NCT05957445

pBFS-guided Multi-target cTBS for Aphasia After Stroke

Personalized Brain Functional Sector-guided Multi-target Continuous Theta Burst Stimulation Therapy for Aphasia After Stroke: a RCT

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Changping Laboratory · Academic / Other
• Sex: All
• Age: 35 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

In this study, a randomized, double-blind, parallel-controlled trial was employed to evaluate the effectiveness and safety of personalized brain functional sectors (pBFS) technology-guided continuous theta burst stimulation (cTBS) on the inferior frontal gyrus (IFG) combined with the superior temporal gyrus (STG) and the superior frontal gyrus (SFG) for language function recovery in post-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, investigators 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 double-blinded, randomized and parallel controlled design trial, to investigate the efficacy and safety of pBFS-guided multi-target rTMS 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 1:1. The stimulation protocol consisted of a 3-week treatment, with 5 consecutive workdays each week (totally 15 day-treatment). The stimulation procedure will be assisted with real-time neuronavigation to ensure its precision.

Conditions

• Stroke
• Aphasia

Interventions

Type	Name	Description
DEVICE	active continuous Theta Burst Stimulation	Each patient will receive a series of stimulation sequences, including a 600-pulse cTBS targeting at the right IFG, followed by a 600-pulse cTBS targeting at the right STG, and subsequently a 600-pulse cTBS targeting at the right SFG. This sequence will be repeated once more (a total of 3600 pulses daily). Each patient will receive a 3-week treatment period, consisting of 5 consecutive workdays each week.
DEVICE	sham continuous Theta Burst Stimulation	Each patient will receive a series of stimulation sequences，including a 600-pulse sham cTBS targeting at the right IFG, followed by a 600-pulse sham cTBS targeting at the right STG, and subsequently a 600-pulse sham cTBS targeting at the right SFG. This sequence will be repeated once more (a total of 3600 pulses daily). Each patient will receive a 3-week treatment period, consisting of 5 consecutive workdays each week.

Timeline

• Start date: 2023-08-23
• Primary completion: 2025-06-01
• Completion: 2025-10-01
• First posted: 2023-07-24
• Last updated: 2025-04-04

Locations

3 sites across 1 country: China