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NCT Number: NCT07727239

Temporal Interference Stimulation of Hypothalamus in Patients With Narcolepsy Type 1

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.

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Key information

Conditions

Narcolepsy Type 1

Age range

12 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Active Temporal Interference Stimulation

Device

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

Sham Temporal Interference Stimulation

Device

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.

Primary outcomes

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

    Time frame: Baseline, Week 2

  2. The incidence of adverse events and serious adverse events

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

Secondary outcomes

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

    Time frame: Baseline, Week 2

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

  2. Change from baseline to week 2 in Narcolepsy Severity Scale score

    Time frame: Baseline, Week 2

    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)

  3. Change from baseline to week 2 in weekly cataplexy frequency

    Time frame: Baseline, Week 2

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

    Time frame: Weeks 1, 2, 3, and 4 following treatment

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

  5. Change from baseline to weeks 1, 2, 3, and 4 following treatment in Narcolepsy Severity Scale score

    Time frame: Weeks 1, 2, 3 and 4 following treatment

    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)

  6. Change from baseline to weeks 1, 2, 3, and 4 following treatment in weekly cataplexy frequency

    Time frame: Weeks 1, 2, 3 and 4 following treatment

Other outcomes

  1. Blinding efficacy

    Time frame: Week 2

    Participants' subjective guess of whether they received TI (yes, no, or uncertain).

  2. Change from baseline to week 2 in sleep latency and nighttime sleep architecture derived from PSG

    Time frame: Baseline, Week 2

  3. Change from baseline to week 2 in power spectral density derived from EEG

    Time frame: Baselien, Week 2

  4. Change from baseline to week 2 in functional connectivity derived from MRI

    Time frame: Baseline, Week 2

Study contacts

Contact information is provided by the study sponsor or research team.

Bei He

CONTACT

[email protected]

+86-29-84771377

Sponsors and collaborators

Lead sponsor

Xijing Hospital

Other

Registry information

Official study 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

Acronym: TINY

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 27, 2026
Registry last updated
Jul 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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