Narcolepsy Type 1
Conditions
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.
Interventions
DEVICEActive Temporal Interference Stimulation
For the active TI stimulation, the current was applied for 40 minutes per session.
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.
Sponsors
Xijing Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Years to 60 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline to week 2 in mean sleep latency from the MWT | Baseline, Week 2 |
| The incidence of adverse events and serious adverse events | Baseline, 2-week treatment period, 4-week follow-up period |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline to week 2 in Epworth Sleepiness Scale total score | Baseline, Week 2 | The Epworth Sleepiness Scale total score ranges from 0 to 24, with higher scores reflecting more severe daytime sleepiness |
| Change from baseline to week 2 in Narcolepsy Severity Scale score | 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) |
| Change from baseline to week 2 in weekly cataplexy frequency | Baseline, Week 2 | — |
| Change from baseline to weeks 1, 2, 3, and 4 following treatment in Epworth Sleepiness Scale total score | 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 |
| Change from baseline to weeks 1, 2, 3, and 4 following treatment in Narcolepsy Severity Scale score | 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) |
| Change from baseline to weeks 1, 2, 3, and 4 following treatment in weekly cataplexy frequency | Weeks 1, 2, 3 and 4 following treatment | — |
Countries
China
Contacts
CONTACTBei He
Outcome results
None listed