NCT05600738招募中不适用
Network Effects of Therapeutic Deep Brain Stimulation
The University of Texas Health Science Center, Houston2 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2022年8月26日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Change in amplitude of evoked potentials metrics as assessed by the scalp EEG
研究概览
简要总结
The purpose of this study is to map the acute, short-term cortical evoked responses to thalamic electrical stimulation in persons with intractable epilepsy
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosis of Epilepsy
- •undergoing neuromodulation therapy with clinically implanted neuromodulation devices (DBS, RNS)
- •followed in the outpatient epilepsy clinic
排除标准
- •pregnant women
- •active psychosis, major depression, or suicidal ideation in the preceding year
- •Intelligence quotient (IQ) less than 70 as measured by clinical neuropsychological evaluation
- •Do not agree to share their medical records for research purposes
结局指标
主要结局
Change in amplitude of evoked potentials metrics as assessed by the scalp EEG
时间窗: Baseline, post intervention (about 2 hours after baseline )
Change in latencies of evoked potentials and phase synchronization metrics recorded as assessed by the scalp EEG
时间窗: Baseline, post intervention (about 2 hours after baseline )
次要结局
- Change in reaction time to visual stimuli measured as vigilance score assessed by the Psychomotor Vigilance test (PVT)(Baseline, post intervention (about 2 hours after baseline))
研究者
Sandipan Pati, MD
Associate Professor
The University of Texas Health Science Center, Houston
研究点 (2)
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