Narcolepsy Type 1TINYNCT07727239
Temporal Interference Stimulation of Hypothalamus in Patients With Narcolepsy Type 1
A study testing Active Temporal Interference Stimulation in people with Narcolepsy Type 1, run by Xijing Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 60 years
- Conditions the study is for
- Narcolepsy Type 1
- What is being tested?
- Active Temporal Interference Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2026to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Xijing Hospital
Xi'an, Shaanxi, 710032
Wen Tian Gao, +86-29-84771794, customer@notice.rh-clinical.com
About this study
Official 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
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
- Being tested
- Active Temporal Interference Stimulation, Sham Temporal Interference Stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active Temporal Interference StimulationDevice
For the active TI stimulation, the current was applied for 40 minutes per session.
Sham Temporal Interference StimulationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Sham Temporal Interference Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline to week 2 in mean sleep latency from the MWT
Measured: Baseline, Week 2
The incidence of adverse events and serious adverse events
Measured: 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
The Epworth Sleepiness Scale total score ranges from 0 to 24, with higher scores reflecting more severe daytime sleepiness
Measured: 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)
Measured: Baseline, Week 2
Change from baseline to week 2 in weekly cataplexy frequency
Measured: 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
Measured: 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
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)
Measured: Weeks 1, 2, 3 and 4 following treatment
Change from baseline to weeks 1, 2, 3, and 4 following treatment in weekly cataplexy frequency
Measured: Weeks 1, 2, 3 and 4 following treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2026
- Study start1 Aug 2026
- Primary completion30 Nov 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Narcolepsy Type 1Studies of the same condition, open and under way.
- More trials run by Xijing HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07727239
- Sponsor's protocol ID
- KY20262162-F-1
- Acronym
- TINY
- Status last verified
- Aug 2026
- First submitted
- 12 Jul 2026
- Last updated
- 5 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 37857774Grossman 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.
PubMed 28575667Xu 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.
PubMed 41232023Perez-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.
PubMed 32197224Hastings 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.
PubMed 41355371Bassetti 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.
PubMed 31324898Thannickal 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.
PubMed 11055430Peyron 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.
PubMed 10973318
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07727239
- Acronym / sponsor ID
- TINY / KY20262162-F-1
- Conditions
- Narcolepsy Type 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- 1 Aug 2026 (actual)
- Primary completion
- 30 Nov 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 27 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active TI stimulation | Experimental | Device: Active Temporal Interference StimulationParticipants 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. |
| Sham TI stimulation | Sham comparator | Device: Sham Temporal Interference StimulationParticipants 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. |
Who may qualify
- Ages
- 12 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active Temporal Interference StimulationFor the active TI stimulation, the current was applied for 40 minutes per session. | Device | Active TI stimulation |
| Sham Temporal Interference StimulationFor 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. | Device | Sham TI stimulation |
Primary outcome
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
6 secondary outcomes
Change from baseline to week 2 in Epworth Sleepiness Scale total score
Time frame: Baseline, Week 2
Change from baseline to week 2 in Narcolepsy Severity Scale score
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
Time frame: 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
Time frame: Weeks 1, 2, 3 and 4 following treatment
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2026.
- Results publication: PubMed 37857774Wessel 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.
- Results publication: PubMed 28575667Grossman 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.
- Results publication: PubMed 41232023Xu 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.
- Results publication: PubMed 32197224Perez-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.
- Results publication: PubMed 41355371Hastings 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.
- Results publication: PubMed 31324898Bassetti 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.
- Results publication: PubMed 11055430Thannickal 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.
- Results publication: PubMed 10973318Peyron 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active Temporal Interference Stimulation in people with Narcolepsy Type 1, run by Xijing Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bei He (+86-29-84771377, 1569451844@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline to week 2 in mean sleep latency from the MWT (time frame: Baseline, Week 2). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07727239, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2026.