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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Continuous Theta-burst Stimulation | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement of motor function | Fugl-Meyer motor function score (FMMS) change from baseline at 7 days. FMMS 0-100 (higher score indicates better) | 7 days |
| Serious adverse events ( SAEs ) | Serious adverse events ( SAEs ) | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 7 days |
| Improvement of motor function |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Tiantan Hospital | Beijing | Beijing Municipality | 100070 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37314250 | Background | 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. | |
| 41974577 | Derived | Ding 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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| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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To ensure the blind method, the sham stimulation coil will be used, which has the same parameters (including stimulation frequency, time, etc.) as the cTBS group, and has the same stimulation sound to ensure no effective stimulation, to ensure the blind state is maintained during the test. Investigators and patients who participate in the study treatment or are involved in the clinical evaluation of patients will be blinded to treatment grouping.
|
| Sham stimulation | Device | 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. |
|
Fugl-Meyer motor function score (FMMS) change from baseline at 90 days. FMMS 0-100 (higher score indicates better)
| 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) | 90 days |
| Funtional outcome | Proportion of patients with an mRS score of 0-2 at Day 90 (± 7 days) post-randomization. | 90 days |
| Barthel index of ADL | Barthel index of ADL, 0-100 (higher score indicates better) | 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." | 90 days |
| Symptomatic intracranial hemorrhage | Proportion of symptomatic intracranial hemorrhage (sICH) | 7 days |
| Symptomatic intracranial hemorrhage | Proportion of symptomatic intracranial hemorrhage (sICH) | 90 days |
| Mortality | Rate of death from any cause within 90 days | 90 days |
| Adverse events ( AEs ) | Rate of adverse events ( AEs ) within 90 days | 90 days |
| Stroke recurrence | Cerebral infarction, cerebral hemorrhage | 90 days |
| D009422 |
| Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |