Acute Ichemic StrokeNCT07912450
Study on the Efficacy and Safety of Non-Invasive Brain-Computer Interface With MRI-Guided Multi-Channel Time-Domain Interference Stimulation in Treating Motor Dysfunction in Acute Cerebral Infarction Patients
A study testing Transcranial Temporal Interference Stimulation (tTIS) in people with Acute Ichemic Stroke, run by The First Affiliated Hospital of Bengbu Medical University at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Ichemic 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
- 378 participants
- Where
- 1 siteChina
- Study dates
- 24 Mar 2026to Dec 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
- Acute ischemic stroke confirmed by CT or MRI;
- Age 18 to 80 years;
- Time from symptom onset ≤ 72 hours;
- Baseline NIHSS score 4-24, and pre-stroke mRS score 0-2;
- Motor dysfunction score of unilateral upper and lower limbs ≥ 4.
Who cannot join
- 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 contraceptive measures during the trial.
- -
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
First Affiliated Hospital of Bengbu Medical University
Bengbu, Anhui, 233000
About this study
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.
Read more
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:
- Primary outcome: 90-day mRS score 0-2;
- Secondary outcomes: 90-day mRS score distribution; 90-day mRS 0-1 or recovery to pre-stroke disability status (if pre-stroke mRS > 1); NIHSS score 10 days after treatment.
Read the detailed description
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:
- Primary outcome: 90-day mRS score 0-2;
- Secondary outcomes: 90-day mRS score distribution; 90-day mRS 0-1 or recovery to pre-stroke disability status (if pre-stroke mRS > 1); NIHSS score 10 days after treatment.
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).
- Conditions
- Acute Ichemic Stroke
- Being tested
- Transcranial Temporal Interference Stimulation (tTIS), Sham tTIS
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
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.
Sham tTISDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Active Stimulation Group | Experimental | 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. Receives: Device: Transcranial Temporal Interference Stimulation (tTIS) |
| Sham Stimulation Group | Sham comparator | 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. Receives: Device: Sham tTIS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 90 days (± 4 days) after randomization
Secondary outcomes (1)
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).
Measured: 90 days (± 4 days) after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2026
- Study start24 Mar 2026
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Ichemic StrokeStudies of the same condition, open and under way.
- 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 378 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of Bengbu Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07912450
- Sponsor's protocol ID
- [2026] KY003
- Other IDs
- [2026] KY003
- Status last verified
- Oct 2026
- First submitted
- 28 Oct 2026
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Mirzakhalili E, Barra B, Capogrosso M, Lempka SF. Biophysics of Temporal Interference Stimulation. Cell Syst. 2020 Dec 16;11(6):557-572.e5. doi: 10.1016/j.cels.2020.10.004. Epub 2020 Nov 5.
PubMed 33157010
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Efficacy and Safety of Non-Invasive Brain-Computer Interface With MRI-Guided Multi-Channel Time-Domain Interference Stimulation in Treating Motor Dysfunction in Acute Cerebral Infarction Patients
- ClinicalTrials.gov ID
- NCT07912450
- Acronym / sponsor ID
- [2026] KY003
- Conditions
- Acute Ichemic Stroke
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 378 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Bengbu Medical UniversityUniversity, hospital or other
- Study start
- 24 Mar 2026 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 3 Nov 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.
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:
- Primary outcome: 90-day mRS score 0-2;
- Secondary outcomes: 90-day mRS score distribution; 90-day mRS 0-1 or recovery to pre-stroke disability status (if pre-stroke mRS > 1); NIHSS score 10 days after treatment.
Detailed description
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:
- Primary outcome: 90-day mRS score 0-2;
- Secondary outcomes: 90-day mRS score distribution; 90-day mRS 0-1 or recovery to pre-stroke disability status (if pre-stroke mRS > 1); NIHSS score 10 days after treatment.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Stimulation Group | Experimental | Device: Transcranial Temporal Interference Stimulation (tTIS)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. |
| Sham Stimulation Group | Sham comparator | Device: Sham tTISParticipants 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Acute ischemic stroke confirmed by CT or MRI;
- Age 18 to 80 years;
- Time from symptom onset ≤ 72 hours;
- Baseline NIHSS score 4-24, and pre-stroke mRS score 0-2;
- Motor dysfunction score of unilateral upper and lower limbs ≥ 4.
Key exclusion criteria (2 listed)
- 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 contraceptive measures during the trial.
- -
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 |
|---|---|---|
| Transcranial Temporal Interference Stimulation (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. | Device | Active Stimulation Group |
| Sham tTISParticipants 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 Stimulation Group |
Primary outcome
Proportion of subjects with modified Rankin Scale (mRS) score of 0-2 at 90 days
Time frame: 90 days (± 4 days) after randomization
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.
1 secondary outcome
Distribution of modified Rankin Scale (mRS) scores at 90 days after randomization
Time frame: 90 days (± 4 days) after randomization
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 3 Nov 2026.
- Background: PubMed 33157010Mirzakhalili E, Barra B, Capogrosso M, Lempka SF. Biophysics of Temporal Interference Stimulation. Cell Syst. 2020 Dec 16;11(6):557-572.e5. doi: 10.1016/j.cels.2020.10.004. Epub 2020 Nov 5.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial Temporal Interference Stimulation (tTIS) in people with Acute Ichemic Stroke, run by The First Affiliated Hospital of Bengbu Medical University 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 5 inclusion and 2 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: enrolling by invitation, as of the sponsor's last update on 3 Nov 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of subjects with modified Rankin Scale (mRS) score of 0-2 at 90 days (time frame: 90 days (± 4 days) after randomization). 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 NCT07912450, which also lists 1 linked publication.
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 3 Nov 2026.