Transcranial Direct Current Stimulation
DeviceResearch MRI includes 3D-T1 weighted MRI (3D-T1), diffusion MRI (dMRI), resting-state functional MRI (rsfMRI).
Other names: Research MRI, EEG
NCT Number: NCT06334952
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).
Interested in participating?
Request Info9 year and older
All sexes
Interventional
Not applicable
Service de Neurophysiologie Clinique de l'Enfant et de L'Adulte, Pôle de Neurosciences Cliniques, Bordeaux, France
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Research MRI includes 3D-T1 weighted MRI (3D-T1), diffusion MRI (dMRI), resting-state functional MRI (rsfMRI).
Other names: Research MRI, EEG
Time frame: Visit 4 (V4) - 4 weeks after the end of first cycle (each cycle is 10 days)
Seizure frequency counting after end of tDCS treatment compared to the baseline comparing Sham versus Active arms of the cross-over study.
Time frame: V5 - 8 weeks after the end of first cycle (each cycle is 10 days)
Seizure frequency counting after end of tDCS treatment compared to the baseline comparing Sham versus Active arms of the cross-over study.
Time frame: V7 - 4 weeks after the end of the second cycle (each cycle is 10 days)
Seizure frequency counting after end of tDCS treatment compared to the baseline comparing Sham versus Active arms of the cross-over study.
Time frame: V8 - 8 weeks after the end of the second cycle (each cycle is 10 days)
Seizure frequency counting after end of tDCS treatment compared to the baseline comparing Sham versus Active arms of the cross-over study.
Time frame: Visit 4 (V4) - 4 weeks after the end of first cycle (each cycle is 10 days)
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
Time frame: V5 - 8 weeks after the end of first cycle (each cycle is 10 days)
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
Time frame: V7 - 4 weeks after the end of the second cycle (each cycle is 10 days)
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
Time frame: V8 - 8 weeks after the end of the second cycle (each cycle is 10 days)
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
Time frame: Visit 4 (V4) - 4 weeks after the end of first cycle (each cycle is 10 days)
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
Time frame: V5 - 8 weeks after the end of first cycle (each cycle is 10 days)
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
Time frame: V7 - 4 weeks after the end of the second cycle (each cycle is 10 days)
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
Time frame: V8 - 8 weeks after the end of the second cycle (each cycle is 10 days)
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
Time frame: Visit 4 (V4) - 4 weeks after the end of first cycle (each cycle is 10 days)
Changes from baseline in the quality of life questionnaire (QOLIE 31 for adults and EFIQUACEE QOL for children) after the stimulation period
Time frame: V5 - 8 weeks after the end of first cycle (each cycle is 10 days)
Changes from baseline in the quality of life questionnaire (QOLIE 31 for adults and EFIQUACEE QOL for children) after the stimulation period
Time frame: V7 - 4 weeks after the end of the second cycle (each cycle is 10 days)
Changes from baseline in the quality of life questionnaire (QOLIE 31 for adults and EFIQUACEE QOL for children) after the stimulation period
Time frame: V8 - 8 weeks after the end of the second cycle (each cycle is 10 days)
Changes from baseline in the quality of life questionnaire (QOLIE 31 for adults and EFIQUACEE QOL for children) after the stimulation period
Time frame: Visit 4 (V4) - 4 weeks after the end of first cycle (each cycle is 10 days)
Changes in the scores of epilepsy severity (NHS3) (investigator evaluation)
Time frame: V5 - 8 weeks after the end of first cycle (each cycle is 10 days)
Changes in the scores of epilepsy severity (NHS3) (investigator evaluation)
Time frame: V7 - 4 weeks after the end of the second cycle (each cycle is 10 days)
Changes in the scores of epilepsy severity (NHS3) (investigator evaluation)
Time frame: V8 - 8 weeks after the end of the second cycle (each cycle is 10 days)
Changes in the scores of epilepsy severity (NHS3) (investigator evaluation)
Time frame: Visit 4 (V4) - 4 weeks after the end of first cycle (each cycle is 10 days)
Changes from baseline in depression (NDDI-E) and anxiety (GAD-7) scores
Time frame: V5 - 8 weeks after the end of first cycle (each cycle is 10 days)
Changes from baseline in depression (NDDI-E) and anxiety (GAD-7) scores
Time frame: V7 - 4 weeks after the end of the second cycle (each cycle is 10 days)
Changes from baseline in depression (NDDI-E) and anxiety (GAD-7) scores
Time frame: V8 - 8 weeks after the end of the second cycle (each cycle is 10 days)
Changes from baseline in depression (NDDI-E) and anxiety (GAD-7) scores
Time frame: Visit 4 (V4) - 4 weeks after the end of first cycle (each cycle is 10 days)
Percent of newly reported side-effect during and after the stimulation period
Time frame: V5 - 8 weeks after the end of first cycle (each cycle is 10 days)
Percent of newly reported side-effect during and after the stimulation period
Time frame: V7 - 4 weeks after the end of the second cycle (each cycle is 10 days)
Percent of newly reported side-effect during and after the stimulation period
Time frame: V8 - 8 weeks after the end of the second cycle (each cycle is 10 days)
Percent of newly reported side-effect during and after the stimulation period
Time frame: V5 - 8 weeks after the end of first cycle (each cycle is 10 days)
Changes in functional connectivity measured by fMRI and EEG signal 4 weeks after the tDCS periods in comparison with baseline period
Time frame: Visit 4 (V4) - 4 weeks after the end of first cycle (each cycle is 10 days)
Change in the number of IESs per time unit after each tDCS session in comparison with baseline period
Time frame: Visit 4 (V4) - 4 weeks after the end of first cycle (each cycle is 10 days)
Change in localization and extent of brain areas involved in IESs before and after each tDCS session in comparison with baseline period
Time frame: V7 - 4 weeks after the end of the second cycle (each cycle is 10 days)
Change in localization and extent of brain areas involved in IESs before and after each tDCS session in comparison with baseline period
Time frame: Visit 4 (V4) - 4 weeks after the end of first cycle (each cycle is 10 days)
Changes in strength and density of functional links during IES before and after each tDCS session
Time frame: V7 - 4 weeks after the end of the second cycle (each cycle is 10 days)
Changes in strength and density of functional links during IES before and after each DCS session
Contact information is provided by the study sponsor or research team.
Assistance Publique Hopitaux De Marseille
Other
Model-based Multichannel Transcranial Direct Current Electrical Stimulation (tDCS) in Drug-resistant Epilepsy: A Cross-over Study of Efficacy
Acronym: GALVANI GS-3
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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