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临床试验/NCT05132543
NCT05132543尚未招募不适用

Studying Human Cognition and Neurological Disorders Using µECoG Electrodes

Duke University0 个研究点目标入组 38 人开始时间: 2026年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
38
主要终点
Percentage of phoneme decoding accuracy as measured by linear decoding model

研究概览

简要总结

The overall purpose of this study is to better understand human cognition and human epilepsy by working with patients undergoing clinical treatment for pharmacologically resistant epilepsy. The investigators will investigate human cognition by conducting controlled experiments that focus on sensory, motor, and cognitive phenomena such as sensory processing, memory, and language. The investigators will also examine the neural underpinnings of epilepsy during both sleep and wakefulness to better understand both the foundations of epilepsy and how epilepsy affects cognition. The investigators hope to use these data to have a better understanding of cognition, epilepsy, and how the two interact. This will potentially lead to better markers for seizure onsets as well as epilepsy more generally. For this research, the investigators will use μECoG arrays manufactured by commercial partners. These arrays have passed all major ISO 10993 bio-compatibility tests. Based on this characterization and use in the intraoperative setting (limited duration and supervised usage), these devices pose a minimal risk to participants. Data will be analyzed and protected using the Duke SSRI protected research data network.

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
12 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Potential subjects will come from adult and pediatric patients (between the ages of 12 and 18) undergoing surgery for the treatment of pharmacologically resistant epilepsy, brain tumor resection, brain mass resection, or deep brain stimulation (DBS) for the first time
  • Proficient English speakers
  • No Major cognitive impairment

排除标准

  • Previous DBS procedure
  • Subject unable to consent to study

研究组 & 干预措施

Wireless µECoG Prosthesis for Speech

Experimental

干预措施: High density micro-electrocorticography for neural speech prothesis (Device)

结局指标

主要结局

Percentage of phoneme decoding accuracy as measured by linear decoding model

时间窗: Intraoperative data collection period, 20 minutes

Number of kriging resolution as measured by signal power.

时间窗: Intraoperative data collection period, 20 minutes

Evoked signal-to-noise analysis human brain.

时间窗: Intraoperative data collection period, 20 minutes

This study will compare the neural response sensitivity of intraoperative µECoG recording to those of in-unit recordings with macro-ECoG and SEEG. The strength and reliability of the high gamma (HG) response are critical for speech decoding algorithms. For all recordings, the HG power modulation ratio over baseline during speech perception and production will be measured and compared with non-parametric statistical tests.

Number of HG power modulation as measured by signal power.

时间窗: Intraoperative data collection period, 20 minutes

次要结局

  • Number of serious adverse events as measured by medical record review(Implantation to Three-months follow-up)

研究者

发起方
Duke University
申办方类型
Other
责任方
Sponsor

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