Stroke, Acute IschemicPhase 2MASTRENCT06400407
Lesion Network MApping Navigated Continuous Theta-burst STimulation for Motor REcovery in Acute Ischemic Stroke
A Phase 2 study testing Continuous Theta-burst Stimulation in people with Stroke, Acute Ischemic, run by Beijing Tiantan Hospital at 1 site in China.
Trial summary
This is a multicenter, sham-controlled, double-blind, randomized clinical trial to evaluate the efficacy and safety of lesion network mapping navigated cTBS in improving motor function in patients with acute ischemic stroke within 14 days of symptom onset. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stroke, Acute Ischemic
- What is being tested?
- Continuous Theta-burst Stimulation
- 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
- 21 Oct 2024to 12 Jan 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Age 18-80 years old.
- Acute ischemic stroke confirmed by CT or MRI at 14 days after onset.
- Pre-stroke modified Rankin scale (mRS) score≤1.
- 4≤NIHSS score≤ 25, 1a≤1, NIHSS5a/5b/6a/6b≥2 at least.
- Moderate or severe motor dysfunction (Fugl-Meyer motor score < 80).
- Written informed consent from patients or their legally authorized representatives.
Who cannot join
- TMS contraindications include metallic foreign bodies in the head, pacemaker, implantable drug pumps, cochlear implants, etc.
- Epilepsy or history of epilepsy, intracranial hypertension, tumor and other serious neurological disorders;
- Midline displacement and brain parenchymal mass effect seen in head CT and other images;
- Head CT or MRI showed bilateral acute cerebral infarction;
- Evidence of acute intracranial hemorrhage;
- A history of congenital or acquired hemorrhagic disease, coagulation factor deficiency, or thrombocytopenia disease;
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- After blood pressure control, the systolic blood pressure was still ≥180 mmHg or the diastolic blood pressure was ≥110 mmHg;
- Patients during pregnancy or lactation and within 90 days of planned pregnancy;
- Patients with severe mental disorders or dementia who can not cooperate with informed consent and follow-up;
- Patients with malignancy or severe systemic disease and expected survival of less than 90 days;
- Participants in other clinical intervention studies within 30 days before randomization or who were participating in other clinical intervention studies.
- Patients with ataxia (NIHSS 7 ≥ 1) and aphasia (NIHSS 9 ≥ 2).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Lesion Network Mapping Navigated Continuous Theta-burst Stimulation for Motor Recovery in Acute Ischemic Stroke:A Randomized, Double-Blind, Sham-Controlled, Phase 2 Pilot Trial
This is a multicenter, sham-controlled, double-blind, randomized clinical trial to evaluate the efficacy and safety of lesion network mapping navigated cTBS in improving motor function in patients with acute ischemic stroke within 14 days of symptom onset.
Read the detailed description
The target population of this study was patients with acute ischemic stroke. Lesion network mapping and navigation were used to select individual stimulation targets. Enrolled patients were randomly assigned in a 1:1 ratio to the "cTBS group" or the "Sham stimulation group" and received:
cTBS group: Based on the map, an 8-shaped coil was used to stimulate the motor function-related targets. The stimulation intensity was RMT80%, 600 pulses, 50Hz, 40s per target, and the stimulation interval was more than 2 hours. The total course of treatment lasted 7 days.
Sham stimulation group: A Sham stimulation coil was used to stimulate based on the map. The sound and duration were the same as the cTBS group, ensuring no effective stimulation. The total course of treatment lasted 7 days.
- Conditions
- Stroke, Acute Ischemic
- Being tested
- Continuous Theta-burst Stimulation, Sham stimulation
- Keywords
- Continuous Theta-burst Stimulation, Acute ischemic stroke, Motor recovery, Lesion network mapping, Navigation
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous Theta-burst StimulationDevice
Based on the map, an 8-shaped coil was used to stimulate the motor function-related targets. The stimulation intensity was RMT80%, 600 pulses, 50Hz, 40s per target, and the stimulation interval was more than 2 hours. The total course of treatment lasted 7 days.
Sham stimulationDevice
A Sham stimulation coil was used to stimulate based on the map. The sound and duration were the same as the cTBS group, ensuring no effective stimulation. The total course of treatment lasted 7 days.
| Study group | Role | What they receive |
|---|---|---|
| Continuous Theta-burst Stimulation | Experimental | Based on the map, an 8-shaped coil was used to stimulate the motor function-related targets. The stimulation intensity was RMT80%, 600 pulses, 50Hz, 40s per target, and the stimulation interval was more than 2 hours. The treatment course lasted for 7 days. Receives: Device: Continuous Theta-burst Stimulation |
| Sham stimulation | Sham comparator | A Sham stimulation coil was used to stimulate based on the map. The sound and duration were the same as the cTBS group, ensuring no effective stimulation. The treatment course lasted for 7 days. Receives: Device: Sham stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of motor function
Fugl-Meyer motor function score (FMMS) change from baseline at 7 days. FMMS 0-100 (higher score indicates better)
Measured: 7 days
Serious adverse events ( SAEs )
Serious adverse events ( SAEs )
Measured: 7 days
Secondary outcomes (11)
Early neurological improvement (ENI)
The proportion of patients with a reduction of ≥4 on the NIHSS, compared with the baseline score or an NIHSS of 0 or 1. NIHSS 0-42 (lower score indicates better)
Measured: 7 days
Improvement of motor function
Fugl-Meyer motor function score (FMMS) change from baseline at 90 days. FMMS 0-100 (higher score indicates better)
Measured: 90 days
Excellent functional outcome
Proportion of patients with an mRS score of 0-1 at Day 90 (± 7 days) post-randomization. mRS 0-6 (lower score indicates better)
Measured: 90 days
Funtional outcome
Proportion of patients with an mRS score of 0-2 at Day 90 (± 7 days) post-randomization.
Measured: 90 days
Barthel index of ADL
Barthel index of ADL, 0-100 (higher score indicates better)
Measured: 90 days
EQ-5D-5L
he Health Questionnaire (EQ-5D-5L) is a self-report survey that measures quality of life across 5 domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is scored on a 5-level severity ranking that ranges from "no problems" through "extreme problems."
Measured: 90 days
Symptomatic intracranial hemorrhage
Proportion of symptomatic intracranial hemorrhage (sICH)
Measured: 7 days
Symptomatic intracranial hemorrhage
Proportion of symptomatic intracranial hemorrhage (sICH)
Measured: 90 days
Mortality
Rate of death from any cause within 90 days
Measured: 90 days
Adverse events ( AEs )
Rate of adverse events ( AEs ) within 90 days
Measured: 90 days
Stroke recurrence
Cerebral infarction, cerebral hemorrhage
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2024
- Study start21 Oct 2024
- Primary completion27 Oct 2025
- Study completion12 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Stroke, Acute IschemicStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yongjun Wang, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06400407
- Sponsor's protocol ID
- HX-C-2024001
- Acronym
- MASTRE
- Status last verified
- Apr 2026
- First submitted
- 1 May 2024
- Last updated
- 8 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ding L, Liu H, Jing J, Jiang Y, Meng X, Chen Y, Zhao X, Niu H, Liu T, Wang Y, Li Z. Lesion Network Mapping for Neurological Deficit in Acute Ischemic Stroke. Ann Neurol. 2023 Sep;94(3):572-584. doi: 10.1002/ana.26721. Epub 2023 Jun 27.
PubMed 37314250Ding L, Liu H, Liu W, Yi L, Zhou Y, Zang Y, Jing J, Gong X, Jia Q, Wang Y, Liu T, Li Z. Lesion network mapping navigated continuous theta burst stimulation for motor recovery in acute ischaemic stroke (MASTRE): rationale and design of a randomised double-blind controlled multicentre phase 2 trial. Stroke Vasc Neurol. 2026 Apr 13:svn-2025-004641. doi: 10.1136/svn-2025-004641. Online ahead of print.
PubMed 41974577
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lesion Network Mapping Navigated Continuous Theta-burst Stimulation for Motor Recovery in Acute Ischemic Stroke:A Randomized, Double-Blind, Sham-Controlled, Phase 2 Pilot Trial
- ClinicalTrials.gov ID
- NCT06400407
- Acronym / sponsor ID
- MASTRE / HX-C-2024001
- Conditions
- Stroke, Acute Ischemic
- Keywords
- Continuous Theta-burst Stimulation, Acute ischemic stroke, Motor recovery, Lesion network mapping, Navigation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Study start
- 21 Oct 2024 (actual)
- Primary completion
- 27 Oct 2025 (actual)
- Study completion
- 12 Jan 2026 (actual)
- First posted
- 6 May 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, sham-controlled, double-blind, randomized clinical trial to evaluate the efficacy and safety of lesion network mapping navigated cTBS in improving motor function in patients with acute ischemic stroke within 14 days of symptom onset.
Detailed description
The target population of this study was patients with acute ischemic stroke. Lesion network mapping and navigation were used to select individual stimulation targets. Enrolled patients were randomly assigned in a 1:1 ratio to the "cTBS group" or the "Sham stimulation group" and received:
cTBS group: Based on the map, an 8-shaped coil was used to stimulate the motor function-related targets. The stimulation intensity was RMT80%, 600 pulses, 50Hz, 40s per target, and the stimulation interval was more than 2 hours. The total course of treatment lasted 7 days.
Sham stimulation group: A Sham stimulation coil was used to stimulate based on the map. The sound and duration were the same as the cTBS group, ensuring no effective stimulation. The total course of treatment lasted 7 days.
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 |
|---|---|---|
| Continuous Theta-burst Stimulation | Experimental | Device: Continuous Theta-burst StimulationBased on the map, an 8-shaped coil was used to stimulate the motor function-related targets. The stimulation intensity was RMT80%, 600 pulses, 50Hz, 40s per target, and the stimulation interval was more than 2 hours. The treatment course lasted for 7 days. |
| Sham stimulation | Sham comparator | Device: Sham stimulationA Sham stimulation coil was used to stimulate based on the map. The sound and duration were the same as the cTBS group, ensuring no effective stimulation. The treatment course lasted for 7 days. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 18-80 years old.
- Acute ischemic stroke confirmed by CT or MRI at 14 days after onset.
- Pre-stroke modified Rankin scale (mRS) score≤1.
- 4≤NIHSS score≤ 25, 1a≤1, NIHSS5a/5b/6a/6b≥2 at least.
- Moderate or severe motor dysfunction (Fugl-Meyer motor score < 80).
Key exclusion criteria (12 listed)
- TMS contraindications include metallic foreign bodies in the head, pacemaker, implantable drug pumps, cochlear implants, etc.
- Epilepsy or history of epilepsy, intracranial hypertension, tumor and other serious neurological disorders;
- Midline displacement and brain parenchymal mass effect seen in head CT and other images;
- Head CT or MRI showed bilateral acute cerebral infarction;
- Evidence of acute intracranial hemorrhage;
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 |
|---|---|---|
| Continuous Theta-burst StimulationBased on the map, an 8-shaped coil was used to stimulate the motor function-related targets. The stimulation intensity was RMT80%, 600 pulses, 50Hz, 40s per target, and the stimulation interval was more than 2 hours. The total course of treatment lasted 7 days. | Device | Continuous Theta-burst Stimulation |
| Sham stimulationA Sham stimulation coil was used to stimulate based on the map. The sound and duration were the same as the cTBS group, ensuring no effective stimulation. The total course of treatment lasted 7 days. | Device | Sham stimulation |
Primary outcome
Improvement of motor function
Time frame: 7 days
Fugl-Meyer motor function score (FMMS) change from baseline at 7 days. FMMS 0-100 (higher score indicates better)
Serious adverse events ( SAEs )
Time frame: 7 days
Serious adverse events ( SAEs )
11 secondary outcomes
Early neurological improvement (ENI)
Time frame: 7 days
Improvement of motor function
Time frame: 90 days
Excellent functional outcome
Time frame: 90 days
Funtional outcome
Time frame: 90 days
Barthel index of ADL
Time frame: 90 days
EQ-5D-5L
Time frame: 90 days
Symptomatic intracranial hemorrhage
Time frame: 7 days
Symptomatic intracranial hemorrhage
Time frame: 90 days
Mortality
Time frame: 90 days
Adverse events ( AEs )
Time frame: 90 days
Stroke recurrence
Time frame: 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2026.
- Background: PubMed 37314250Ding L, Liu H, Jing J, Jiang Y, Meng X, Chen Y, Zhao X, Niu H, Liu T, Wang Y, Li Z. Lesion Network Mapping for Neurological Deficit in Acute Ischemic Stroke. Ann Neurol. 2023 Sep;94(3):572-584. doi: 10.1002/ana.26721. Epub 2023 Jun 27.
- Derived from this study: PubMed 41974577Ding L, Liu H, Liu W, Yi L, Zhou Y, Zang Y, Jing J, Gong X, Jia Q, Wang Y, Liu T, Li Z. Lesion network mapping navigated continuous theta burst stimulation for motor recovery in acute ischaemic stroke (MASTRE): rationale and design of a randomised double-blind controlled multicentre phase 2 trial. Stroke Vasc Neurol. 2026 Apr 13:svn-2025-004641. doi: 10.1136/svn-2025-004641. Online ahead of print.
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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. This study is not recruiting at the moment.
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 Phase 2 study testing Continuous Theta-burst Stimulation in people with Stroke, Acute Ischemic, run by Beijing Tiantan 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 6 inclusion and 12 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: finished, as of the sponsor's last update on 8 Apr 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Improvement of motor function (time frame: 7 days). The study lists 2 primary outcomes in all. 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 NCT06400407, which also lists 2 linked publications.
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 8 Apr 2026.