Temporal Interference Stimulation of Hypothalamus in Patients With Narcolepsy Type 1 (TINY)
3. august 2026 oppdatert av: Xijing Hospital
Efficacy and Safety of Temporal Interference Stimulation of Hypothalamus in Patients With Narcolepsy Type 1: A Randomised, Double-blind, Sham-Controlled, Single-Centre 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.
Studieoversikt
Status
Rekruttering
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Antatt)
24
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Bei He
- Telefonnummer: +86-29-84771377
- E-post: 1569451844@qq.com
Studiesteder
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Shaanxi
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Xi'an, Shaanxi, Kina, 710032
- Rekruttering
- Xijing Hospital
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Ta kontakt med:
- Wen Tian Gao
- Telefonnummer: +86-29-84771794
- E-post: customer@notice.rh-clinical.com
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
- Voksen
Tar imot friske frivillige
Nei
Beskrivelse
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.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: Active TI stimulation
Participants will receive twice-daily TI stimulation, administered 4 hours apart or more, for 2 weeks.
The current will be applied for 40 minutes per session.
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For the active TI stimulation, the current was applied for 40 minutes per session.
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Sham-komparator: Sham TI stimulation
Participants will receive twice-daily TI stimulation, administered 4 hours apart or more, for 2 weeks.
Each session is scheduled for 40 minutes, but actual current is delivered only as a short 30-second pulse at the start and at the end, with no current applied in between.
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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.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Change from baseline to week 2 in mean sleep latency from the MWT
Tidsramme: Baseline, Week 2
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Baseline, Week 2
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The incidence of adverse events and serious adverse events
Tidsramme: Baseline, 2-week treatment period, 4-week follow-up period
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Baseline, 2-week treatment period, 4-week follow-up period
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Change from baseline to week 2 in Epworth Sleepiness Scale total score
Tidsramme: Baseline, Week 2
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The Epworth Sleepiness Scale total score ranges from 0 to 24, with higher scores reflecting more severe daytime sleepiness
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Baseline, Week 2
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Change from baseline to week 2 in Narcolepsy Severity Scale score
Tidsramme: Baseline, Week 2
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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)
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Baseline, Week 2
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Change from baseline to week 2 in weekly cataplexy frequency
Tidsramme: Baseline, Week 2
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Baseline, Week 2
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Change from baseline to weeks 1, 2, 3, and 4 following treatment in Epworth Sleepiness Scale total score
Tidsramme: Weeks 1, 2, 3, and 4 following treatment
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The Epworth Sleepiness Scale total score ranges from 0 to 24, with higher scores reflecting more severe daytime sleepiness
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Weeks 1, 2, 3, and 4 following treatment
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Change from baseline to weeks 1, 2, 3, and 4 following treatment in Narcolepsy Severity Scale score
Tidsramme: 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)
|
Weeks 1, 2, 3 and 4 following treatment
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Change from baseline to weeks 1, 2, 3, and 4 following treatment in weekly cataplexy frequency
Tidsramme: Weeks 1, 2, 3 and 4 following treatment
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Weeks 1, 2, 3 and 4 following treatment
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Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Blinding efficacy
Tidsramme: Week 2
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Participants' subjective guess of whether they received TI (yes, no, or uncertain).
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Week 2
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Change from baseline to week 2 in sleep latency and nighttime sleep architecture derived from PSG
Tidsramme: Baseline, Week 2
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Baseline, Week 2
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Change from baseline to week 2 in power spectral density derived from EEG
Tidsramme: Baselien, Week 2
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Baselien, Week 2
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Change from baseline to week 2 in functional connectivity derived from MRI
Tidsramme: Baseline, Week 2
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Baseline, Week 2
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- Grossman N, Bono D, Dedic N, Kodandaramaiah SB, Rudenko A, Suk HJ, Cassara AM, Neufeld E, Kuster N, Tsai LH, Pascual-Leone A, Boyden ES. Noninvasive Deep Brain Stimulation via Temporally Interfering Electric Fields. Cell. 2017 Jun 1;169(6):1029-1041.e16. doi: 10.1016/j.cell.2017.05.024.
- Wessel MJ, Beanato E, Popa T, Windel F, Vassiliadis P, Menoud P, Beliaeva V, Violante IR, Abderrahmane H, Dzialecka P, Park CH, Maceira-Elvira P, Morishita T, Cassara AM, Steiner M, Grossman N, Neufeld E, Hummel FC. Noninvasive theta-burst stimulation of the human striatum enhances striatal activity and motor skill learning. Nat Neurosci. 2023 Nov;26(11):2005-2016. doi: 10.1038/s41593-023-01457-7. Epub 2023 Oct 19.
- Xu S, Cui H, Xiao X, Manshaii F, Hong G, Chen J. Precision at Deep Brain: Noninvasive Temporal Interference Stimulation. ACS Nano. 2025 Nov 25;19(46):39589-39614. doi: 10.1021/acsnano.5c15238. Epub 2025 Nov 13.
- Perez-Carbonell L, Lyons E, Gnoni V, Higgins S, Otaiku AI, Leschziner GD, Drakatos P, d'Ancona G, Kent BD. Adherence to wakefulness promoting medication in patients with narcolepsy. Sleep Med. 2020 Jun;70:50-54. doi: 10.1016/j.sleep.2020.02.013. Epub 2020 Feb 26.
- Hastings NE, Abdi KE, Bibi F, Aslam B, Nunez MR, Sherani MTR, Shadmani S, Alam U, Hassan VM, Hoor-E-Ainaa, Imran H, Hanna J, Sadat SH. Narcolepsy: Pathophysiology, Diagnosis, Management, and Future Directions, a Narrative Review. Brain Behav. 2025 Dec;15(12):e71116. doi: 10.1002/brb3.71116.
- Bassetti CLA, Adamantidis A, Burdakov D, Han F, Gay S, Kallweit U, Khatami R, Koning F, Kornum BR, Lammers GJ, Liblau RS, Luppi PH, Mayer G, Pollmacher T, Sakurai T, Sallusto F, Scammell TE, Tafti M, Dauvilliers Y. Narcolepsy - clinical spectrum, aetiopathophysiology, diagnosis and treatment. Nat Rev Neurol. 2019 Sep;15(9):519-539. doi: 10.1038/s41582-019-0226-9. Epub 2019 Jul 19.
- Thannickal TC, Moore RY, Nienhuis R, Ramanathan L, Gulyani S, Aldrich M, Cornford M, Siegel JM. Reduced number of hypocretin neurons in human narcolepsy. Neuron. 2000 Sep;27(3):469-74. doi: 10.1016/s0896-6273(00)00058-1.
- Peyron C, Faraco J, Rogers W, Ripley B, Overeem S, Charnay Y, Nevsimalova S, Aldrich M, Reynolds D, Albin R, Li R, Hungs M, Pedrazzoli M, Padigaru M, Kucherlapati M, Fan J, Maki R, Lammers GJ, Bouras C, Kucherlapati R, Nishino S, Mignot E. A mutation in a case of early onset narcolepsy and a generalized absence of hypocretin peptides in human narcoleptic brains. Nat Med. 2000 Sep;6(9):991-7. doi: 10.1038/79690.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
1. august 2026
Primær fullføring (Antatt)
30. november 2027
Studiet fullført (Antatt)
1. desember 2027
Datoer for studieregistrering
Først innsendt
12. juli 2026
Først innsendt som oppfylte QC-kriteriene
23. juli 2026
Først lagt ut (Faktiske)
27. juli 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
5. august 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
3. august 2026
Sist bekreftet
1. august 2026
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- KY20262162-F-1
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