EpilepsyEPIFEEDNCT07356661
Evaluation of the Efficacy of Neurofeedback Technique Based on EEG Desynchronization in Epileptic Patients
A study testing Neurofeedback in people with Epilepsy and Drug Resistant Epilepsy, run by Assistance Publique Hopitaux De Marseille.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Epilepsy, Drug Resistant Epilepsy
- What is being tested?
- Neurofeedback
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2026to 31 Oct 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 18 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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;
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- 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
Who cannot join
- - 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 :
- Subject presenting any neurological or psychiatric illnesses.
- Subject having major visual impairment incompatible with the realization of neurofeedback, based on investigator's opinion.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Fabrice Bartolomei contact
About this study
Official title: Randomized Double-blind Placebo-controlled Study of the Evaluation of the Efficacy of Neurofeedback Technique Based on EEG Desynchronization in Pharmaco-resistant Epilepsy
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.
Read more
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
- Being tested
- Neurofeedback, Sham-NFB
- Keywords
- epilepsy, neurofeedback, connectivity
- Medical subject headings
- Epilepsy, Drug Resistant Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeurofeedbackProcedure or surgery
Also called Questionnaires
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-NFBProcedure or surgery
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 group | Role | What they receive |
|---|---|---|
| NFB-FC | Experimental | Not described Receives: Procedure: Neurofeedback |
| Sham-NFB | Placebo comparator | Not described Receives: Procedure: Sham-NFB |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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)
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)
Measured: 3-months after the end of the training
To compare between groups the cognitive impact
EpiTrack evaluation
Measured: 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)
Measured: 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%
Measured: 3-months after the end of the training
To compare between groups the number of seizure-free patients
Number of patients free of seizures
Measured: 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)
Measured: 3-months after the end of the training
The impact of transfer skills
Use of the diary of seizures the Score of seizure severity
Measured: 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
Measured: 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
Measured: 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).
Measured: 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).
Measured: After each training sessions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2026
- Study start1 Mar 2026 (estimated)
- Primary completion30 Sep 2028 (estimated)
- Study completion31 Oct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07356661
- Sponsor's protocol ID
- RCAPHM22_0313
- Other IDs
- ID-RCB 2025-A00981-48
- Acronym
- EPIFEED
- Status last verified
- Dec 2025
- First submitted
- 27 Sep 2025
- Last updated
- 21 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Double-blind Placebo-controlled Study of the Evaluation of the Efficacy of Neurofeedback Technique Based on EEG Desynchronization in Pharmaco-resistant Epilepsy
- ClinicalTrials.gov ID
- NCT07356661
- Acronym / sponsor ID
- EPIFEED / RCAPHM22_0313
- Conditions
- Epilepsy, Drug Resistant Epilepsy
- Keywords
- epilepsy, neurofeedback, connectivity
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 1 Mar 2026 (estimated)
- Primary completion
- 30 Sep 2028 (estimated)
- Study completion
- 31 Oct 2029 (estimated)
- First posted
- 21 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NFB-FC | Experimental | Procedure: Neurofeedback |
| Sham-NFB | Placebo comparator | Procedure: Sham-NFB |
Who may qualify
- Ages
- 18 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- 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);
Key exclusion criteria (8 listed)
- - 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)).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NeurofeedbackAlso: QuestionnairesThe 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. | Procedure or surgery | NFB-FC |
| Sham-NFBThe 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. | Procedure or surgery | Sham-NFB |
Primary outcome
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
Comparison to the NFB-sham training calculated in the pre-training period of reference
11 secondary outcomes
To compare between groups the psychiatric impact (depression and anxiety)
Time frame: 3-months after the end of the training
To compare between groups the cognitive impact
Time frame: One year after inclusion
To compare between groups the quality of life
Time frame: 3-months after the end of the training to the pre-training period
To compare between groups the number of responders
Time frame: 3-months after the end of the training
To compare between groups the number of seizure-free patients
Time frame: 3-months after the end of the training
To compare between groups the change in seizure severity
Time frame: 3-months after the end of the training
The impact of transfer skills
Time frame: 6 weeks of applied learned strategies
To assess, in the whole sample and per group (sham, active), correlations between FC changes and clinical outcomes
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: After each training sessions
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Fabrice Bartolomei contact
Questions about this trial
What is this clinical trial studying?
A study testing Neurofeedback in people with Epilepsy and Drug Resistant Epilepsy, run by Assistance Publique Hopitaux De Marseille.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Angela Marchi (04 91 38 57 15 ext. 33, angela.marchi@ap-hm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2026.