Temporal interference stimulation for narcolepsy type 1

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, double-blind study tests a theta-burst temporal interference protocol aimed at modulating deep brain activity in the hypothalamus for narcolepsy type 1. Participants receive active or sham TI stimulation and are evaluated for changes in daytime sleepiness and related symptoms. The study includes individuals aged 12 to 60 who meet diagnostic criteria and have moderate daytime sleepiness, with safety monitoring for MRI and stimulation-related risks. Results from this trial may indicate whether TI stimulation is a feasible treatment approach for NT1.

Why it matters

Who can join: the full rules

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.

Where it's running

• Xijing Hospital
  Xi'an, Shaanxi, China Recruiting

Study contacts

• Study coordinator: Bei He
• Email: 1569451844@qq.com
• Phone: +86-29-84771377

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.