An interventional study of Transcranial Temporal Interference Stimulation (tTIS) and Sham tTIS in Acute Ichemic Stroke, sponsored by The First Affiliated Hospital of Bengbu Medical University. Enrolling by invitation at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-11-03.
Sponsored by The First Affiliated Hospital of Bengbu Medical University · Not applicable, Interventional, and Treatment
This trial enrolls patients with acute ischemic stroke. The key inclusion criteria are: patient age 18-80 years, within 72 hours of symptom onset, National Institutes of Health Stroke Scale (NIHSS) score of 4-24, motor dysfunction score of one upper and lower limb ≥ 4, and pre-stroke modified Rankin Scale (mRS) 0-2. Subjects will be randomized in a 1:1 ratio.
In addition to standard treatment, the intervention group (real stimulation group) will wear a non-invasive multi-channel electrode cap, typically using 16 channels, after MRI navigation and positioning. The device achieves focused stimulation of deep targets through current interference between multiple electrode pairs. This will be performed once daily for 30 minutes per session, with 10 days as one treatment course.
The control group (sham stimulation group) will use the same equipment and electrode cap. The stimulator will only apply weak current during the initial 30 seconds and the 30 seconds before the end to simulate the skin sensation of real stimulation, with no effective current output for the majority of the remaining time. This mode has been proven to effectively maintain the blinding of subjects and assessors.
Efficacy evaluation endpoints:
This trial enrolls patients with acute ischemic stroke. The key inclusion criteria are: patient age 18-80 years, within 72 hours of symptom onset, National Institutes of Health Stroke Scale (NIHSS) score of 4-24, motor dysfunction score of one upper and lower limb ≥ 4, and pre-stroke modified Rankin Scale (mRS) 0-2. Subjects will be randomized in a 1:1 ratio.
In addition to standard treatment, the intervention group (real stimulation group) will wear a non-invasive multi-channel electrode cap, typically using 16 channels, after MRI navigation and positioning. The device achieves focused stimulation of deep targets through current interference between multiple electrode pairs. This will be performed once daily for 30 minutes per session, with 10 days as one treatment course.
The control group (sham stimulation group) will use the same equipment and electrode cap. The stimulator will only apply weak current during the initial 30 seconds and the 30 seconds before the end to simulate the skin sensation of real stimulation, with no effective current output for the majority of the remaining time. This mode has been proven to effectively maintain the blinding of subjects and assessors.
Efficacy evaluation endpoints:
Analyses of the primary and secondary outcomes will be conducted according to the intention-to-treat (ITT) principle. Logistic regression will be used to analyze the difference in the proportion of patients with a 90-day mRS score of 0-2 between the two groups. The distribution of mRS scores will be analyzed using ordinal logistic regression. Subgroup analyses will be performed using logistic regression to compare interaction effects across subgroups. All hypothesis tests will be conducted with α=0.05 (two-sided).
8,255 studies on the registry are indexed under Stroke; 2,056 are open to participants now.
This study's planned enrollment of 378 is above the median of 49 across 6,024 interventional studies indexed under Stroke.
Browse Stroke studies →The First Affiliated Hospital of Bengbu Medical University is the lead sponsor of 18 studies on the registry; 13 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
1. Hemorrhagic stroke or history of stroke with severe residual disability; 2. Presence of intracranial or cranial metal or electronic implants, cardiac pacemaker, or severe skull defect; 3. Skin injury/inflammation at the stimulation site; 4. History of epilepsy or high risk of inducing seizures during stimulation; 5. Systolic blood pressure > 170 mmHg and/or diastolic blood pressure > 100 mmHg; 6. Severe impairment of vital organs such as heart and lungs, and severe hepatic and renal insufficiency; 7. History of psychiatric disorders or inability to cooperate with treatment; 8. Any condition that, in the investigator's judgment, may pose a hazard to the patient or affect the patient's participation in the study if study treatment is initiated; 9. Participation in other interventional clinical trials within the past 3 months; 10. Pregnant or lactating women, or those unwilling to take effective measures during the trial.
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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.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Intervention Group (Active Stimulation Group): After MRI-guided localization, participants will wear a non-invasive multi-channel electrode cap, typically with 16 channels. Focused stimulation of deep brain targets is achieved through current interference between multiple electrode pairs. The intervention will be administered once daily for 30 minutes per session, with 10 consecutive days as one treatment course.
Device: Transcranial Temporal Interference Stimulation (tTIS)
Participants will use the identical device and electrode cap. The stimulator will apply a weak current only during the initial 30 seconds and the final 30 seconds of each session to mimic the cutaneous sensations of active stimulation. No effective current will be delivered during the remainder of the session.
Device: Sham tTIS
Transcranial temporal interference stimulation (tTIS) is delivered via a non-invasive multi-channel electrode cap (typically 16 channels). MRI-guided target localization is used to achieve focused deep brain stimulation through multi-electrode current interference. For the active stimulation condition, the intervention is administered once daily for 30 minutes per session, for a total of 10 days (one treatment course). For the sham condition, the identical device and cap are used, but the stimulator is turned on briefly (for 30 seconds at the start and end) to mimic cutaneous sensations, with no effective current output during the remainder of the session.
Participants will use the identical device and electrode cap. The stimulator will apply a weak current only during the initial 30 seconds and the final 30 seconds of each session to mimic the cutaneous sensations of active stimulation. No effective current will be delivered during the remainder of the session.
Proportion of subjects with modified Rankin Scale (mRS) score of 0-2 at 90 days
To evaluate the neurological recovery of subjects at 90 days after randomization. The modified Rankin Scale (mRS) will be used for assessment. The mRS score ranges from 0 to 6, where 0 indicates no symptoms, 1 indicates no significant disability, and 2 indicates slight disability but able to look after own affairs without assistance. This outcome measure defines an mRS score of 0-2 as a good functional outcome (functional independence), and the proportion of subjects achieving an mRS score of 0-2 will be calculated.
Time frame: 90 days (± 4 days) after randomization
Distribution of modified Rankin Scale (mRS) scores at 90 days after randomization
To evaluate the overall distribution of neurological disability in subjects at 90 days after randomization. The modified Rankin Scale (mRS) will be used, with scores ranging from 0 to 6. This outcome measure will summarize and report the number and proportion of subjects in each mRS score category (0, 1, 2, 3, 4, 5, 6).
Time frame: 90 days (± 4 days) after randomization
Plan to share: Yes
Supporting information: Study protocol, Statistical analysis plan, Analytic code
Time frame: Individual participant data (IPD) and supporting information will be available starting 6 months after publication and ending 5 years after publication.
Access criteria: De-identified IPD, the study protocol, and statistical analysis plan will be made available to researchers whose proposed use of the data is approved by an independent review committee. Data will be shared after signing a Data Use Agreement (DUA) and can be requested by contacting the corresponding author.
Started Mar 2026 (actual). Primary completion is estimated for Dec 2028, 33 months after the start.
Of 3,108 non-industry interventional studies with no phase under Stroke, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 46. This study's planned 33 months is above that.
Counting every sponsor, half of 3,252 studies reached it within 23 months; a quarter within 10 and three quarters within 46.
How these figures are worked out, and which studies are left out of them.
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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The First Affiliated Hospital of Bengbu Medical University