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 at 3-14 days after 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
60
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.
Beijing Tiantan Hospital
Beijing, Beijing Municipality, China
Improvement of motor function
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 )
Serious adverse events ( SAEs )
Time frame: 7 days
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)
Time frame: 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)
Time frame: 90 days
Excellent functional outcome
Proportion of excellent functional outcome defined as an modified Rankin Scale (mRS) score ≤ 1 at 90 days. mRS 0-6 (lower score indicates better)
Time frame: 90 days
Barthel index of ADL
Barthel index of ADL, 0-100 (higher score indicates better)
Time frame: 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."
Time frame: 90 days
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Symptomatic intracranial hemorrhage
Proportion of symptomatic intracranial hemorrhage (sICH)
Time frame: 7 days
Symptomatic intracranial hemorrhage
Proportion of symptomatic intracranial hemorrhage (sICH)
Time frame: 90 days
Mortality
Rate of death from any cause within 90 days
Time frame: 90 days
Adverse events ( AEs )
Rate of adverse events ( AEs ) within 90 days
Time frame: 90 days
Stroke recurrence
Cerebral infarction, cerebral hemorrhage
Time frame: 90 days