Temporal Interference Stimulation of Hypothalamus in Patients With Narcolepsy Type 1

Xijing Hospital24 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Narcolepsy Type 1

Interventions

Active Temporal Interference StimulationDEVICE

For the active TI stimulation, the current was applied for 40 minutes per session.

Sham Temporal Interference StimulationDEVICE

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.

Eligibility

Sex: ALLMin age: 12 YearsMax age: 60 Years

Medical Language ↔ Plain English

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.

Locations (1)

Xijing Hospital

Xi'an, Shaanxi, China

RECRUITING

Outcomes

Primary Outcomes

Change from baseline to week 2 in mean sleep latency from the MWT

Time frame: Baseline, Week 2

The incidence of adverse events and serious adverse events

Time frame: Baseline, 2-week treatment period, 4-week follow-up period

Secondary Outcomes

Change from baseline to week 2 in Epworth Sleepiness Scale total score

The Epworth Sleepiness Scale total score ranges from 0 to 24, with higher scores reflecting more severe daytime sleepiness

Time frame: Baseline, Week 2

Change from baseline to week 2 in Narcolepsy Severity Scale score

The Narcolepsy Severity Scale score comprises 15 items assessing the frequency and severity of excessive daytime sleepiness, cataplexy, hypnagogic hallucinations, sleep paralysis, and disrupted nighttime sleep (total score 0-57, higher scores indicating greater severity)

Time frame: Baseline, Week 2

Change from baseline to week 2 in weekly cataplexy frequency

Time frame: Baseline, Week 2

Change from baseline to weeks 1, 2, 3, and 4 following treatment in Epworth Sleepiness Scale total score

The Epworth Sleepiness Scale total score ranges from 0 to 24, with higher scores reflecting more severe daytime sleepiness

Time frame: 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

Central Contacts

Bei He

CONTACT

+86-29-84771377 1569451844@qq.com

Data from ClinicalTrials.gov

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