protocolSection identificationModule nctId: NCT06334952, orgStudyIdInfo id: RCAPHM23_0074, secondaryIdInfos id: ID-RCB, type: OTHER, domain: 2023-A02482-43, briefTitle: Efficacy of Personnalized Transcranial Direct Current Electrical Stimulation (tDCS) in Drug-resistant Epileptic, acronym: GALVANI GS-3, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-01, primaryCompletionDateStruct date: 2026-05-31, completionDateStruct date: 2027-04-30, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: Assistance Publique Hopitaux De Marseille, class: OTHER, collaborators name: CRMBM-CEMEREM, collaborators name: Institut National de la Santé Et de la Recherche Médicale, France - LTSI, collaborators name: Neuroelectrics Corporation, descriptionModule briefSummary: 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)., conditionsModule conditions: Epilepsy, conditions: Drug Resistant Epilepsy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: transcranial direct current stimulation, outcomesModule primaryOutcomes measure: 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., primaryOutcomes measure: 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., primaryOutcomes measure: 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., primaryOutcomes measure: 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., secondaryOutcomes measure: Evaluation of the number of responders (defined as patient with >50% of seizure reduction), secondaryOutcomes measure: Evaluation of the number of responders (defined as patient with >50% of seizure reduction), secondaryOutcomes measure: Evaluation of the number of responders (defined as patient with >50% of seizure reduction), secondaryOutcomes measure: Evaluation of the number of responders (defined as patient with >50% of seizure reduction), secondaryOutcomes measure: Evaluate the number of seizure-free patients, secondaryOutcomes measure: Evaluate the number of seizure-free patients, secondaryOutcomes measure: Evaluate the number of seizure-free patients, secondaryOutcomes measure: Evaluate the number of seizure-free patients, secondaryOutcomes measure: Quality of life after stimulation sessions with the baseline period, secondaryOutcomes measure: Quality of life after stimulation sessions with the baseline period, secondaryOutcomes measure: Quality of life after stimulation sessions with the baseline period, secondaryOutcomes measure: Quality of life after stimulation sessions with the baseline period, secondaryOutcomes measure: Evaluation of the change in seizure severity, secondaryOutcomes measure: Evaluation of the change in seizure severity, secondaryOutcomes measure: Evaluation of the change in seizure severity, secondaryOutcomes measure: Evaluation of the change in seizure severity, secondaryOutcomes measure: Changes in psychiatric comorbidities, secondaryOutcomes measure: Changes in psychiatric comorbidities, secondaryOutcomes measure: Changes in psychiatric comorbidities, secondaryOutcomes measure: Changes in psychiatric comorbidities, secondaryOutcomes measure: Safety assessment and possible side effects, secondaryOutcomes measure: Safety assessment and possible side effects, secondaryOutcomes measure: Safety assessment and possible side effects, secondaryOutcomes measure: Safety assessment and possible side effects, otherOutcomes measure: Compare brain functional connectivity before and after tDCS treatment, otherOutcomes measure: Evaluation of the impact of tDCS on interictal epileptic spikes (IESs), otherOutcomes measure: Evaluation of the impact of tDCS on interictal epileptic spikes, otherOutcomes measure: Evaluation of the impact of tDCS on interictal epileptic spikes, otherOutcomes measure: Evaluation of the impact of tDCS on interictal epileptic spikes, otherOutcomes measure: Evaluation of the impact of tDCS on interictal epileptic spikes, eligibilityModule sex: ALL, minimumAge: 9 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Service de Neurophysiologie Clinique de l'Enfant et de L'Adulte, Pôle de Neurosciences Cliniques, city: Bordeaux, zip: 33000, country: France, contacts name: Jerome Aupy, role: CONTACT, email: Jerome.aupy@chu-bordeaux.fr, geoPoint lat: 44.84044, lon: -0.5805, locations facility: Département Neurologie Fonctionnelle et Epilepsie, Hôpital neurologique - Hospices Civils de Lyon, city: Bron, zip: 69677, country: France, contacts name: Sylvain Rheims, role: CONTACT, email: Sylvain.rheims@chu-lyon.fr, geoPoint lat: 45.73333, lon: 4.91667, locations facility: Service de Neurophysiologie clinique - Hôpital Roger Salengro, CHU Lille, city: Lille, zip: 59037, country: France, contacts name: Philippe Derambure, role: CONTACT, email: Philippe.Derambure@chru-lille.fr, geoPoint lat: 50.63297, lon: 3.05858, locations facility: Service Epileptologie et Rythmologie Cérébrale, Hôpital La Timone, city: Marseille, zip: 13005, country: France, contacts name: Fabrice Bartolomei, role: CONTACT, email: Fabrice.bartolomei@ap-hm.fr, geoPoint lat: 43.29551, lon: 5.38958, locations facility: Service de Neurophysiologie clinique - GHU Psychiatrie et Neurosciences Sainte-Anne, city: Paris, zip: 75014, country: France, contacts name: Martine Gavaret, role: CONTACT, email: m.gavaret@ghu-paris.fr, geoPoint lat: 48.85341, lon: 2.3488, locations facility: Service de Neurologie - CHU de Rennes - Hôpital Pontchaillou, city: Rennes, zip: 35033, country: France, contacts name: Anca Nica, role: CONTACT, email: Anca.nica@chu-rennes.fr, geoPoint lat: 48.11198, lon: -1.67429, locations facility: Explorations neurophysiologiques - Pôle neurosciences, CHU de Toulouse, Hôpital Pierre Paul Riquet, city: Toulouse, zip: 31059, country: France, contacts name: Luc Valton, role: CONTACT, email: valton.l@chu-toulouse.fr, geoPoint lat: 43.60426, lon: 1.44367, hasResults: False