Transcranial Direct Current Stimulation for Focal Refractory Epilepsy in Mitochondrial Disease (TRANSFORM)
Study Overview
This study investigates the effectiveness of Transcranial DC Stimulation (tDCS) for treating focal epilepsy in patients with mitochondrial disease. Focal epilepsy is common in these patients and can be hard to treat with medications, leading to serious conditions like refractory focal status epilepticus.
Study Design
We conducted a double-blinded, sham-controlled study, which is the first of its kind for this condition. Participants aged 2 years and older with a confirmed mitochondrial disease diagnosis and drug-resistant focal epilepsy will be included. We aim to treat 30 episodes of focal status epilepticus over a maximum of 14 days.
Intervention Details
Participants in the early start group will receive tDCS from day 1, while those in the delayed start group will receive a placebo until day 3. Our main goal is to see a reduction of over 50% in seizure frequency compared to the baseline. We will also monitor brain changes through MRI and EEG.
Potential Impact
If the results show that tDCS is effective, it could become a standard treatment for focal seizures in patients with mitochondrial disease.
Clinical Trials Registration
Registered under ISRCTN: 18,241,112 on 16/11/2021.
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