NCT05842304

Individualized Precision rTMS for Language Recovery in Patients After Ischemic Stroke: a Multi-center RCT

Personalized Brain Functional Sectors (pBFS)-Guided rTMS Intervention for Aphasia After Ischemic Stroke: a Multi-center, Randomized, Parallel Controlled Study

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 180 (estimated)
• Sponsor: Changping Laboratory · Academic / Other
• Sex: All
• Age: 35 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The current multi-center study aims to evaluate the efficacy and safety of pBFS-guided rTMS Neuromodulation Treatment for the rehabilitation of language functions in ischemic stroke aphasic patients.

Detailed description

Increasing evidence suggests that rTMS has been effective in treating various psychological and neurological diseases, including treating post-stroke symptoms. Using the personalized brain functional sectors (pBFS) technique, we could precisely identify individualized brain functional networks and the personalized language-related stimulation site based on the resting-state functional MRI data. The current study proposes to conduct a multi-center, double-blinded, randomized and parallel controlled design trial, to investigate the efficacy and safety of pBFS-guided personalized TMS intervention in post-stroke aphasic patients. Subjects will be randomly assigned to the following two groups: active continuous TBS (cTBS) group, or a sham control group. The allocation ratio will be 2:1. Subjects will receive a 3-week treatment for 21 consecutive days. The stimulation procedure will be assisted with real-time neuronavigation to ensure its precision.

Conditions

• Stroke, Ischemic
• Aphasia

Interventions

Type	Name	Description
DEVICE	active cTBS	Each patient will receive three 600-pulse cTBS stimulations per day, parted by two 15-minute rest periods (a total of 1800 pulses daily), for 21 consecutive days (3 weeks).
DEVICE	sham cTBS	Each patient will receive three 600-pulse sham cTBS stimulations per day, parted by two 15-minute rest periods (a total of 1800 pulses daily), for 21 consecutive days (3 weeks).

Timeline

• Start date: 2023-06-05
• Primary completion: 2025-05-10
• Completion: 2026-05-10
• First posted: 2023-05-06
• Last updated: 2024-06-20

Locations

1 site across 1 country: China