Temporal Interference Stimulation of Hypothalamus in Patients With Narcolepsy Type 1

NCT07727239 | Not Yet Recruiting DMC

• 1 other identifier: KY20262162-F-1
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Narcolepsy Type 1

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

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

  Baseline, Week 2

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

  Baseline, Week 2

• 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

• 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

Other Outcomes (4)

• Blinding efficacy

  Week 2

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

  Baseline, Week 2

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

  Baselien, Week 2

Study Arms (2)

Active TI stimulation

EXPERIMENTAL

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.

Device: Active Temporal Interference Stimulation

Sham TI stimulation

SHAM COMPARATOR

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.

Device: Sham Temporal Interference Stimulation

Interventions

Active Temporal Interference Stimulation DEVICE

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

Active TI stimulation

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.

Sham TI stimulation

Eligibility Criteria

• Age: 12 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xijing Hospital: lead

Study Sites (1)

Xijing Hospital

Xi'an, Shaanxi, 710032, China

Location

Related Publications (8)

• 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.

  PMID: 37857774 RESULT

• 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.

  PMID: 28575667 RESULT

• 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.

  PMID: 41232023 RESULT

• 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.

  PMID: 32197224 RESULT

• 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.

  PMID: 41355371 RESULT

• 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.

  PMID: 31324898 RESULT

• 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.

  PMID: 11055430 RESULT

• 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.

  PMID: 10973318 RESULT

Central Study Contacts

Bei He

CONTACT

+86-29-84771377; 1569451844@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2026
• First Posted: July 27, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: July 27, 2026

Record last verified: 2026-07

Locations

CN (1)