunteers :
Inclusion criteria :
Exclusion criteria :
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Angela Marchi | Contact | 04 91 38 57 15 | 33 | angela.marchi@ap-hm.fr |
| Fabrice Bartolomei | Contact | fabrice.bartolomei@ap-hm.fr |
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| ID | Term |
|---|---|
| D004827 | Epilepsy |
| D000069279 | Drug Resistant Epilepsy |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D058765 | Neurofeedback |
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D001676 | Biofeedback, Psychology |
| D026441 | Mind-Body Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
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|
| 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. |
|
| To compare between groups the cognitive impact | EpiTrack evaluation | One year after inclusion |
| 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) | 3-months after the end of the training to the pre-training period |
| To compare between groups the number of responders | Patients showing a reduction in seizure frequency>50% | 3-months after the end of the training |
| To compare between groups the number of seizure-free patients | Number of patients free of seizures | 3-months after the end of the training |
| To compare between groups the change in seizure severity | Score of seizure severity (NHS3, National Hospital Seizure Severity Scale, 1 to 27, 27 being the worst outcome) | 3-months after the end of the training |
| The impact of transfer skills | Use of the diary of seizures the Score of seizure severity | 6 weeks of applied learned strategies |
| To assess, in the whole sample and per group (sham, active), correlations between FC changes and clinical outcomes | Comparison of coherence values between the first recording (before the first session) and the last recording (after the last session) between responders and non-responders | At the end of the training and at 3 months after the end of the training |
| To assess, in the whole sample and per group (sham, active), correlations between FC changes and clinical outcomes | Comparison of coherence values between the first recording (before the first session) and the last recording (after the last session) between responders and non-responders | At 3 months after the end of the training |
| To assess, in the whole sample and per group (sham, active), neurophysiological correlations, psychosocial factors and mental strategies and clinical outcomes. | Score of mindfulness (FMI-fr); the Score of subjective cognitive state during NFB (NExT-Q), the Score of expectation and locus of control (Exp-LoC-Q),the Score of metacognition (Metacogn-IQ) and clinical outcome (seizure frequency, severity of seizures). | At 3 months after the end of the training |
| To assess, in the whole sample and per group (sham, active), neurophysiological correlations, psychosocial factors and mental strategies and clinical outcomes. | Score of mindfulness (FMI-fr); the Score of subjective cognitive state during NFB (NExT-Q), the Score of expectation and locus of control (Exp-LoC-Q),the Score of metacognition (Metacogn-IQ) and clinical outcome (seizure frequency, severity of seizures). | After each training sessions |
| D001521 |
| Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
| D030141 | Feedback, Psychological |
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |