Temporal Interference Brain Stimulation for Adults With Drug-Resistant Epilepsy Undergoing Stereo-EEG Monitoring
2026年8月10日 更新者：Duke University
Temporally Interfering Electric Field Stimulation in the Treatment of Epilepsy - Effect of Temporal Interference on Biomarkers of Epilepsy
This study evaluates whether a non-invasive brain stimulation technique called Temporal Interference (TI) can reduce epilepsy-related abnormal brain activity and influence sleep-related brain rhythms in adults with focal drug-resistant epilepsy undergoing stereo-EEG monitoring for clinical care.
Up to 30 participants will complete stimulation sessions during wakefulness and, when possible, natural non-REM sleep.
Brain activity will be recorded using scalp EEG and implanted sEEG electrodes before, during, and after TI stimulation.
Some participants may also receive subthreshold direct stimulation through implanted electrodes for comparison.
The study aims to determine whether TI can reduce epilepsy biomarkers, alter sleep-related brain activity, and compare favorably with conventional direct electrical stimulation while remaining within established safety limits.
研究概览
地位
尚未招聘
研究类型
介入性
注册 (估计的)
30
阶段
- 不适用
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
- 成人
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria:
- Adult patients with focal DRE who will undergo presurgical evaluation with sEEG
- Availability of at least one sEEG electrode inserted into the thalamus for clinical purposes
- sEEG performed with the indication to identify one single epileptic focus
- Ability to provide written informed consent and comply with the study protocol
Exclusion Criteria:
- Remote resective/ablative brain surgery
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：基础科学
- 分配：随机化
- 介入模型：交叉作业
- 屏蔽：三倍
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Temporal Interference Stimulation to Epileptic Focus
Temporal Interference stimulation delivered through scalp electrodes targeting the epileptic focus during wakefulness and/or natural NREM sleep.
|
Non-invasive electrical stimulation delivered through scalp electrodes using paired sinusoidal currents with differential carrier frequencies to create a low-frequency envelope targeting deep brain structures including the epileptic focus or thalamus.
|
|
实验性的：Temporal Interference Stimulation to Thalamus
Temporal Interference stimulation delivered through scalp electrodes targeting the thalamus during wakefulness and/or natural NREM sleep.
|
Non-invasive electrical stimulation delivered through scalp electrodes using paired sinusoidal currents with differential carrier frequencies to create a low-frequency envelope targeting deep brain structures including the epileptic focus or thalamus.
|
|
有源比较器：Direct Electrical Stimulation
Subthreshold direct electrical stimulation delivered through implanted sEEG contacts.
|
Subthreshold biphasic electrical stimulation delivered through implanted stereo-EEG contacts, remaining below thresholds for after-discharges and perceptual sensations.
|
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 |
|---|---|---|
|
Interictal epileptiform discharge rate
大体时间：20-minute baseline, 20-minute stimulation, 20-minute post-stimulation
|
The interictal epileptiform discharge (IED) rate per minute is a classical biomarker of epilepsy.
It is derived from sEEG macro- and microcontacts.
|
20-minute baseline, 20-minute stimulation, 20-minute post-stimulation
|
|
Single-unit firing rate
大体时间：20-minute baseline, 20-minute stimulation, 20-minute post-stimulation
|
single unit firing rate is the number of action potentials ("spikes") that an isolated neuron emits per second.
It is derived from sEEG microcontacts.
|
20-minute baseline, 20-minute stimulation, 20-minute post-stimulation
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
High-frequency oscillations
大体时间：20-minute baseline, 20-minute stimulation, 20-minute post-stimulation
|
The high-frequency oscillation rate per minute (frequency >80 Hz) is an alternative biomarker of epilepsy.
it is derived from sEEG macro- and microcontacts.
|
20-minute baseline, 20-minute stimulation, 20-minute post-stimulation
|
|
local field potential spectral power
大体时间：20-minute baseline, 20-minute stimulation, 20-minute post-stimulation
|
The power of local field potentials in defined frequency bands (theta: 4-8 Hz, beta: 13-30 Hz, gamma: 30-100 Hz) will be measured from macro- and microcontacts.
|
20-minute baseline, 20-minute stimulation, 20-minute post-stimulation
|
|
Sleep microstructure
大体时间：20-minute baseline, 20-minute stimulation, 20-minute post-stimulation
|
Sleep microstructure is comprised of sleep spindles (sleep specific transients of 10-16 Hz exceeding 0.5 seconds) and slow oscillations (delta wave transients < 0.5 Hz) measured in scalp EEG and sEEG macrocontacts.
Rates are provided per minute
|
20-minute baseline, 20-minute stimulation, 20-minute post-stimulation
|
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。
调查人员
- 首席研究员：Birgit Frauscher、Duke University
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8月15日
初级完成 (估计的)
2031年8月14日
研究完成 (估计的)
2031年8月14日
研究注册日期
首次提交
2026年8月10日
首先提交符合 QC 标准的
2026年8月10日
首次发布 (实际的)
2026年8月14日
研究记录更新
最后更新发布 (实际的)
2026年8月14日
上次提交的符合 QC 标准的更新
2026年8月10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
其他研究编号
- PRO00119776
- 1R56NS148323-01 (美国 NIH 拨款/合同)
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 计划说明
Annotated preprocessed datasets and final research data will be shared.
IPD 共享时间框架
IPD will be shared upon their initial online publication or 1-year following the end of the project.
IPD 共享访问标准
Data Archive for the BRAIN Initiative (DABI)
IPD 共享支持信息类型
- 分析代码
- 企业社会责任
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.