Temporal Interference Stimulation of Hypothalamus in Patients With Narcolepsy Type 1

Recruiting now · Not applicable · Has a placebo group

Conditions studied: Narcolepsy Type 1

In brief

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.

Key facts

Study ID

NCT07727239

Run by

Xijing Hospital

People needed

24

Starts

2026-08-01

Expected to finish

2027-12-01

Last updated by the study team

2026-08-05

Who can join

Age: 12 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Xijing Hospital — Xi'an, Shaanxi, China (enrolling)

Full record on ClinicalTrials.gov

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