Temporal Interference Stimulation of Hypothalamus in Patients With Narcolepsy Type 1 (TINY)
2026年8月3日 更新者：Xijing Hospital
Efficacy and Safety of Temporal Interference Stimulation of Hypothalamus in Patients With Narcolepsy Type 1: A Randomised, Double-blind, Sham-Controlled, Single-Centre Trial
Narcolepsy type 1 (NT1) is a chronic brain disorder caused by selective loss or dysfunction of orexin (hypocretin) neurons in the lateral hypothalamus, for which current pharmacological treatments offer limited efficacy.
Temporal interference (TI) stimulation is a recently developed noninvasive neuromodulation technique that enables focal modulation of deep brain structures.
In this randomized, double-blind study, we developed a theta-burst patterned TI protocol and evaluated its effects in patients with NT1.
研究概览
地位
招聘中
条件
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
- 姓名：Bei He
- 电话号码：+86-29-84771377
- 邮箱：1569451844@qq.com
学习地点
-
-
Shaanxi
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Xi'an、Shaanxi、中国、710032
- 招聘中
- Xijing Hospital
-
接触：
- Wen Tian Gao
- 电话号码：+86-29-84771794
- 邮箱：customer@notice.rh-clinical.com
-
-
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
- 孩子
- 成人
接受健康志愿者
不
描述
Inclusion Criteria:
- Aged 12 to 60 years.
- Diagnosis of narcolepsy type 1 according to the International Classification of Sleep Disorders, Third Edition (ICSD-3), confirmed by polysomnography (PSG) and/or Multiple Sleep Latency Test (MSLT) performed within the past 10 years, with the test procedures meeting the minimum technical standards specified in the ICSD-3.
- Epworth Sleepiness Scale score >12 at baseline.
- Signed informed consent.
Exclusion Criteria:
- Presence of other conditions that cause excessive daytime sleepiness, including restless legs syndrome, periodic limb movement disorder, or moderate-to-severe obstructive sleep apnea syndrome, etc.
- History of epilepsy, severe neuropsychiatric disorders, or significant cardiac, hepatic, or renal dysfunction.
- Pregnancy or current breastfeeding.
- Contraindications to MRI or electrical stimulation therapy, such as intracranial metallic foreign bodies, cardiac pacemakers, implantable cardioverter-defibrillators, or cochlear implants.
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：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Active TI stimulation
Participants will receive twice-daily TI stimulation, administered 4 hours apart or more, for 2 weeks.
The current will be applied for 40 minutes per session.
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For the active TI stimulation, the current was applied for 40 minutes per session.
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假比较器：Sham TI stimulation
Participants will receive twice-daily TI stimulation, administered 4 hours apart or more, for 2 weeks.
Each session is scheduled for 40 minutes, but actual current is delivered only as a short 30-second pulse at the start and at the end, with no current applied in between.
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For the sham stimulation, a brief 30-second current was delivered at the beginning and at the end of each session, with no current applied in between.
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
Change from baseline to week 2 in mean sleep latency from the MWT
大体时间：Baseline, Week 2
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Baseline, Week 2
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The incidence of adverse events and serious adverse events
大体时间：Baseline, 2-week treatment period, 4-week follow-up period
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Baseline, 2-week treatment period, 4-week follow-up period
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change from baseline to week 2 in Epworth Sleepiness Scale total score
大体时间：Baseline, Week 2
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The Epworth Sleepiness Scale total score ranges from 0 to 24, with higher scores reflecting more severe daytime sleepiness
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Baseline, Week 2
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Change from baseline to week 2 in Narcolepsy Severity Scale score
大体时间：Baseline, Week 2
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The Narcolepsy Severity Scale score comprises 15 items assessing the frequency and severity of excessive daytime sleepiness, cataplexy, hypnagogic hallucinations, sleep paralysis, and disrupted nighttime sleep (total score 0-57, higher scores indicating greater severity)
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Baseline, Week 2
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Change from baseline to week 2 in weekly cataplexy frequency
大体时间：Baseline, Week 2
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Baseline, Week 2
|
|
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Change from baseline to weeks 1, 2, 3, and 4 following treatment in Epworth Sleepiness Scale total score
大体时间：Weeks 1, 2, 3, and 4 following treatment
|
The Epworth Sleepiness Scale total score ranges from 0 to 24, with higher scores reflecting more severe daytime sleepiness
|
Weeks 1, 2, 3, and 4 following treatment
|
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Change from baseline to weeks 1, 2, 3, and 4 following treatment in Narcolepsy Severity Scale score
大体时间：Weeks 1, 2, 3 and 4 following treatment
|
The Narcolepsy Severity Scale score comprises 15 items assessing the frequency and severity of excessive daytime sleepiness, cataplexy, hypnagogic hallucinations, sleep paralysis, and disrupted nighttime sleep (total score 0-57, higher scores indicating greater severity)
|
Weeks 1, 2, 3 and 4 following treatment
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Change from baseline to weeks 1, 2, 3, and 4 following treatment in weekly cataplexy frequency
大体时间：Weeks 1, 2, 3 and 4 following treatment
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Weeks 1, 2, 3 and 4 following treatment
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Blinding efficacy
大体时间：Week 2
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Participants' subjective guess of whether they received TI (yes, no, or uncertain).
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Week 2
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Change from baseline to week 2 in sleep latency and nighttime sleep architecture derived from PSG
大体时间：Baseline, Week 2
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Baseline, Week 2
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Change from baseline to week 2 in power spectral density derived from EEG
大体时间：Baselien, Week 2
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Baselien, Week 2
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Change from baseline to week 2 in functional connectivity derived from MRI
大体时间：Baseline, Week 2
|
Baseline, Week 2
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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。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Grossman N, Bono D, Dedic N, Kodandaramaiah SB, Rudenko A, Suk HJ, Cassara AM, Neufeld E, Kuster N, Tsai LH, Pascual-Leone A, Boyden ES. Noninvasive Deep Brain Stimulation via Temporally Interfering Electric Fields. Cell. 2017 Jun 1;169(6):1029-1041.e16. doi: 10.1016/j.cell.2017.05.024.
- Wessel MJ, Beanato E, Popa T, Windel F, Vassiliadis P, Menoud P, Beliaeva V, Violante IR, Abderrahmane H, Dzialecka P, Park CH, Maceira-Elvira P, Morishita T, Cassara AM, Steiner M, Grossman N, Neufeld E, Hummel FC. Noninvasive theta-burst stimulation of the human striatum enhances striatal activity and motor skill learning. Nat Neurosci. 2023 Nov;26(11):2005-2016. doi: 10.1038/s41593-023-01457-7. Epub 2023 Oct 19.
- Xu S, Cui H, Xiao X, Manshaii F, Hong G, Chen J. Precision at Deep Brain: Noninvasive Temporal Interference Stimulation. ACS Nano. 2025 Nov 25;19(46):39589-39614. doi: 10.1021/acsnano.5c15238. Epub 2025 Nov 13.
- Perez-Carbonell L, Lyons E, Gnoni V, Higgins S, Otaiku AI, Leschziner GD, Drakatos P, d'Ancona G, Kent BD. Adherence to wakefulness promoting medication in patients with narcolepsy. Sleep Med. 2020 Jun;70:50-54. doi: 10.1016/j.sleep.2020.02.013. Epub 2020 Feb 26.
- Hastings NE, Abdi KE, Bibi F, Aslam B, Nunez MR, Sherani MTR, Shadmani S, Alam U, Hassan VM, Hoor-E-Ainaa, Imran H, Hanna J, Sadat SH. Narcolepsy: Pathophysiology, Diagnosis, Management, and Future Directions, a Narrative Review. Brain Behav. 2025 Dec;15(12):e71116. doi: 10.1002/brb3.71116.
- Bassetti CLA, Adamantidis A, Burdakov D, Han F, Gay S, Kallweit U, Khatami R, Koning F, Kornum BR, Lammers GJ, Liblau RS, Luppi PH, Mayer G, Pollmacher T, Sakurai T, Sallusto F, Scammell TE, Tafti M, Dauvilliers Y. Narcolepsy - clinical spectrum, aetiopathophysiology, diagnosis and treatment. Nat Rev Neurol. 2019 Sep;15(9):519-539. doi: 10.1038/s41582-019-0226-9. Epub 2019 Jul 19.
- Thannickal TC, Moore RY, Nienhuis R, Ramanathan L, Gulyani S, Aldrich M, Cornford M, Siegel JM. Reduced number of hypocretin neurons in human narcolepsy. Neuron. 2000 Sep;27(3):469-74. doi: 10.1016/s0896-6273(00)00058-1.
- Peyron C, Faraco J, Rogers W, Ripley B, Overeem S, Charnay Y, Nevsimalova S, Aldrich M, Reynolds D, Albin R, Li R, Hungs M, Pedrazzoli M, Padigaru M, Kucherlapati M, Fan J, Maki R, Lammers GJ, Bouras C, Kucherlapati R, Nishino S, Mignot E. A mutation in a case of early onset narcolepsy and a generalized absence of hypocretin peptides in human narcoleptic brains. Nat Med. 2000 Sep;6(9):991-7. doi: 10.1038/79690.
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 (实际的)
2026年8月1日
初级完成 (估计的)
2027年11月30日
研究完成 (估计的)
2027年12月1日
研究注册日期
首次提交
2026年7月12日
首先提交符合 QC 标准的
2026年7月23日
首次发布 (实际的)
2026年7月27日
研究记录更新
最后更新发布 (实际的)
2026年8月5日
上次提交的符合 QC 标准的更新
2026年8月3日
最后验证
2026年8月1日
更多信息
与本研究相关的术语
其他研究编号
- KY20262162-F-1
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
未定
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
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.