Efficacy and Safety of Temporal Interference Stimulation of Hypothalamus in Patients With Narcolepsy Type 1: A Randomised, Double-blind, Sham-Controlled, Single-Centre Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- The incidence of adverse events and serious adverse events
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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-
- •Epworth Sleepiness Scale score >12 at baseline.
- •Signed informed consent.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Sham Temporal Interference Stimulation (Device)
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.
干预措施: Active Temporal Interference Stimulation (Device)
结局指标
主要结局
The incidence of adverse events and serious adverse events
时间窗: Baseline, 2-week treatment period, 4-week follow-up period
Change from baseline to week 2 in mean sleep latency from the MWT
时间窗: Baseline, Week 2
次要结局
- Change from baseline to weeks 1, 2, 3, and 4 following treatment in weekly cataplexy frequency(Weeks 1, 2, 3 and 4 following treatment)
- Change from baseline to week 2 in Epworth Sleepiness Scale total score(Baseline, Week 2)
- Change from baseline to week 2 in Narcolepsy Severity Scale score(Baseline, Week 2)
- Change from baseline to week 2 in weekly cataplexy frequency(Baseline, Week 2)
- Change from baseline to weeks 1, 2, 3, and 4 following treatment in Epworth Sleepiness Scale total score(Weeks 1, 2, 3, and 4 following treatment)
- Change from baseline to weeks 1, 2, 3, and 4 following treatment in Narcolepsy Severity Scale score(Weeks 1, 2, 3 and 4 following treatment)