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莉莉的优雅时态干扰 (SLEEP-TIES)

2026年10月28日 更新者：University of Wisconsin, Madison

利用时间干扰非侵入性增强癫痫患者的睡眠稳态

This study is to evaluate the effectiveness of targeted Transcranial Electrical Stimulation with Temporal Interference (TES-TI) interventions to boost Non-Rapid Eye Movement (NREM) sleep, decrease seizures and promote emotional health in patients with epilepsy. Up to 24 participants (8 control participants for technical optimization prior to recruitment and 16 patients with epilepsy) will be enrolled and can expect to be on study for up to 24 months.

研究概览

地位

尚未招聘

条件

干预/治疗

详细说明

This is a Phase I randomized, single-blind, cross-over feasibility study comprised of 16 participants. Each participant will undergo structural and functional MRI then complete four nights of TES-TI stimulation and four nights of sham stimulation in counterbalanced order, separated by ≥1 day between visits.

Conditions on each visit are randomized and counterbalanced. During each visit, participants will complete both the REST-Q and SSS questionnaires. Full HD-EEG will be applied as well as 4-16 stimulation electrodes. Participants will then undergo an emotion regulation task (face task) wherein they are presented with positive, negative, or neutral emotional stimuli.

This is followed by a resting HD-EEG recording, then overnight stimulation. Either sham or non-sham (8 patients in each group) stimuli will be applied at times during the sleep period. Upon waking, the same questionnaires and emotion regulation tasks will be completed.

Objectives:

  • Assess the efficacy of TES-TI to boost sleep NREM slow-wave activity and spindles in patients with epilepsy overnight
  • Assess the efficacy of TES-TI to improve sleep quality and mood (REST-Q) and sleepiness (sleepiness scale) after treatment (4 nights) vs. before
  • Assess the efficacy of TES-TI to improve emotion responses (face task) and vigilance (psychomotor vigilance task; PVT) after treatment (4 nights) vs. before
  • Assess the efficacy of TES-TI to improve restorative quality of sleep (REST-Q questionnaire) after treatment (4 nights) vs. before
  • Assess the efficacy of TES-TI to reduce seizure frequency (self-reported) after treatment (4 nights) vs. before

研究类型

介入性

注册 (估计的)

24

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

学习地点

  • 美国
    • Wisconsin
      • Madison、Wisconsin、美国、53792
        • UW School of Medicine and Public Health

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 75年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • English-speaking (able to provide consent and complete questionnaires)
  • Citizen or holding permanent resident status
  • History of refractory epilepsy with intractable seizures and/or cognitive decline

Exclusion Criteria:

  • Any current or past history of neurological disorders or acquired neurological disease other than epilepsy (e.g. stroke, traumatic brain injury), including intracranial lesions
  • Current history of poorly controlled headaches including intractable or poorly controlled migraines
  • Any systemic illness or unstable medical condition that may cause a medical emergency in case of a provoked seizure (cardiac malformation, cardiac dysrhythmia, asthma, etc.)
  • Possible pregnancy or plan to become pregnant in the next 6 months
  • Any metal in the head
  • Any metal in the body
  • Any medical devices or implants (i.e. cardiac pacemaker, medication infusion pump, cochlear implant, vagal nerve stimulator) unless otherwise approved by the responsible MD
  • Dental implants
  • Permanent retainers
  • Claustrophobia (a fear of small or closed places)
  • Back problems that would prevent lying flat for several hours
  • Regular night-shift work (second or third shift)

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：交叉作业
  • 屏蔽：单身的

武器和干预

参与者组/臂
干预/治疗
实验性的：Sham Stimulation then Real Stimulation

Each participant will undergo structural and functional MRI then eight nights of intervention with possible sham or non-sham stimulation conditions.
设备：TES-TI

Real stimulation will take place on visits 2 - 5 or visits 6 - 10.

其他名称：
  • 经颅电刺激与时间干扰
其他：Sham Stimulation

Sham stimulation will take place on visits 2 - 5 or visits 6 - 10.

其他：Structural and Functional MRI

After baseline night visit 1 and before intervention visits 2 - 10. MRI is used to help determine electrode placement.

其他名称：
  • 脑电图-功能磁共振成像
  • 解剖学磁共振成像
实验性的：Real Stimulation then Sham Stimulation

Each participant will undergo structural and functional MRI then eight nights of intervention with possible sham or non-sham stimulation conditions.
设备：TES-TI

Real stimulation will take place on visits 2 - 5 or visits 6 - 10.

其他名称：
  • 经颅电刺激与时间干扰
其他：Sham Stimulation

Sham stimulation will take place on visits 2 - 5 or visits 6 - 10.

其他：Structural and Functional MRI

After baseline night visit 1 and before intervention visits 2 - 10. MRI is used to help determine electrode placement.

其他名称：
  • 脑电图-功能磁共振成像
  • 解剖学磁共振成像

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
NREM Sleep Slow-Wave Activity Measured by High-Density EEG (delta power)
大体时间：measured during 8 overnight visits, data collected up to 24 months on study

To assess the effect of TES-TI on NREM sleep slow-wave activity during treatment (4 nights) vs. sham (4 nights), slow-wave activity will be measured by high-density EEG.
measured during 8 overnight visits, data collected up to 24 months on study
Number of Seizures per week
大体时间：data collected at 4 time points up to 24 months on study, 1 month and 3 month follow up after completion of 4 nights treatment and 1 month and 3 month follow up after completion 4 nights sham condition

To assess the effect of TES-TI on incidence of seizures after treatment (4 nights) vs. sham (4 nights), participants will maintain a seizure diary. The self-reported number of seizures seizures per week for the first week and the first four-weeks post-intervention.
data collected at 4 time points up to 24 months on study, 1 month and 3 month follow up after completion of 4 nights treatment and 1 month and 3 month follow up after completion 4 nights sham condition
Psychomotor Vigilance Task (PVT)
大体时间：measured during 8 overnight visits, data collected up to 24 months on study

The vigilance task will be used to assess the effect of TES-TI on performance after treatment (4 nights) vs. sham (4 nights). This is a computerized reaction time task where a participant is presented with a fixation point on a computer screen. At random, the fixation point will change appearance at which point the participant is to click a provided button as quickly as possible. The time it took to respond is recorded automatically by the computer program and will be reported as the result.
measured during 8 overnight visits, data collected up to 24 months on study
Restorative Sleep Questionnaire (REST-Q)
大体时间：measured during 8 overnight visits, data collected up to 24 months on study

The REST-Q measure will be used to assess the effect of TES-TI on sleep quality and mood after treatment (4 nights) vs. sham (4 nights). It is a 9-item questionnaire assessing aspects of restorative sleep. Each item is scored on a 5-point Likert scale (1-light; 5-deep). Final scores are transformed to a scale of 0-100 here higher scores indicate more restorative sleep.
measured during 8 overnight visits, data collected up to 24 months on study
Stanford Sleepiness Scale (SSS)
大体时间：measured during 8 overnight visits, data collected up to 24 months on study

The Stanford Sleepiness Scale will be used to assess sleepiness after treatment (4 nights) vs. sham (4 nights). SSS is a measure of subjective alertness on a 7-point scale (total range of scores from 1-7). A lower score on the scale indicates higher alertness.
measured during 8 overnight visits, data collected up to 24 months on study
Emotional Processing Task (Face Task): Percent Correct
大体时间：measured during 8 overnight visits, data collected up to 24 months on study

The Face Task will be used to assess the effect of TES-TI on emotion response after treatment (4 nights) vs. sham (4 nights). This task involves viewing a series of emotionally charged images (60 positive, 60 negative, 60 neutral).
measured during 8 overnight visits, data collected up to 24 months on study
Emotional Processing Task (Face Task): Percent Change in Reaction Time
大体时间：measured during 8 overnight visits, data collected up to 24 months on study

The Face Task will be used to assess the effect of TES-TI on emotion response after treatment (4 nights) vs. sham (4 nights). This task involves viewing a series of emotionally charged images (60 positive, 60 negative, 60 neutral).
measured during 8 overnight visits, data collected up to 24 months on study

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

University of Wisconsin, Madison

合作者

Lily's Fund for Epilepsy Research

调查人员

  • 首席研究员：Melanie Boly, MD, PhD、UW School of Medicine and Public Health

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年11月1日

初级完成 (估计的)

2028年9月1日

研究完成 (估计的)

2028年9月1日

研究注册日期

首次提交

2026年4月2日

首先提交符合 QC 标准的

2026年4月2日

首次发布 (实际的)

2026年4月9日

研究记录更新

最后更新发布 (实际的)

2026年10月30日

上次提交的符合 QC 标准的更新

2026年10月28日

最后验证

2026年8月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • 2025-1852
  • SMPH | NRL Neurology (其他标识符：UW Madison)
  • Protocol Version 2/17/26 (其他标识符：UW Madison)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 共享支持信息类型

  • 研究方案
  • 树液
  • 国际碳纤维联合会

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

是的

在美国制造并从美国出口的产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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