NCT06400407

Lesion Network MApping Navigated Continuous Theta-burst STimulation for Motor REcovery in Acute Ischemic Stroke

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Beijing Tiantan Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Stroke, Acute Ischemic

Interventions

Type	Name	Description
DEVICE	Continuous Theta-burst Stimulation	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.
DEVICE	Sham stimulation	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.

Timeline

• Start date: 2024-10-21
• Primary completion: 2025-10-27
• Completion: 2026-01-12
• First posted: 2024-05-06
• Last updated: 2026-04-08

Locations

1 site across 1 country: China