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| ID | Type | Description | Link |
|---|---|---|---|
| ID-RCB | Other Identifier | 2023-A02482-43 |
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| Name | Class |
|---|---|
| CRMBM-CEMEREM | UNKNOWN |
| Institut National de la Santé Et de la Recherche Médicale, France | OTHER_GOV |
| Neuroelectrics Corporation | INDUSTRY |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| tDCS - Sham | Other | Patient will be randomized to firstly receive tDCS (10 non consecutive days, 20 minutes twice a day with 20 minutes of break) and then Sham (10 non consecutive days, 20 minutes twice a day with 20 minutes of break). |
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| Sham - tDCS | Other | Patient will be randomized to firstly receive Sham (10 non consecutive days, 20 minutes twice a day with 20 minutes of break) and then tDCS (10 non consecutive days, 20 minutes twice a day with 20 minutes of break). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| transcranial direct current stimulation | Device | Research MRI includes 3D-T1 weighted MRI (3D-T1), diffusion MRI (dMRI), resting-state functional MRI (rsfMRI). |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Visit 4 (V4) - 4 weeks after the end of first cycle (each cycle is 10 days) |
| 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. | V5 - 8 weeks after the end of first cycle (each cycle is 10 days) |
| 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. | V7 - 4 weeks after the end of the second cycle (each cycle is 10 days) |
| 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. | V8 - 8 weeks after the end of the second cycle (each cycle is 10 days) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Visit 4 (V4) - 4 weeks after the end of first cycle (each cycle is 10 days) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | V5 - 8 weeks after the end of first cycle (each cycle is 10 days) |
| Evaluation of the impact of tDCS on interictal epileptic spikes (IESs) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fabrice Bartolomei, MD, PhD | Contact | 0491384990 | 33 | fabrice.bartolomei@ap-hpm.fr |
| Sophie Tardoski | Contact | 0491381594 | 33 | sophie.tardoski@ap-hm.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Service de Neurophysiologie Clinique de l'Enfant et de L'Adulte, Pôle de Neurosciences Cliniques | Recruiting | Bordeaux | 33000 | France |
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| 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 |
| V5 - 8 weeks after the end of first cycle (each cycle is 10 days) |
| 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 | V7 - 4 weeks after the end of the second cycle (each cycle is 10 days) |
| 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 | V8 - 8 weeks after the end of the second cycle (each cycle is 10 days) |
| Evaluate the number of seizure-free patients | Number of seizure-free patients after active session of 10 days of tDCS treatment compared to the baseline comparing Sham versus Active arms of the cross-over study | Visit 4 (V4) - 4 weeks after the end of first cycle (each cycle is 10 days) |
| Evaluate the number of seizure-free patients | Number of seizure-free patients after active session of 10 days of tDCS treatment compared to the baseline comparing Sham versus Active arms of the cross-over study | V5 - 8 weeks after the end of first cycle (each cycle is 10 days) |
| Evaluate the number of seizure-free patients | Number of seizure-free patients after active session of 10 days of tDCS treatment compared to the baseline comparing Sham versus Active arms of the cross-over study | V7 - 4 weeks after the end of the second cycle (each cycle is 10 days) |
| Evaluate the number of seizure-free patients | Number of seizure-free patients after active session of 10 days of tDCS treatment compared to the baseline comparing Sham versus Active arms of the cross-over study | V8 - 8 weeks after the end of the second cycle (each cycle is 10 days) |
| Quality of life after stimulation sessions with the baseline period | Changes from baseline in the quality of life questionnaire (QOLIE 31 for adults and EFIQUACEE QOL for children) after the stimulation period | Visit 4 (V4) - 4 weeks after the end of first cycle (each cycle is 10 days) |
| Quality of life after stimulation sessions with the baseline period | Changes from baseline in the quality of life questionnaire (QOLIE 31 for adults and EFIQUACEE QOL for children) after the stimulation period | V5 - 8 weeks after the end of first cycle (each cycle is 10 days) |
| Quality of life after stimulation sessions with the baseline period | Changes from baseline in the quality of life questionnaire (QOLIE 31 for adults and EFIQUACEE QOL for children) after the stimulation period | V7 - 4 weeks after the end of the second cycle (each cycle is 10 days) |
| Quality of life after stimulation sessions with the baseline period | Changes from baseline in the quality of life questionnaire (QOLIE 31 for adults and EFIQUACEE QOL for children) after the stimulation period | V8 - 8 weeks after the end of the second cycle (each cycle is 10 days) |
| Evaluation of the change in seizure severity | Changes in the scores of epilepsy severity (NHS3) (investigator evaluation) | Visit 4 (V4) - 4 weeks after the end of first cycle (each cycle is 10 days) |
| Evaluation of the change in seizure severity | Changes in the scores of epilepsy severity (NHS3) (investigator evaluation) | V5 - 8 weeks after the end of first cycle (each cycle is 10 days) |
| Evaluation of the change in seizure severity | Changes in the scores of epilepsy severity (NHS3) (investigator evaluation) | V7 - 4 weeks after the end of the second cycle (each cycle is 10 days) |
| Evaluation of the change in seizure severity | Changes in the scores of epilepsy severity (NHS3) (investigator evaluation) | V8 - 8 weeks after the end of the second cycle (each cycle is 10 days) |
| Changes in psychiatric comorbidities | Changes from baseline in depression (NDDI-E) and anxiety (GAD-7) scores | Visit 4 (V4) - 4 weeks after the end of first cycle (each cycle is 10 days) |
| Changes in psychiatric comorbidities | Changes from baseline in depression (NDDI-E) and anxiety (GAD-7) scores | V5 - 8 weeks after the end of first cycle (each cycle is 10 days) |
| Changes in psychiatric comorbidities | Changes from baseline in depression (NDDI-E) and anxiety (GAD-7) scores | V7 - 4 weeks after the end of the second cycle (each cycle is 10 days) |
| Changes in psychiatric comorbidities | Changes from baseline in depression (NDDI-E) and anxiety (GAD-7) scores | V8 - 8 weeks after the end of the second cycle (each cycle is 10 days) |
| Safety assessment and possible side effects | Percent of newly reported side-effect during and after the stimulation period | Visit 4 (V4) - 4 weeks after the end of first cycle (each cycle is 10 days) |
| Safety assessment and possible side effects | Percent of newly reported side-effect during and after the stimulation period | V5 - 8 weeks after the end of first cycle (each cycle is 10 days) |
| Safety assessment and possible side effects | Percent of newly reported side-effect during and after the stimulation period | V7 - 4 weeks after the end of the second cycle (each cycle is 10 days) |
| Safety assessment and possible side effects | Percent of newly reported side-effect during and after the stimulation period | V8 - 8 weeks after the end of the second cycle (each cycle is 10 days) |
Change in the number of IESs per time unit after each tDCS session in comparison with baseline period |
| Visit 4 (V4) - 4 weeks after the end of first cycle (each cycle is 10 days) |
| 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 | Visit 4 (V4) - 4 weeks after the end of first cycle (each cycle is 10 days) |
| 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 | V7 - 4 weeks after the end of the second cycle (each cycle is 10 days) |
| Evaluation of the impact of tDCS on interictal epileptic spikes | Changes in strength and density of functional links during IES before and after each tDCS session | Visit 4 (V4) - 4 weeks after the end of first cycle (each cycle is 10 days) |
| Evaluation of the impact of tDCS on interictal epileptic spikes | Changes in strength and density of functional links during IES before and after each DCS session | V7 - 4 weeks after the end of the second cycle (each cycle is 10 days) |
| Département Neurologie Fonctionnelle et Epilepsie, Hôpital neurologique - Hospices Civils de Lyon | Recruiting | Bron | 69677 | France |
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| Service de Neurophysiologie clinique - Hôpital Roger Salengro, CHU Lille | Not yet recruiting | Lille | 59037 | France |
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| Service Epileptologie et Rythmologie Cérébrale, Hôpital La Timone | Recruiting | Marseille | 13005 | France |
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| Service de Neurophysiologie clinique - GHU Psychiatrie et Neurosciences Sainte-Anne | Not yet recruiting | Paris | 75014 | France |
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| Service de Neurologie - CHU de Rennes - Hôpital Pontchaillou | Not yet recruiting | Rennes | 35033 | France |
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| Explorations neurophysiologiques - Pôle neurosciences, CHU de Toulouse, Hôpital Pierre Paul Riquet | Not yet recruiting | Toulouse | 31059 | France |
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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 |
|---|---|
| D065908 | Transcranial Direct Current Stimulation |
| D004569 | Electroencephalography |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D003295 | Convulsive Therapy |
| D013000 | Psychiatric Somatic Therapies |
| D004191 | Behavioral Disciplines and Activities |
| D004597 | Electroshock |
| D011580 | Psychological Techniques |
| D003943 | Diagnostic Techniques, Neurological |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D004568 | Electrodiagnosis |
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