跳至主要内容
临床试验/NCT07084792
NCT07084792撤回不适用

Dynamic Motor Cortical Responses to Subdural Electrical Stimulation.

Medical University of South Carolina0 个研究点目标入组 50 人开始时间: 2025年8月16日最近更新:

试验速览

阶段
不适用
状态
撤回
入组人数
50
主要终点
Number of arm movements in 60 seconds

研究概览

简要总结

The purpose of this study is to better understand how subdural electrical stimulation of the brain affects motor cortical oscillations

详细描述

Direct cortical stimulation (DCS) has shown the potential to improve symptoms in patients with Parkinson's disease, however its effects have not been consistent in randomized studies to date, limiting widespread adoption of this technology. A critical gap in our knowledge is a detailed understanding of how DCS affects motor areas in the brain. Investigators propose using subdural DCS (sDCS) while simultaneously recording directly from motor cortex using subdural electrocorticography (sECoG) in patients undergoing deep brain stimulation surgery. Investigators expect this novel approach to broaden our understanding of sDCS application and possibly lead to therapeutic advances in this population.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Device Feasibility
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients diagnosed with PD and consented and scheduled for DBS surgery with the PI
  • Age 18-80

排除标准

  • Patients unable to actively participate in the consent process physically and/or cognitively
  • Previous adverse reaction to Keppra (levetiracetam)
  • Prior intracranial surgery with the exception of deep brain stimulation surgery
  • Prior brain radiotherapy
  • Prior history of intracranial tumor, intracranial infection or cerebrovascular malformation
  • Prior history of seizures

结局指标

主要结局

Number of arm movements in 60 seconds

时间窗: 60 seconds

Number of arm movements in 60 seconds

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

相似试验