Slow Oscillatory Transcranial Direct Current Stimulation for Treating Refractory Focal Epilepsy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Change in seizure frequency
研究概览
简要总结
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.
详细描述
tudy Design This was a prospective, open-label, single-arm pilot study conducted at the First Hospital of Hebei Medical University, China. Ten patients with refractory focal epilepsy (ILAE 2017 criteria) were enrolled. All patients completed the full treatment and follow-up protocol.
Participants Inclusion criteria: age 6-60 years, focal epilepsy, failed ≥2 anti-seizure medications, stable medication for ≥4 weeks, ≥2 seizures during 4-week baseline. Exclusion criteria: psychogenic nonepileptic seizures, progressive neurological disease, implanted electronic devices, pregnancy/lactation.
Intervention Slow-oscillatory tDCS (so-tDCS) was delivered using a constant-current stimulator (Hypnos Tech, China). The cathode was placed over the neuroimaging-defined epileptogenic zone (using MRI, FDG-PET, MEG, and scalp EEG). The reference anode was placed at FP1 or FP2 (contralateral). Stimulation parameters: 1 Hz sinusoidal oscillatory current, 2 mA peak-to-peak, delivered for 20 minutes per session, twice daily, with a 20-minute interval between sessions, for 14 consecutive days (total 40 minutes/day). Each session included a 20-second linear ramp-up and ramp-down. Sponge electrodes (13.68 cm²) soaked in 0.9% saline were used.
Outcome Measures Primary outcome: Percentage change in seizure frequency during treatment (14 days) and follow-up (8 weeks) compared with baseline.
Secondary outcomes: Change in interictal epileptiform discharges (IEDs) per hour on long-term EEG; change in alpha power (8-13 Hz) at Pz, CZ, P3, and C3 electrodes; safety and tolerability (adverse events); exploratory analysis of etiology (e.g., encephalomalacia vs. FCD) and treatment response.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 7 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Change in seizure frequency
时间窗: Baseline (4 weeks), during treatment (weeks 1-2), and follow-up (weeks 3-10)
Percentage change in weekly seizure frequency from baseline to the end of the 2-week treatment period, and to the end of the 8-week follow-up period.
次要结局
未报告次要终点
研究者
Shu-Juan Tian
Director, Department of Neurology
The First Hospital of Hebei Medical University