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临床试验/NCT05324579
NCT05324579已完成不适用

An Integrated Single-neuronal, Population-, Local Network- and Stimulation-based Prefrontal Investigation of Human Social Cognition

Massachusetts General Hospital4 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2022年5月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
4
主要终点
Number of neurons displaying changes in activity related to task events

研究概览

简要总结

This proposal aims to study the role that the dorsal prefrontal cortex plays in human social cognition.

详细描述

Despite ongoing progress in the understanding of social behavior, little is known about the single-neuronal mechanisms that underlie human social cognition. The investigators will obtain single-neuronal recordings from the prefrontal cortex in participants undergoing clinically planned deep brain stimulation (DBS) electrode placement.

The study population will consist of subjects undergoing planned DBS placement. Prospective participants will be selected for surgery irrespective of their participation in the study. After consenting to the study, the participants will be allowed to withdraw from participation at any time. No control subjects will be used. Instead, each subject will act as their own control based on task performance.

For the study, neuronal recordings will be integrated within planned neurosurgical care and will be obtained from the prefrontal cortex as participants perform a brief behavioral task. During recordings and prior DBS placement, the participants are normally asked to make movements or answer questions based on verbal cues to aid in targeting the correct areas. The participants will be additionally asked to perform a brief linguistic-based task in which scenarios containing social agents are presented to the participants and in which they have to verbally describe/answer questions about them. Following cortical recordings and stimulation, the standard clinical procedure and DBS electrode placement proceeds as planned. The neuronal and behavioral data will then be analyzed off-line.

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

入选标准

  • 18 years old or older
  • patients able to give informed consent

排除标准

  • Children under 18
  • Significant co-morbidities
  • Claustrophobia or general anxiety that may impact intraoperative testing
  • Use of CNS-active medications including stimulants and antipsychotics which may alter
  • Operative events that will require expedition of the surgery.
  • Poor tolerance of testing by the patient
  • Increased abnormal cortical excitability
  • Necessity to administer drugs that will interfere with mapping

结局指标

主要结局

Number of neurons displaying changes in activity related to task events

时间窗: 15 minutes

Neuronal signals will be recorded during performance of a language-based social task over a 15 minute period. A multinomial logistic regression analyses will be used to evaluate for changes in neuronal activity that are associated with social versus non-social task events. Neuronal activity will be measured as the number of spikes recorded during each event, with each event lasting for approximately one second. Significance threshold will be set to p \< 0.01. The primary outcome measure will be the proportion of neurons that reach significance threshold and therefore display task-related modulation.

次要结局

  • Percentage of task events that can be correctly predicted from neuronal activity(15 minutes)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ziv Williams, MD

Associate Professor

Massachusetts General Hospital

研究点 (4)

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