An interventional study of Transcranial Temporal Interference Stimulation (tTIs) and Sham Transcranial Temporal Interference Stimulation (Sham tTIs) in Acute Ischemic Stroke, sponsored by Xuanwu Hospital, Beijing. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-11-06.
Sponsored by Xuanwu Hospital, Beijing · Not applicable, Interventional, and Treatment
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.
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.
2,612 studies on the registry are indexed under Ischemic Stroke; 971 are open to participants now.
This study's planned enrollment of 60 is below the median of 120 across 1,776 interventional studies indexed under Ischemic Stroke.
Browse Ischemic Stroke studies →Xuanwu Hospital, Beijing is the lead sponsor of 363 studies on the registry; 230 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants 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.
Device: Transcranial Temporal Interference Stimulation (tTIs)
Participants 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.
Device: Sham Transcranial Temporal Interference Stimulation (Sham tTIs)
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 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.
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.
Time frame: 20 days after the start of intervention
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.
Time frame: 20 days after the start of intervention
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.
Time frame: 20 days after the start of intervention
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).
Time frame: 20 days after the start of intervention
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.
Time frame: Assessments were performed at 1 and 20 days after the initiation of the intervention
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.
Time frame: Assessments were performed at 1 and 20 days after the initiation of the intervention
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.
Time frame: Assessments were performed at 1 and 20 days after the initiation of the intervention
adverse events
The incidence and severity of adverse events, including adverse events related to the intervention, assessed throughout the intervention period.
Time frame: 20 days after the start of intervention
Plan to share: 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.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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