Beijing Tiantan Hospital
Beijing, Beijing Municipality, 100070, China
NCT Number: NCT06400407
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.
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Notify Me18 year–80 year
All sexes
Interventional
Phase 2
Beijing, Beijing Municipality, 100070, China
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Time frame: 7 days
Fugl-Meyer motor function score (FMMS) change from baseline at 7 days. FMMS 0-100 (higher score indicates better)
Time frame: 7 days
Serious adverse events ( SAEs )
Time frame: 7 days
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)
Time frame: 90 days
Fugl-Meyer motor function score (FMMS) change from baseline at 90 days. FMMS 0-100 (higher score indicates better)
Time frame: 90 days
Proportion of patients with an mRS score of 0-1 at Day 90 (± 7 days) post-randomization. mRS 0-6 (lower score indicates better)
Time frame: 90 days
Proportion of patients with an mRS score of 0-2 at Day 90 (± 7 days) post-randomization.
Time frame: 90 days
Barthel index of ADL, 0-100 (higher score indicates better)
Time frame: 90 days
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."
Time frame: 7 days
Proportion of symptomatic intracranial hemorrhage (sICH)
Time frame: 90 days
Proportion of symptomatic intracranial hemorrhage (sICH)
Time frame: 90 days
Rate of death from any cause within 90 days
Time frame: 90 days
Rate of adverse events ( AEs ) within 90 days
Time frame: 90 days
Cerebral infarction, cerebral hemorrhage
Beijing Tiantan Hospital
Other
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
Acronym: MASTRE
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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