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临床试验/NCT04286776
NCT04286776进行中(未招募)不适用

Memory Retrieval and Encoding Investigated by Neural Stimulation

University of Pennsylvania22 个研究点 分布在 1 个国家目标入组 800 人开始时间: 2014年10月12日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
800
试验地点
22
主要终点
To use direct electrical stimulation to disentangle causal versus correlative biomarkers of verbal and spatial episodic memory

研究概览

简要总结

The purpose of this research is to understand biomarkers of human memory through correlational analyses and to use focal electrical stimulation as a causal manipulation to understand how biomarkers of memory relate to other brain states and behavioral measures.

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

  • Expected to undergo intracranial implantation and postoperative electroencephalographic monitoring as part of a standard clinical procedure for the treatment of pharmacologically resistant epilepsy
  • Age 18 or older

排除标准

  • Any physical or cognitive disability or illness that would limit their ability to perform cognitive tasks
  • Any medical condition that would, in the investigator's opinion, limit the subject's participation in the study.
  • Unable or unwilling to provide informed consent
  • MRI contraindications
  • Standard clinical care includes a pregnancy test for female patients prior to the surgical implantation of the electrodes. Pregnant women are not surgically implanted.

结局指标

主要结局

To use direct electrical stimulation to disentangle causal versus correlative biomarkers of verbal and spatial episodic memory

时间窗: Up to 4 weeks (typical duration of hospital stay)

1\. We will use linear mixed effects models and L2-penalized logistic regression classifiers to compare periods of successful and unsuccessful performance in our tasks

To develop and test models of human brain dynamics in the presence of electrical stimulation

时间窗: Up to 4 weeks (typical duration of hospital stay)

2\. We will compare spectral indices of brain activity before and after stimulation as a function of stimulation parameters.

To assess how reactivation of prior memories shapes subsequent recall and memory organization, including memory for the content, context and value of experiences.

时间窗: Up to 4 weeks (typical duration of hospital stay)

3\. We will mathematical models of neural similarity described in detail in Halpern (2024) and Manning (2011, 2012) to test the reactivation mechanisms described in Lohnas et al. (2014) and Healey and Kahana (2015).

To determine whether state-dependent stimulation can separately be used to modulate encoding and retrieval processes

时间窗: Up to 4 weeks (typical duration of hospital stay)

4\. We will evaluate the closed-loop stimulation protocol described in Kahana et al. (2023) in both encoding and retrieval.

To determine whether stimulation is more effective at modulating memory when targeted to regions with specific connectivity profiles to the medial temporal lobe

时间窗: Up to 4 weeks (typical duration of hospital stay)

5\. We will compare recall rates during a free recall experiment with brain stimulation at sites with high network-mediated activation, as described in Solomon et al. (2018), versus low network-mediated activation.

To determine how simultaneous stimulation at multiple target sites can be optimized to modulate memory

时间窗: Up to 4 weeks (typical duration of hospital stay)

6\. We will compare recall rates during a free recall experiment with no brain stimulation, stimulation at one site, and stimulation at multiple sites.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (22)

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