Study on the Effect of Temporal Interference Stimulation in the Therapy of Drug Resistant Temporal Lobe Epilepsy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 主要终点
- Seizure Frequency Rate Change of One Month
研究概览
简要总结
Temporal interference (TI) stimulation is a new neuromodulation method. Compared with traditional neuromodulation therapy, TI has deep targeting and focusing, and it has been confirmed to modulate sleep, cognition, and movement disorders. Recent study shown that TI stimulation targeting the hippocampus could significantly reduce epileptiform discharges, but its efficacy on seizures was still unclear. Therefore, the aim of this study is to observe the therapeutic effect of TI stimulation targeting the hippocampus in patients with refractory temporal lobe epilepsy (TLE) for 5 days, and to provide support for clinical trials of non-invasive treatment of refractory TLE.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 to 65 years old;
- •According to the 2010 International League Against Epilepsy (ILAE) diagnostic criteria for drug-resistant epilepsy;
- •Temporal lobe epilepsy assessed by semiology, video electroencephalogram, and imaging;
- •The duration of epilepsy was ≥2 years, and the average seizure frequency was ≥2 times per month in the 3 months before enrollment;
- •Taking two or more antiepileptic drugs and continuing the same drug regimen for the duration of the trial;
- •Could cooperate with the completion of treatment and related examinations;
- •Patients and their family members fully understood and voluntarily signed the informed consent.
排除标准
- •The anti-seizure medication therapy was adjusted during the treatment and follow-up period;
- •Patient in status epilepticus;
- •Patient with other systemic diseases leading to nervous system involvement and seizures;
- •Patients with severe infection, cerebrovascular disease, malignant tumor and other diseases, accompanied by severe dysfunction of heart, liver, kidney and other organs, or accompanied by severe mental or cognitive impairment, or intractable hyperglycemia, or long-term use of corticosteroids;
- •Patient with pregnant or lactating;
- •Patients with contraindications to TI stimulation, fMRI examination or EEG examination, metal implants (pacemakers, metal dentures, metal IUD rings, etc.), or claustrophobia;
- •Participating in other clinical trials;
- •Patients or their family members withdrew informed consent.
研究组 & 干预措施
Temporal interference
干预措施: TI Stimulation (Device)
结局指标
主要结局
Seizure Frequency Rate Change of One Month
时间窗: One month after treatment
次要结局
- Rate of Seizure Frequency Rate Change of Two Month(Two month after treatment)
- Electroencephalogram Change(Baseline, 24 hours after treatment, one month after treatment, two months after treatment)