NCT07458217尚未招募不适用
Combined CM and STN Stimulation for Motor Epilepsy
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 10
- 主要终点
- Mean change in seizure frequency
研究概览
简要总结
This self-crossover, randomized controlled, pilot study aims to collect clinical data of bilateral stimulation of subthalamic nucleus (STN) combined with centromedian (CM) thalamus deep brain stimulation (DBS) for drug resistant epilepsy with motor symptom in adults.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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
- •1) 18-65 Years.
- •2) Drug Resistant Epilepsy.
- •3) Motor Epilepsy - defined as:
- •Epilepsy diagnosis meeting ILAE criteria
- •Motor Epilepsy defined as including one or more of:
- •i. Tonic, Clonic, or Tonic-Clonic activity; ii. Myoclonic Jerks; iii.Epileptic Spasms; iv.Focal Motor Seizures (identified primary lesion will be in motor functional area, such as primary motor cortex (BA4), pre-motor cortex (BA6), Central Posterior Gyrus (BA1-3), or other motor region); v.Motor activity not secondary to non-motor seizure. c.Clinical or Electrographic corroboration of at least one of: i.Video-EEG confirmation of motor seizure semiology; ii.Interictal or ictal EEG findings consistent with epileptic motor network involvement; iii.Consistent clinical description by trained cliniciants.
- •4) >3 Focal or Generalized seizures / month with an inter-seizure interval no great than 30 days.
- •5) Subject or caregiver is able to provide epileptic seizure record within 90 days prior to the surgery.
- •6) Voluntarily participate in the trial, sign the informed consent form, and be willing to comply with study requirements, including follow-ups.
排除标准
- •1) Non Motor Epilepsy.
- •2) Previous diagnosis of psychogenic/non-epileptic seizures.
- •3) Brain lesion resection or ablation surgery performed less than 6 months.
- •4) Implanted Vagus nerve stimulation (VNS) or responsive neurostimulation (RNS) devices recommended neither stimulation off the device at least 6 months nor remove the device.
- •5) Pregnant, breastfeeding, or having the intention to become pregnant during the study period (for females of childbearing potential).
研究组 & 干预措施
CM group
Active Comparator
干预措施: Deep brain stimulation (Device)
CM + STN group
Experimental
干预措施: Deep brain stimulation (Device)
结局指标
主要结局
Mean change in seizure frequency
时间窗: Baseline to after 3 month CM and CM+STN stimulation.
Adverse events related to DBS implantation
时间窗: After Device Inplanted to 12 month followup visit.
次要结局
未报告次要终点
研究者
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