Slow Oscillatory Transcranial Direct Current Stimulation for Refractory Focal Epilepsy (NCT07684352) | Clinical Trial Compass
CompletedNot Applicable
Slow Oscillatory Transcranial Direct Current Stimulation for Refractory Focal Epilepsy
China10 participantsStarted 2024-01-13
Plain-language summary
This pilot study evaluated whether a type of non-invasive brain stimulation called slow-oscillatory transcranial direct current stimulation (so-tDCS) can reduce seizure frequency in patients with drug-resistant focal epilepsy. Ten patients received 14 days of so-tDCS (2 mA, 1 Hz) for 20 minutes twice daily, guided by their individual seizure focus identified by EEG and MRI. Seizure frequency and epileptiform discharges were measured before, during, and up to 8 weeks after treatment. The study also assessed safety and tolerability. Results showed that so-tDCS significantly reduced seizure frequency, with the greatest effect occurring during the first week of treatment, and the benefit was sustained during follow-up. No serious adverse events were reported. These preliminary findings suggest that so-tDCS may be a safe and effective non-invasive option for refractory focal epilepsy, but larger sham-controlled trials are needed to confirm efficacy.
Who can participate
Age range
7 Years – 60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria were established as follows:(1)a confirmed diagnosis of focal-onset seizures, with or without focal-to-bilateral tonic-clonic evolution, according to the ILAE 2017 classification; (2)a disease duration of at least 2 years; (3)pharmacoresistance, defined as failure of adequately tried, appropriately chosen, and well-tolerated trials of at least two antiseizure medications (ASMs); (4)a stable ASM regimen for at least 4 weeks prior to baseline with agreement to maintain the same regimen throughout the study; (5)concurrent use of one to five ASMs; (6)at least two seizures during the 4-week baseline observation period.
Exclusion criteria included:(1) psychogenic nonepileptic seizures; (2) progressive neurological or systemic disorders other than epilepsy; (3) pregnancy or breastfeeding; (4) substance abuse; (5) the presence of implanted electrical medical devices.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in seizure frequency
Timeframe: Baseline (4 weeks), during treatment (weeks 1-2), and follow-up (weeks 3-10)
Trial details
NCT IDNCT07684352
SponsorThe First Hospital of Hebei Medical University