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Actively Recruiting

Phase Not Applicable
Age: 9Years +
All Genders
ID06334952

Personalized Transcranial Direct Current Stimulation tDCS for Drug-Resistant Focal Epilepsy in Patients Aged 9 and Older A Randomized Cross-over Study

Led by Assistance Publique Hopitaux De Marseille · Updated on 2025-12-19

60

Participants Needed

7

Research Sites

56 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the use of personalized transcranial direct current stimulation tDCS to reduce seizure frequency in patients with drug-resistant focal epilepsy. This trial aims to compare the effects of active tDCS treatment to a sham placebo stimulation, focusing on changes in seizure frequency, quality of life, side effects, and epilepsy severity. The study uses a randomized, triple-blind, cross-over design to assess the impact of these treatments in patients who continue to experience seizures despite medication or surgery. Participants will receive two treatment cycles in random order one with active tDCS and one with sham stimulation. Each cycle consists of 10 non-consecutive days, with two 20-minute stimulation periods per day separated by a 20-minute break, totaling 40 minutes of cathodal stimulation daily. The study includes detailed brain imaging for treatment personalization and allows for a washout period between treatments in this cross-over setup. During the study, participants will be monitored at multiple visits up to 8 weeks after each treatment cycle. Researchers will assess seizure frequency and severity, quality of life, psychiatric symptoms, and any side effects. The study includes frequent evaluations to measure changes compared to baseline, with a focus on safety and treatment response. Total participation spans from baseline through follow-up visits after both treatment cycles, ensuring comprehensive monitoring of outcomes.

CONDITIONS

Brief Title

Efficacy of Personnalized Transcranial Direct Current Electrical Stimulation (tDCS) in Drug-resistant Epileptic

Research Team

F

Fabrice Bartolomei, MD, PhD

S

Sophie Tardoski

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