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Acute Ischemic StrokeTIMESNCT07896629

Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke

A study testing Transcranial Temporal Interference Stimulation (tTIs) in people with Acute Ischemic Stroke, run by Xuanwu Hospital, Beijing at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

This study aims to test whether transcranial temporal interference stimulation (tTIs) can improve upper limb motor function in patients in the early subacute stage after acute ischemic stroke. Participants will be randomly assigned to receive either active tTIs treatment or sham stimulation. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Acute Ischemic Stroke
What is being tested?
Transcranial Temporal Interference Stimulation (tTIs)
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
60 participants
Where
1 siteChina
Study dates
Nov 2026to Feb 2028
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 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • First-ever ischemic stroke occurring 7 days to 3 months before enrollment.
  • Unilateral anterior-circulation ischemic stroke confirmed by CT or MRI.
  • Receipt of reperfusion therapy.
  • Age 18-80 years.
  • Upper-limb motor impairment, defined as an FMA-UE score of ≤42.
  • Right-handedness, as determined by the Edinburgh Handedness Inventory.
  • Ability to understand and communicate adequately, willingness to participate, and provision of written informed consent.

Who cannot join

  • Previous history of stroke, either ischemic or hemorrhagic.
  • Severe cognitive impairment or psychiatric symptoms.
  • Bilateral brain lesions or other neurological disorders, including Parkinson's disease, epilepsy, or brain tumors.
  • Severe cardiac, pulmonary, hepatic, renal, or other major organ dysfunction.
  • Skull defects.
  • Increased intracranial pressure.
Show all 10Show fewer
  • Contraindications to MRI, including incompatible intracranial or external metal objects or implanted devices such as pacemakers or infusion pumps.
  • Current participation in another clinical trial.
  • Inability to complete the treatment or follow-up procedures, poor adherence, or adverse reactions to electrical stimulation that prevent continued participation.
  • Pregnancy or breastfeeding.

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
  • Xuanwu Hospital, Capital Medical University

    Beijing, 100053

    Cong Fu, 010-83199060, fucong666@yeah.net

    Liqun Jiao

Other trials in China

About this study

Official title: Effects of Transcranial Temporal Interference Stimulation on Upper-Limb Motor Recovery in Early Subacute Ischemic Stroke: A Randomized, Double-Blind, Sham-Controlled Pilot Trial

This study aims to test whether transcranial temporal interference stimulation (tTIs) can improve upper limb motor function in patients in the early subacute stage after acute ischemic stroke. Participants will be randomly assigned to receive either active tTIs treatment or sham stimulation. All subjects will receive routine rehabilitation. The treatment will be given once daily for 20 consecutive days. Researchers will assess upper limb motor function before treatment, during the intervention and after the treatment course to compare the effect between the two groups. Safety will also be monitored throughout the study.

Read the detailed description

This prospective, two-center, randomized, double-blind, parallel-group, exploratory pilot randomized controlled trial will enroll 60 right-handed patients with first-ever unilateral anterior circulation acute ischemic stroke in the early subacute phase (7 days to 3 months after stroke onset). All participants will have received reperfusion therapy and exhibit upper-limb motor impairment, defined as a Fugl-Meyer Assessment of the Upper Extremity (FMA-UE) score of ≤42. Participants will be randomly assigned in a 1:1 ratio to either the active tTIS group or the sham-stimulation group.All participants will receive standard rehabilitation therapy once daily for 20 consecutive days. In addition to routine rehabilitation, participants in the active tTIS group will receive active stimulation targeting the cerebellar dentate nucleus. Participants in the sham group will undergo an identical setup, including EEG cap placement, but will receive sham stimulation without effective amplitude-modulated output. Each stimulation session will last 20 minutes. Participants and outcome assessors will be blinded to group allocation, whereas the treatment operator will remain unblinded. Blinding will be maintained until the database is locked.

Assessments will be conducted at baseline, immediately before and after the first intervention session, on days 7 and 14, after completion of the 20-session intervention, and at the 3-month follow-up. Clinical assessments, multimodal magnetic resonance imaging (MRI), electroencephalography (EEG), and transcranial magnetic stimulation (TMS) examinations will be performed at prespecified time points to characterize changes in motor function, brain structural and functional connectivity, and cortical excitability. Adverse events will be systematically recorded and monitored throughout the trial.

This study aims to investigate the safety and feasibility of cerebellar dentate nucleus-targeted tTIS as an adjunct to routine rehabilitation and to obtain preliminary evidence of its efficacy in improving upper-limb motor function in patients with acute ischemic stroke during the early subacute phase. In addition, multimodal neuroimaging and neurophysiological assessments will be used to explore the potential neural mechanisms underlying tTIS-induced motor recovery.

Being tested
Transcranial Temporal Interference Stimulation (tTIs), Sham Transcranial Temporal Interference Stimulation (Sham tTIs)
Keywords
Acute ischemic stroke, Transcranial temporal interference stimulation, Upper-limb motor recovery, Cerebellar dentate nucleus, Randomized controlled trial
Medical subject headings
Ischemic Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Transcranial Temporal Interference Stimulation (tTIs)Device

    Individualized active stimulation will be administered via the NervioX-1000 temporal interference stimulation system. The cerebellar dentate nucleus contralateral to the cerebral lesion is targeted using an electrode montage and current ratio optimized based on each participant's structural magnetic resonance imaging and finite-element electric field modeling. Stimulation parameters are kept constant throughout the intervention. Each session lasts 20 minutes, including 30-second ramp-up and ramp-down periods, with treatment administered once daily for 20 consecutive days.

  • Sham Transcranial Temporal Interference Stimulation (Sham tTIs)Device

    Sham stimulation will be delivered using the same device, individualized electrode montage, positioning procedures, and session schedule as active stimulation. The device will reproduce the initial ramp-up and brief stimulation sensations and will then ramp down without delivering sustained active stimulation. A brief terminal ramp will reproduce end-of-session sensations. Each sham session lasts 20 minutes, including 30-second ramp-up and ramp-down periods, administered once daily for 20 consecutive days.

Study groups in NCT07896629
Study groupRoleWhat they receive
Active tTIs GroupExperimentalParticipants will receive individualized active transcranial temporal interference stimulation targeting the cerebellar dentate nucleus contralateral to the cerebral lesion, 20 minutes per session, once daily for 20 consecutive days, combined with routine rehabilitation therapy.
Receives: Device: Transcranial Temporal Interference Stimulation (tTIs)
Sham tTIs GroupSham comparatorParticipants will receive sham transcranial temporal interference stimulation followed by the same standardized routine rehabilitation therapy. The sham procedure will use the same device, electrode montage, session duration, and ramp sensations as active stimulation but will not deliver sustained active stimulation.
Receives: Device: Sham Transcranial Temporal Interference Stimulation (Sham tTIs)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Fugl-Meyer Assessment of Upper Extremity (FMA-UE)

    Change in Fugl-Meyer Assessment of Upper Extremity score, range 0-66; higher score indicates better upper limb motor function.

    Measured: 20 days after the start of intervention

Secondary outcomes (6)
  1. Action Research Arm Test (ARAT)

    The Action Research Arm Test scale is used to assess upper limb activity and functional ability. Total possible scores range from 0 to 57. Higher scores indicate better upper limb functional performance.

    Measured: 20 days after the start of intervention

  2. Global disability: Modified Rankin Scale (mRS)

    The Modified Rankin Scale is an ordinal scale used to assess functional disability and dependence in activities of daily living after stroke. Scores range from 0 to 6. Higher scores indicate worse functional outcome, with a score of 6 representing death.

    Measured: 20 days after the start of intervention

  3. National Institutes of Health Stroke Scale (NIHSS)

    The National Institutes of Health Stroke Scale is used to quantify neurological deficit after stroke. Total possible scores range from 0 to 42. Higher scores indicate more severe neurological impairment (worse outcome).

    Measured: 20 days after the start of intervention

  4. Multimodal magnetic resonance imaging (MRI)

    Multimodal MRI, including functional MRI (fMRI), diffusion tensor imaging (DTI), and three-dimensional T1-weighted imaging, is acquired to assess structural-functional coupling of the dentato-thalamo-cortical (DTC) pathway. Structural-functional connectivity (SFC) is calculated as the coupling index between DTI-derived structural connectivity and resting-state fMRI functional connectivity along the DTC pathway. Higher SFC values indicate stronger structural-functional coupling of this pathway.

    Measured: Assessments were performed at 1 and 20 days after the initiation of the intervention

  5. Electroencephalography (EEG)

    EEG is recorded synchronously during temporal interference (TI) stimulation. Inter-trial phase coherence (ITPC) is computed to quantify the consistency of phase-locked cortical responses across trials, ranging from 0 to 1. Higher ITPC indicates more reliable phase-locked cortical activation.

    Measured: Assessments were performed at 1 and 20 days after the initiation of the intervention

  6. Transcranial Magnetic Stimulation (TMS)-Induced Motor Evoked Potentials (MEP)

    Single-pulse transcranial magnetic stimulation (TMS) is delivered over the primary motor cortex. Surface electromyography records motor evoked potentials from the target muscle. Peak-to-peak MEP amplitude is measured in microvolts (μV). Larger amplitude indicates higher corticospinal excitability.

    Measured: Assessments were performed at 1 and 20 days after the initiation of the intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Oct 2026
  2. Study startNov 2026 (estimated)
  3. Primary completionNov 2027 (estimated)
  4. Study completionFeb 2028 (estimated)

Resources

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
Model description
Participants are randomly allocated at a 1:1 ratio into two parallel groups: active tTIs stimulation group and sham stimulation group.
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07896629
Sponsor's protocol ID
TIMES
Acronym
TIMES
Status last verified
Oct 2026
First submitted
19 Oct 2026
Last updated
27 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data (IPD) will not be shared. The data involves sensitive personal health information of participants, and there is no plan to release the individual-level raw data to other researchers due to privacy and data security considerations.

Publications

  • Gopalakrishnan R, Cunningham DA, Hogue O, Schroedel M, Campbell BA, Plow EB, Baker KB, Machado AG. Cortico-Cerebellar Connectivity Underlying Motor Control in Chronic Poststroke Individuals. J Neurosci. 2022 Jun 29;42(26):5186-5197. doi: 10.1523/JNEUROSCI.2443-21.2022.

    PubMed 35610051
  • Wathen CA, Frizon LA, Maiti TK, Baker KB, Machado AG. Deep brain stimulation of the cerebellum for poststroke motor rehabilitation: from laboratory to clinical trial. Neurosurg Focus. 2018 Aug;45(2):E13. doi: 10.3171/2018.5.FOCUS18164.

    PubMed 30064319
  • Machado A, Baker KB. Upside down crossed cerebellar diaschisis: proposing chronic stimulation of the dentatothalamocortical pathway for post-stroke motor recovery. Front Integr Neurosci. 2012 May 21;6:20. doi: 10.3389/fnint.2012.00020. eCollection 2012.

    PubMed 22661933
  • Baker KB, Plow EB, Nagel S, Rosenfeldt AB, Gopalakrishnan R, Clark C, Wyant A, Schroedel M, Ozinga J 4th, Davidson S, Hogue O, Floden D, Chen J, Ford PJ, Sankary L, Huang X, Cunningham DA, DiFilippo FP, Hu B, Jones SE, Bethoux F, Wolf SL, Chae J, Machado AG. Cerebellar deep brain stimulation for chronic post-stroke motor rehabilitation: a phase I trial. Nat Med. 2023 Sep;29(9):2366-2374. doi: 10.1038/s41591-023-02507-0. Epub 2023 Aug 14.

    PubMed 37580534
  • He L, Wei Y, Gao C, Qiu S, Liu T, Gao Q. Magnetic Resonance Imaging-Guided Temporal Interference Stimulation of the Cerebellar Fastigial Nucleus in Stroke Patients for Balance. J Vis Exp. 2026 May 15;(231). doi: 10.3791/70982.

    PubMed 42224112
  • Bonni S, Motta C, Pellicciari MC, Casula EP, Cinnera AM, Maiella M, Picazio S, Tramontano M, Sallustio F, Koch G. Intermittent Cerebellar Theta Burst Stimulation Improves Visuo-motor Learning in Stroke Patients: a Pilot Study. Cerebellum. 2020 Oct;19(5):739-743. doi: 10.1007/s12311-020-01146-2.

    PubMed 32462496
  • Liao LY, Zhu Y, Peng QY, Gao Q, Liu L, Wang QH, Gao SH, Tao Y, Huang H, Xu PD, Gao CY. Intermittent Theta-Burst Stimulation for Stroke: Primary Motor Cortex Versus Cerebellar Stimulation: A Randomized Sham-Controlled Trial. Stroke. 2024 Jan;55(1):156-165. doi: 10.1161/STROKEAHA.123.044892. Epub 2023 Nov 30.

    PubMed 38037225
  • Li X, Baker KB, O'Laughlin K, Chen J, Hogue O, Machado AG, Plow EB. Paired DBS and TMS Reveals Dentato-Cortical Facilitation Underlying Upper Extremity Movement in Chronic Stroke Survivors. Neurorehabil Neural Repair. 2024 Feb;38(2):109-121. doi: 10.1177/15459683231219265. Epub 2023 Dec 29.

    PubMed 38156644
  • Machado AG, Baker KB, Schuster D, Butler RS, Rezai A. Chronic electrical stimulation of the contralesional lateral cerebellar nucleus enhances recovery of motor function after cerebral ischemia in rats. Brain Res. 2009 Jul 14;1280:107-16. doi: 10.1016/j.brainres.2009.05.007. Epub 2009 May 12.

    PubMed 19445910

Questions about this trial

What is this clinical trial studying?

A study testing Transcranial Temporal Interference Stimulation (tTIs) in people with Acute Ischemic Stroke, run by Xuanwu Hospital, Beijing 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 7 inclusion and 10 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: opening soon, as of the sponsor's last update on 27 Oct 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 Cong Fu (010-83199060, fucong666@yeah.net), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Fugl-Meyer Assessment of Upper Extremity (FMA-UE) (time frame: 20 days after the start of intervention). 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 NCT07896629, which also lists 9 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 27 Oct 2026.

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