The goal of this clinical trial is to to obtain a significant decrease in seizure frequency in patients with refractory focal epilepsy after applying treatment of cathodal tDCS, compared to sham stimulation drug-resistant epileptic patient. The main questions it aims to answer are:
* Changes in quality of life * Percent of newly reported side effects after the stimulation period * Scores in epilepsy severity. Participants will be randomized in a cross-over, and will receive 10 days of tDCS or Sham. Each day will allow 2 periods of 20 minutes stimulation separated by 20 minutes off (with 40 minutes of cathodal stimulation total).
Patient, parents or legal representative who have given written informed consent;
Age: ≥ 9 years;
Patients with drug-resistant focal epilepsy with no evolutive brain lesion and no surgical indication or with a previous surgical failure, refusing surgery or with a planned surgery compatible with the total duration of this study;
SEEG previously performed before inclusion with an adequate definition of the epileptogenic zone with all data required (pre-SEEG MRI, CT-scan or MRI with electrodes during SEEG and SEEG files) for personalization ;
Patients with seizures of generalized onset in the last 12 months;
Patient with multifocal epileptogenic zones, bilateral epileptogenic zone, or poorly defined epileptogenic zone. The epileptogenic network should not be restricted to the orbito frontal cortex or cingulate cortex;
Patients with psychogenic nonepileptic seizures;
Patient presenting a contraindication to MRI 3T (patient having a pacemaker, metallic foreign bodies, non-removably implanted electronic medical devices, claustrophobia, inability to remain in supine position, vagus nerve stimulator even when switched off is a contraindication for MRI 3T. EPINOV or NEURO 7T trial patients, who have accepted for their data to be reused, can be included even while wearing a VNS device) ;
Crossover
transcranial direct current stimulation
DeviceResearch MRI includes 3D-T1 weighted MRI (3D-T1), diffusion MRI (dMRI), resting-state functional MRI (rsfMRI).
To obtain a significant seizure frequency change at the end of tDCS sessions compared to the seizure frequency calculated in the pre-treatment period of reference.
Seizure frequency counting after end of tDCS treatment compared to the baseline comparing Sham versus Active arms of the cross-over study.
To obtain a significant seizure frequency change at the end of tDCS sessions compared to the seizure frequency calculated in the pre-treatment period of reference.
Seizure frequency counting after end of tDCS treatment compared to the baseline comparing Sham versus Active arms of the cross-over study.
To obtain a significant seizure frequency change at the end of tDCS sessions compared to the seizure frequency calculated in the pre-treatment period of reference.
Seizure frequency counting after end of tDCS treatment compared to the baseline comparing Sham versus Active arms of the cross-over study.
To obtain a significant seizure frequency change at the end of tDCS sessions compared to the seizure frequency calculated in the pre-treatment period of reference.
Seizure frequency counting after end of tDCS treatment compared to the baseline comparing Sham versus Active arms of the cross-over study.
Evaluation of the number of responders (defined as patient with >50% of seizure reduction)
Proportion of responders evaluated after active session of 10 days of tDCS treatment compared to the baseline comparing Sham versus Active arms of the cross-over study
Evaluation of the number of responders (defined as patient with >50% of seizure reduction)
Proportion of responders evaluated after active session of 10 days of tDCS treatment compared to the baseline comparing Sham versus Active arms of the cross-over study
Evaluation of the number of responders (defined as patient with >50% of seizure reduction)
Proportion of responders evaluated after active session of 10 days of tDCS treatment compared to the baseline comparing Sham versus Active arms of the cross-over study
Evaluation of the number of responders (defined as patient with >50% of seizure reduction)
Proportion of responders evaluated after active session of 10 days of tDCS treatment compared to the baseline comparing Sham versus Active arms of the cross-over study
Compare brain functional connectivity before and after tDCS treatment
Changes in functional connectivity measured by fMRI and EEG signal 4 weeks after the tDCS periods in comparison with baseline period
Evaluation of the impact of tDCS on interictal epileptic spikes (IESs)
Change in the number of IESs per time unit after each tDCS session in comparison with baseline period
Evaluation of the impact of tDCS on interictal epileptic spikes
Change in localization and extent of brain areas involved in IESs before and after each tDCS session in comparison with baseline period
Evaluation of the impact of tDCS on interictal epileptic spikes
Change in localization and extent of brain areas involved in IESs before and after each tDCS session in comparison with baseline period
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Assistance Publique Hopitaux De Marseille
Lead sponsor
CRMBM-CEMEREM
Collaborator
Institut National de la Santé Et de la Recherche Médicale, France
Collaborator
Neuroelectrics Corporation
Collaborator
