NCT05957354

pBFS-guided Dual-target cTBS for Aphasia After Stroke

Personalized Brain Functional Sector-guided Dual-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

The objective of this trial is to evaluate the effectiveness and safeness 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) 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 dual-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 combination of stimulation sequences, including a 600-pulse cTBS targeting at the right IFG, followed by a 600-pulse cTBS targeting at the right STG, which will be repeated once more (a total of 2400 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 combination 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, which will be repeated once more (a total of 2400 pulses daily). Each patient will receive a 3-week treatment period, consisting of 5 consecutive workdays each week.

Timeline

• Start date: 2023-07-28
• Primary completion: 2025-08-01
• Completion: 2025-12-01
• First posted: 2023-07-24
• Last updated: 2025-04-04

Locations

2 sites across 1 country: China