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NCT07727239

Overview

NCT ID: NCT07727239
Lead Sponsor: Xijing HospitalOTHER
Official Title: Efficacy and Safety of Temporal Interference Stimulation of Hypothalamus in Patients With Narcolepsy Type 1: A Randomised, Double-blind, Sham-Controlled, Single-Centre Trial
Brief 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.
Conditions: Narcolepsy Type 1

Status and Timeline

Status: Not yet recruiting
Last Update Posted: Jul 27, 2026Actual
Start Date: Jul 2026Estimated
Primary Completion Date: Nov 2027Estimated
Completion Date

Participation Criteria

Ages Eligible for Study: Child (0-17)Adult (18-64)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
Eligibility Criteria: 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.

Study Plan

Study Type: Interventional
Phase: Not Applicable
Enrollment: 24Estimated
Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Double

Contacts and Locations

Central Contacts: Bei HeContact
1569451844@qq.com+86-29-84771377

Similar Studies

Participant Group/Arms

Active TI stimulationExperimental

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.

Device: Active Temporal Interference Stimulation

Sham TI stimulationSham Comparator

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.

Device: Sham Temporal Interference Stimulation