Active Temporal Interference StimulationSham Temporal Interference Stimulation
Active Temporal Interference Stimulation: For the active TI stimulation, the current was applied for 40 minutes per session.
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.
Study summary
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.
Eligibility
Sex
ALL
Min age
12 Years
Max age
60 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
Change from baseline to week 2 in mean sleep latency from the MWT — Baseline, Week 2
The incidence of adverse events and serious adverse events — Baseline, 2-week treatment period, 4-week follow-up period
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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