Ischemic Stroke, AcuteNCT06639360
Effects of Transcranial Magnetic Stimulation After Endovascular Treatment for Acute Ischemic Stroke
A study testing Transcranial Magnetic Stimulation Active in people with Ischemic Stroke, Acute and Endovascular Thrombectomy, run by Xijing Hospital at 1 site in China.
Trial summary
This is a multicenter, randomized, double-blind, sham-controlled trial, to determine the efficacy and safety of cTBS in treating patients with acute ischemic stroke after endovascular treatment. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Ischemic Stroke, Acute, Endovascular Thrombectomy
- What is being tested?
- Transcranial Magnetic Stimulation Active
- 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
- 2 Aug 2025to 31 Dec 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with acute anterior circulation ischemic stroke aged between 18 and 80 years old.
- Imaging suggests that the infarction is caused by occlusion of the terminal portion of the internal carotid artery or the M1/M2 segment of the middle cerebral artery.
- A head CT within 24 hours of onset indicates an ASPECT score ≥6, and meets the guideline-recommended criteria for thrombectomy.
- Pre-stroke mRS score is ≤1.
- NIHSS score before thrombectomy is between 6 and 25.
- With vascular recanalization of mTICI > 2b/3.
- Informed consent form signed.
Who cannot join
- Patients with contraindications to TMS treatment, such as those with metallic foreign objects in the head, pacemakers, implantable drug pumps, cochlear implants, etc.;
- Patients with epilepsy, increased intracranial pressure, tumors, acute cerebral hemorrhage, or other severe neurological diseases, and those with severe functional impairment of organs such as the heart, liver, and kidneys;
- Head CT/MRI indicates midline shift or significant mass effect, or patients planned for surgical intervention;
- Head CT/MRI suggests acute cerebral infarction in both sides;
- Patients who are pregnant or breastfeeding;
- Patients with severe mental disorders or dementia who cannot cooperate with follow-up;
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- Patients with other severe diseases resulting in an expected survival of less than 90 days;
- Patients who are participating in other interventional clinical studies within 30 days before the start of this study or after the onset of this condition;
- Patients who cannot cooperate with informed consent.
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
Xijing Hospital
Xi'an, Shaanxi, 710032
Jingjing Zhao, MD, +8618192829590, zhaojing0110@126.com
About this study
This is a multicenter, randomized, double-blind, sham-controlled trial, to determine the efficacy and safety of cTBS in treating patients with acute ischemic stroke after endovascular treatment.
- Conditions
- Ischemic Stroke, Acute, Endovascular Thrombectomy
- Being tested
- Transcranial Magnetic Stimulation Active, Transcranial Magnetic Stimulation Sham
- 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 Magnetic Stimulation ActiveDevice
The patients will be treated with cTBS and usual medical treatment after endovascular treatment
Transcranial Magnetic Stimulation ShamDevice
The patients will be treated with sham-cTBS and usual medical treatment after endovascular treatment
| Study group | Role | What they receive |
|---|---|---|
| Active-cTBS group | Experimental | Patients assigned to the Active-cTBS group will be treated with cTBS and usual medical treatment after endovascular treatment Receives: Device: Transcranial Magnetic Stimulation Active |
| Sham-cTBS group | Sham comparator | Patients assigned to the Sham-cTBS group will be treated with sham-cTBS and usual medical treatment after endovascular treatment Receives: Device: Transcranial Magnetic Stimulation Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of infarct volumes from baseline to Day 5
Measured: 5 days after enrollment
Death
Measured: The first 5 days after enrollment
NIHSS at Day 5
Measured: 5 days after enrollment
Secondary outcomes (7)
Early neurological deterioration
proportion of patients with an increase of ≥4 points in NIHSS at 3 days
Measured: 3 days after enrollment
Final infarct volume
The infarct volume on DWI at 5 days
Measured: 5 days after enrollment
Intracranial hemorrhage incidence
Measured: 24h after enrollment
Proportion of patients with symptomatic intracranial hemorrhage
Measured: 90 days after enrollment
Proportion of patients with mRS 0-2
Measured: 90 days after enrollment
Barthel Index score
Measured: 90 days after enrollment
Stroke recurrence
Measured: 90 days after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start2 Aug 2025
- Primary completion30 Sep 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic Stroke, AcuteStudies of the same condition, open and under way.
- More trials run by Xijing HospitalThe sponsor's other registered studies.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06639360
- Sponsor's protocol ID
- KY20242288-C-1
- Status last verified
- Aug 2025
- First submitted
- 10 Oct 2024
- Last updated
- 4 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Transcranial Magnetic Stimulation After Endovascular Treatment for Acute Ischemic Stroke
- ClinicalTrials.gov ID
- NCT06639360
- Acronym / sponsor ID
- KY20242288-C-1
- Conditions
- Ischemic Stroke, Acute, Endovascular Thrombectomy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- 2 Aug 2025 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 15 Oct 2024 (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 is a multicenter, randomized, double-blind, sham-controlled trial, to determine the efficacy and safety of cTBS in treating patients with acute ischemic stroke after endovascular treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active-cTBS group | Experimental | Device: Transcranial Magnetic Stimulation ActivePatients assigned to the Active-cTBS group will be treated with cTBS and usual medical treatment after endovascular treatment |
| Sham-cTBS group | Sham comparator | Device: Transcranial Magnetic Stimulation ShamPatients assigned to the Sham-cTBS group will be treated with sham-cTBS and usual medical treatment after endovascular treatment |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients with acute anterior circulation ischemic stroke aged between 18 and 80 years old.
- Imaging suggests that the infarction is caused by occlusion of the terminal portion of the internal carotid artery or the M1/M2 segment of the middle cerebral artery.
- A head CT within 24 hours of onset indicates an ASPECT score ≥6, and meets the guideline-recommended criteria for thrombectomy.
- Pre-stroke mRS score is ≤1.
- NIHSS score before thrombectomy is between 6 and 25.
Key exclusion criteria (9 listed)
- Patients with contraindications to TMS treatment, such as those with metallic foreign objects in the head, pacemakers, implantable drug pumps, cochlear implants, etc.;
- Patients with epilepsy, increased intracranial pressure, tumors, acute cerebral hemorrhage, or other severe neurological diseases, and those with severe functional impairment of organs such as the heart, liver, and kidneys;
- Head CT/MRI indicates midline shift or significant mass effect, or patients planned for surgical intervention;
- Head CT/MRI suggests acute cerebral infarction in both sides;
- Patients who are pregnant or breastfeeding;
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 Magnetic Stimulation ActiveThe patients will be treated with cTBS and usual medical treatment after endovascular treatment | Device | Active-cTBS group |
| Transcranial Magnetic Stimulation ShamThe patients will be treated with sham-cTBS and usual medical treatment after endovascular treatment | Device | Sham-cTBS group |
Primary outcome
Changes of infarct volumes from baseline to Day 5
Time frame: 5 days after enrollment
Death
Time frame: The first 5 days after enrollment
NIHSS at Day 5
Time frame: 5 days after enrollment
7 secondary outcomes
Early neurological deterioration
Time frame: 3 days after enrollment
Final infarct volume
Time frame: 5 days after enrollment
Intracranial hemorrhage incidence
Time frame: 24h after enrollment
Proportion of patients with symptomatic intracranial hemorrhage
Time frame: 90 days after enrollment
Proportion of patients with mRS 0-2
Time frame: 90 days after enrollment
Barthel Index score
Time frame: 90 days after enrollment
Stroke recurrence
Time frame: 90 days after enrollment
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 4 Dec 2025.
- Individual participant dataSharing planned: No
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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 Transcranial Magnetic Stimulation Active in people with Ischemic Stroke, Acute and Endovascular Thrombectomy, run by Xijing Hospital 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 9 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 4 Dec 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 Jingjing Zhao, Dr. (+86-29-84775365, zhaojing0110@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of infarct volumes from baseline to Day 5 (time frame: 5 days after enrollment). The study lists 3 primary outcomes in all. 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 4 Dec 2025.