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临床试验/NCT07217080
NCT07217080Enrolling By Invitation不适用

Thalamocortical Interactions and the Effect of Thalamic Stimulation on Sleep Oscillations

Massachusetts General Hospital4 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2025年1月6日最近更新:

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
50
试验地点
4
主要终点
Change from pre-stimulation baseline of sleep spindle rate

研究概览

简要总结

The thalamus plays a key role in supporting sleep and is also a target of therapeutic stimulation. This project investigates when, where, and how electrical stimulation delivered to the thalamus in humans elicits or disrupts sleep oscillations. This research is a first step to better understand how current neuromodulation therapies affect sleep and may help advance toward new therapies to improve sleep for a wide range of neurological and neuropsychological disorders.

详细描述

The thalamus plays a key role in supporting sleep. The thalamus is also increasingly used as a stimulation therapeutic target, but the effect of thalamic stimulation on sleep has not been investigated.

We hypothesize that electrical stimulation delivered to the thalamus in humans could both elicit and disrupt sleep oscillations, such as spindles, depending on the timing and location of stimulation. We propose a study to obtain direct evidence in humans of how thalamic stimulation affects sleep.

We will test the hypothesis that stimulation during a thalamic sleep spindle disrupts it, while stimulation outside evokes a response resembling a k-complex followed by a spindle. Participants will be patients with refractory epilepsy who have semi-chronically implanted depth electrodes in the thalamus and other brain regions (~100) as part of the pre-surgical clinical work-up. We will detect spindles and stimulate during or outside oscillations using a real-time closed-loop system that we developed. Simultaneously recording across the brain will comprehensively map the effect and extent of thalamic stimulation on sleep oscillations.

This will be the first step to unravel the effect of thalamic stimulation on sleep oscillations and maintenance. This will increase our understanding of the thalamus as a relay of sleep oscillations and could have profound implications to ensure good sleep quality for the increasing number of people implanted with therapeutic stimulation.

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
5 Years 至 85 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients getting intracranial recordings for clinical purposes who, as part of that plan, will receive thalamic electrodes.

排除标准

  • previous extensive resection or large atrophy

结局指标

主要结局

Change from pre-stimulation baseline of sleep spindle rate

时间窗: 10 to 3000 milliseconds following stimulation

An increase in spindle rate is achieved if at least 50% of trials evoke a spindle as measured on intracranial EEG following stimulation. A spindle is evoked when the power in the 10-16Hz band is larger than pre-stimulation baseline power by at least 2 standard deviations.

次要结局

  • Number of channels with responses to stimulation(10 to 3000 milliseconds following stimulation)

研究者

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

Rina Zelmann

Principal Investigator

Massachusetts General Hospital

研究点 (4)

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