Ischemic StrokeNCT06941961
iTBS for Acute Ischemic Stroke After Thrombectomy
A study testing intermittent theta burst stimulation in people with Ischemic Stroke, run by Yi Yang at 1 site in China.
Trial summary
The goal of this randomized, single-blind, parallel-controlled clinical trial is to evaluate the efficacy and safety of intermittent theta burst stimulation (iTBS) as an adjunctive therapy for acute anterior circulation ischemic stroke patients who have undergone successful mechanical thrombectomy (MT). Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Ischemic Stroke
- What is being tested?
- intermittent theta burst stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 178 participants
- Where
- 1 siteChina
- Study dates
- 25 Apr 2025to 1 Aug 2026
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1) Age 18-85 years, regardless of gender.
- 2) Acute ischemic stroke caused by occlusion of the anterior circulation large vessels (internal carotid artery, M1 or M2 segment of the middle cerebral artery), verified by CTA or DSA.
- 3) Mechanical thrombectomy (MT) performed within 24 hours of symptom onset.
- 4) Successful Reperfusion: Post-MT eTICI score ≥ 2b.
- 5) NIHSS score 5-25 at 24 hours post-MT, with ≥2 points in at least one limb.
Who cannot join
- 1) Pre-stroke modified Rankin Scale (mRS) score ≥2.
- 2) PH2-type intracranial hemorrhage on brain CT post-MT.
- 3) Patients who underwent intracranial stent placement during MT.
- 4) Contraindications to iTBS: History of epilepsy or seizures, implanted cardiac pacemakers, cochlear implants, or other electronic/magnetic-sensitive devices.
- 5) Severe consciousness impairment, cognitive dysfunction, or psychiatric disorders preventing compliance with iTBS.
- 6) Expected survival <3 months due to other medical conditions or inability to complete follow-up for any reason.
- 7) Participation in another interventional study.
- 8) Any other condition deemed unsuitable for enrollment by the investigator.
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
The First Hospital of Jilin University
Changchun, Jilin, 130000
Yi Yang, MD, PhD, 0086-13756661217, doctor_yangyi@163.com
About this study
Official title: Efficacy and Safety of Intermittent Theta Burst Stimulation in Acute Anterior Circulation Ischemic Stroke Patients Undergoing Mechanical Thrombectomy
The goal of this randomized, single-blind, parallel-controlled clinical trial is to evaluate the efficacy and safety of intermittent theta burst stimulation (iTBS) as an adjunctive therapy for acute anterior circulation ischemic stroke patients who have undergone successful mechanical thrombectomy (MT). The study population includes adults aged 18-85 with NIHSS scores 5-25 post-MT and eTICI≥2b reperfusion.
- Conditions
- Ischemic Stroke
- Being tested
- intermittent theta burst stimulation, sham intermittent theta burst stimulation
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intermittent theta burst stimulationDevice
The iTBS delivered to the ipsilesional primary motor cortex (M1) at 80% resting motor threshold (RMT). Each session consists of 600 pulses (3-minute trains of 50 Hz triplets repeated every 10 seconds, twice daily with a 5-minute interval), administered for 7 consecutive days starting within 6 hours post-randomization.
sham intermittent theta burst stimulationDevice
Sham-iTBS is performed in the same way as the treatment group but uses 20% RMT.
| Study group | Role | What they receive |
|---|---|---|
| iTBS | Active comparator | Patients are treated with intermittent theta burst stimulation (iTBS). Receives: Device: intermittent theta burst stimulation |
| sham-iTBS | Sham comparator | Patients are treated with sham intermittent theta burst stimulation (sham-iTBS). Receives: Device: sham intermittent theta burst stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with Modified Rankin Scale (mRS) Score 0-2 at 90 days
Modified Rankin Scale (mRS) ranged from 0 to 6, a low value represents a better outcome.
Measured: 90 days
Secondary outcomes (8)
Distribution of Modified Rankin Scale (mRS) Scores at 90 Days
mRS scores (0-6) assess functional independence, where lower scores indicate better outcomes.
Measured: 90 days
Distribution of Modified Rankin Scale (mRS) Scores at 30 Days
mRS scores (0-6) assess functional independence, where lower scores indicate better outcomes.
Measured: 30 days
Differences in National Institutes of Health Stroke Scale (NIHSS) Score at 7 days
NIHSS (0-42) measures neurological deficit severity, with lower scores indicating better function.
Measured: 7 days
Proportion of Patients with Early Neurological Deterioration (END) Within 7 Days
END is defined as an increase in NIHSS score ≥4 points from baseline.
Measured: 7 days
All-Cause Mortality Rate at 90 Days
Proportion of patients who died from any cause within 90 days.
Measured: From randomization to 90 days
Incidence of Intracranial Hemorrhage (ICH) and Symptomatic ICH (sICH) During Intervention
ICH is assessed via imaging
Measured: 7 days
Rate of iTBS-Related Adverse Events
Includes seizures, headache, scalp discomfort, or other stimulation-related AEs.
Measured: From randomization to 90 days
Overall Adverse Event (AE) Rate
Proportion of patients experiencing any AE during the study.
Measured: From randomization to 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2025
- Study start25 Apr 2025
- Primary completion1 Jul 2026 (estimated)
- Study completion1 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 178 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yi Yang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yi Yang, The First Hospital of Jilin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06941961
- Sponsor's protocol ID
- iTBS-ACT
- Status last verified
- Apr 2025
- First submitted
- 15 Apr 2025
- Last updated
- 30 Apr 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Intermittent Theta Burst Stimulation in Acute Anterior Circulation Ischemic Stroke Patients Undergoing Mechanical Thrombectomy
- ClinicalTrials.gov ID
- NCT06941961
- Acronym / sponsor ID
- iTBS-ACT
- Conditions
- Ischemic Stroke
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 178 participants (estimated)
- Lead sponsor
- Yi YangUniversity, hospital or other
- Study start
- 25 Apr 2025 (actual)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 1 Aug 2026 (estimated)
- First posted
- 24 Apr 2025 (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.
The goal of this randomized, single-blind, parallel-controlled clinical trial is to evaluate the efficacy and safety of intermittent theta burst stimulation (iTBS) as an adjunctive therapy for acute anterior circulation ischemic stroke patients who have undergone successful mechanical thrombectomy (MT). The study population includes adults aged 18-85 with NIHSS scores 5-25 post-MT and eTICI≥2b reperfusion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| iTBS | Active comparator | Device: intermittent theta burst stimulationPatients are treated with intermittent theta burst stimulation (iTBS). |
| sham-iTBS | Sham comparator | Device: sham intermittent theta burst stimulationPatients are treated with sham intermittent theta burst stimulation (sham-iTBS). |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 1) Age 18-85 years, regardless of gender.
- 2) Acute ischemic stroke caused by occlusion of the anterior circulation large vessels (internal carotid artery, M1 or M2 segment of the middle cerebral artery), verified by CTA or DSA.
- 3) Mechanical thrombectomy (MT) performed within 24 hours of symptom onset.
- 4) Successful Reperfusion: Post-MT eTICI score ≥ 2b.
- 5) NIHSS score 5-25 at 24 hours post-MT, with ≥2 points in at least one limb.
Key exclusion criteria (8 listed)
- 1) Pre-stroke modified Rankin Scale (mRS) score ≥2.
- 2) PH2-type intracranial hemorrhage on brain CT post-MT.
- 3) Patients who underwent intracranial stent placement during MT.
- 4) Contraindications to iTBS: History of epilepsy or seizures, implanted cardiac pacemakers, cochlear implants, or other electronic/magnetic-sensitive devices.
- 5) Severe consciousness impairment, cognitive dysfunction, or psychiatric disorders preventing compliance with iTBS.
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 |
|---|---|---|
| intermittent theta burst stimulationThe iTBS delivered to the ipsilesional primary motor cortex (M1) at 80% resting motor threshold (RMT). Each session consists of 600 pulses (3-minute trains of 50 Hz triplets repeated every 10 seconds, twice daily with a 5-minute interval), administered for 7 consecutive days starting within 6 hours post-randomization. | Device | iTBS |
| sham intermittent theta burst stimulationSham-iTBS is performed in the same way as the treatment group but uses 20% RMT. | Device | sham-iTBS |
Primary outcome
Proportion of patients with Modified Rankin Scale (mRS) Score 0-2 at 90 days
Time frame: 90 days
Modified Rankin Scale (mRS) ranged from 0 to 6, a low value represents a better outcome.
8 secondary outcomes
Distribution of Modified Rankin Scale (mRS) Scores at 90 Days
Time frame: 90 days
Distribution of Modified Rankin Scale (mRS) Scores at 30 Days
Time frame: 30 days
Differences in National Institutes of Health Stroke Scale (NIHSS) Score at 7 days
Time frame: 7 days
Proportion of Patients with Early Neurological Deterioration (END) Within 7 Days
Time frame: 7 days
All-Cause Mortality Rate at 90 Days
Time frame: From randomization to 90 days
Incidence of Intracranial Hemorrhage (ICH) and Symptomatic ICH (sICH) During Intervention
Time frame: 7 days
Rate of iTBS-Related Adverse Events
Time frame: From randomization to 90 days
Overall Adverse Event (AE) Rate
Time frame: From randomization to 90 days
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 30 Apr 2025.
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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 intermittent theta burst stimulation in people with Ischemic Stroke, run by Yi Yang 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 8 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 30 Apr 2025. 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 Yi Yang, MD, PhD (0086-13756661217, doctor_yangyi@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with Modified Rankin Scale (mRS) Score 0-2 at 90 days (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Apr 2025.