Temporal Interference Stimulation of Hypothalamus in Patients With Narcolepsy Type 1

ConditionNarcolepsy Type 1

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age12-60

SponsorXijing Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

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.

Treatment groups

24 Participants

are divided into 2 treatment groups

Group A: Active TI stimulationExperimental treatment 1 intervention

Group B: Sham TI stimulationSham comparator 1 intervention

Trial 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

Other outcomes

Blinding efficacy

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

Time frame

Week 2

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

Time frame

Baseline, Week 2

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

Time frame

Baselien, Week 2

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

Time frame

Baseline, Week 2

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Xijing Hospital

Lead sponsor

Source ClinicalTrials.gov

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