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NOT YET RECRUITING
NCT07645586
PHASE3

A Phase 3 Trial of Lesion Network Mapping-Guided cTBS for Motor Recovery After Acute Ischemic Stroke

Sponsor: Beijing Tiantan Hospital

View on ClinicalTrials.gov

Summary

This Phase 3 study will evaluate whether lesion network mapping-guided continuous theta burst stimulation (cTBS) can improve recovery after acute ischemic stroke. The treatment uses each participant's brain imaging to identify individualized stimulation targets related to stroke symptoms. Participants will receive either active cTBS or a sham procedure in addition to standard stroke care. The study will assess whether this personalized brain stimulation approach improves functional recovery and is safe for patients after ischemic stroke.

Official title: Lesion Network Mapping-Navigated Continuous Theta-Burst Stimulation for Motor Recovery in Acute Ischemic Stroke: A Randomized, Double-Blind, Sham-Controlled, Multicentre Phase 3 Trial: MASTRE-3

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

584

Start Date

2026-06-15

Completion Date

2027-12-30

Last Updated

2026-06-12

Healthy Volunteers

No

Conditions

Interventions

DEVICE

LNM-navigated cTBS

Individualized treatment targets are defined by outlining each patient's acute infarct lesion on MRI and projecting it onto a normative functional connectivity map to identify symptom-relevant network nodes within sensorimotor regions. Treatment is delivered over seven consecutive days using a figure-8 coil guided by neuronavigation. cTBS consists of 3-pulse bursts at 50 Hz, repeated at 5 Hz, for a total of 600 pulses over 40 seconds, delivered at 80% of the resting motor threshold (RMT).

DEVICE

Sham cTBS

Sham stimulation follows the same MRI-based lesion mapping, target selection, neuronavigation workflow, coil positioning, timing, acoustic noise, and treatment course as the active group, but uses a sham figure-8 coil that mimics stimulation without generating a significant magnetic field. This design helps maintain blinding of participants and assessors while ensuring that no effective magnetic stimulation is delivered.

Locations (1)

Beijing Tiantan Hospital

Beijing, China