Temporal Interference Stimulation of Hypothalamus in Patients With Narcolepsy Type 1

Официальное название

Efficacy and Safety of Temporal Interference Stimulation of Hypothalamus in Patients With Narcolepsy Type 1: A Randomised, Double-blind, Sham-Controlled, Single-Centre Trial

Обзор

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.

Вмешательства

• Устройство Active Temporal Interference Stimulation
  For the active TI stimulation, the current was applied for 40 minutes per session.
• Устройство Sham Temporal Interference Stimulation
  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.

Первичные конечные точки

• Change from baseline to week 2 in mean sleep latency from the MWT [Срок оценки: Baseline, Week 2]
• The incidence of adverse events and serious adverse events [Срок оценки: Baseline, 2-week treatment period, 4-week follow-up period]

Вторичные конечные точки (6)

• Change from baseline to week 2 in Epworth Sleepiness Scale total score [Срок оценки: Baseline, Week 2]
• Change from baseline to week 2 in Narcolepsy Severity Scale score [Срок оценки: Baseline, Week 2]
• Change from baseline to week 2 in weekly cataplexy frequency [Срок оценки: Baseline, Week 2]
• Change from baseline to weeks 1, 2, 3, and 4 following treatment in Epworth Sleepiness Scale total score [Срок оценки: 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 [Срок оценки: Weeks 1, 2, 3 and 4 following treatment]
• Change from baseline to weeks 1, 2, 3, and 4 following treatment in weekly cataplexy frequency [Срок оценки: Weeks 1, 2, 3 and 4 following treatment]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Xijing Hospital — Сиань

Публикации

• 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. PMID 37857774
• 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. PMID 28575667
• 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. PMID 41232023
• 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. PMID 32197224
• 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. PMID 41355371
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• 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: PMID 10973318

Идентификаторы

NCT: NCT07727239 · KY20262162-F-1

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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