The Efficacy and Safety of Subiculum Electrical Stimulation for Temporal Lobe Epilepsy With Bilateral Hippocampal Sclerosis: A Prospective, Single-Arm Pilot Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Seizure frequency (SF28)
研究概览
简要总结
The primary objective of this research is to study the efficacy and safety of deep brain stimulation (DBS) of Subiculum as adjunctive therapy for reducing the frequency of seizures in drug-resistant temporal lobe epilepsy with bilateral hippocampal sclerosis
详细描述
This project aims to include 6 participants, and evaluate the effectiveness and safety of bilateral hippocampal subcortical stimulation in patients with temporal lobe epilepsy and bilateral hippocampal sclerosis through A prospective, interventional, unblinded, single-arm clinical trial. It is expected to provide new therapeutic options for patients with temporal lobe epilepsy and bilateral hippocampal sclerosis with alternative treatment options.
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
- 14 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants are between the ages of 14 -65 years of age
- •Refractory to anti-seizure medications (ASMs).
- •Persistence of disabling seizures at least 3 times per 3 months or greater, and once or more in recent 1 month.
- •After comprehensive preoperative evaluation, patients who are considered unsuitable for or refuse resection surgery, or those for whom the effects of epileptic focus resection and thermocoagulation surgery are not satisfactory.
- •Participants must have had a non-invasive video-EEG monitoring revealing seizure semiology and ictal EEG consistent with bilateral Temporal Lobe Epilepsy
- •Biliteral hippocampal atrophy on MRI T1 imaging with increased ipsilateral mesial signal on T2 imaging
- •Informed consent signed.
排除标准
- •Diagnosed with generalized or hereditary epilepsy with ion channel gene mutations;
- •Psychogenic non-epileptic seizures within 12 months;
- •Presence of implanted electrical stimulation medical device anywhere in the body (e.g., pacemaker, spinal cord stimulator, responsive neurostimulation) or any metallic implants in the head (e.g., aneurysm clips, cochlear implants). Note: Vagal nerve stimulators are allowed if the parameter remains stable for at least 3 months prior to the screening visit;
- •Risk factors that would put the participant at risk for intraoperative or postoperative bleeding. (e.g., coagulation abnormalities, etc.) or the need for chronic anticoagulation or antiplatelet aggregation medications;
- •IQ < 55 or severe cognitive dysfunction, unable to complete the study;
- •Diagnosed with a progressive neurological disorder (including progressive Rasmussen's encephalitis, etc.);
- •Diagnosed with a severe neuropsychiatric disorder such as dementia, major depression (admission to a psychiatric specialty/hospital within 5 years or any suicidal or self-injurious tendencies), schizophrenia, or neurodegenerative disorders;
- •Diagnosed with other serious physical disorders, internal diseases or severe abnormalities in liver or kidney function;
- •Pregnant, or planning to pregnant within 2 years;
- •Participation in another clinical study within 3 months;
- •Not suitable for enrollment as assessed by the multidisciplinary team of the center.
结局指标
主要结局
Seizure frequency (SF28)
时间窗: Up to 1 year after subculum-DBS
Seizure frequency (SF28) is defined as seizure count per month (28-day) period. The SF28 is calculated as follows, where D=total number of days for which seizure information is collected for the specific 28-day interval: SF28=(Total number of seizures in D days/D)\*28. In addition, the baseline seizure frequency is defined as mean of 3-month SF28 in the baseline period. The seizure frequency in open-label phase is defined as SF28 per month during the open-label period. Percent change in seizure frequency=100\*(open-label SF28-baseline SF28)/baseline SF28.
次要结局
- Cognitive function evaluation (MMSE)(Up to 1 year after subculum-DBS)
- Incidence of Sudden Unexpected Death in Epilepsy (SUDEP)(Up to 1 year after subculum-DBS)
- Seizure Responder Rate(Up to 1 year after subculum-DBS)
- Adverse Events(Up to 1 year after subculum-DBS)
- Life quality evaluation(Up to 1 year after subculum-DBS)
- Cognitive function evaluation (MoCA)(Up to 1 year after subculum-DBS)
研究者
Liankun_Ren
Professor
Xuanwu Hospital, Beijing