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

作者：Lingling Ding, Huan Liu, Wei Liu, Luo Yi, Yijun Zhou, Yingzhuo Zang, Jing Jing, Xiping Gong, Qian Jia, Yongjun Wang, Tao Liu, Zixiao Li · 发表于：Stroke and Vascular Neurology · 年份：2026 · DOI：10.1136/svn-2025-004641 · 研究领域：EEG and Brain-Computer Interfaces、Transcranial Magnetic Stimulation Studies、Stroke Rehabilitation and Recovery

BACKGROUND: In stroke recovery, the heterogeneity of lesions and symptoms makes it challenging to target neuromodulation precisely. Conventional one-size-fits-all neuromodulation approaches yield inconsistent outcomes, highlighting the need for precision strategies, such as lesion network mapping (LNM), to identify patient-specific symptom-related networks. AIM: To evaluate the efficacy and safety of LNM-guided continuous theta-burst stimulation (cTBS) in improving motor recovery in patients with acute ischaemic stroke (AIS) treated within 14 days of symptom onset. DESIGN: The mapping navigated continuous theta-burst stimulation for motor recovery (MASTRE) trial is a multicentre, randomised, double-blind, sham-controlled Phase 2 study. Eligible participants will be randomly assigned (1:1) to receive either active LNM-guided cTBS or sham stimulation. For each participant, individualised stimulation targets will be determined through LNM, and real-time neuronavigation will be used to ensure precise modulation of the disrupted sensorimotor network. Treatment will consist of one daily session for seven consecutive days. In each session, cTBS will be delivered as bursts of three pulses at 50 Hz, repeated every 200 ms for 40 s. STUDY OUTCOMES: The primary efficacy outcome is the change in Fugl-Meyer Assessment total motor score from baseline to Day 7 post-randomisation. Safety assessments will include symptomatic intracranial haemorrhage and adverse events, which will be monitored ...