NCT06086938

pBFS-guided cTBS Combined With iTBS Over the Superior Frontal Gyrus for Aphasia After Ischemic Stroke

Personalized Brain Functional Sector-guided Continuous Theta Burst Stimulation Combined With Intermittent Theta Burst Stimulation Therapy Targeting at the Superior Frontal Gyrus for Aphasia After Ischemic Stroke: a RCT

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Changping Laboratory · Academic / Other
• Sex: All
• Age: 35 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The current study aims to evaluate the efficacy and safety of pBFS-guided cTBS combined with iTBS for the rehabilitation of language functions in patients with post-ischemic stroke aphasia.

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 double-blinded, randomized and parallel controlled design trial, to investigate the efficacy and safety of pBFS-guided personalized cTBS combined with iTBS intervention in post-stroke aphasic patients. Subjects will be randomly assigned to the following two groups: active TBS（cTBS+iTBS）group, or a sham TBS（sham cTBS+sham iTBS）group. The allocation ratio will be 1:1. The stimulation protocol consisted of a 3-week treatment, with five consecutive days each week (totally 15 day-treatment) .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 combined with iTBS	Daily TBS treatment consists of the following combination: active 600-pulse cTBS applied to the superior frontal gyrus (SFG) in the unaffected hemisphere + active 600-pulse iTBS applied to the SFG in the affected hemisphere + 15 minutes of rest + active 600-pulse cTBS applied to the SFG in the unaffected hemisphere + active 600-pulses iTBS applied to the SFG in the affected hemisphere, totaling 2400 pulses of TBS intervention. The intervention mentioned above will be administered once per day with five consecutive days per week, continuously for three weeks.
DEVICE	sham cTBS combined with iTBS	Daily sham TBS treatment consists of the following combination: sham 600-pulse cTBS applied to the superior frontal gyrus (SFG) in the unaffected hemisphere + sham 600-pulse iTBS applied to the SFG in the affected hemisphere + 15 minutes of rest + sham 600-pulse cTBS applied to the SFG in the unaffected hemisphere + 600-pulse sham iTBS applied to the SFG in the affected hemisphere, totaling 2400 pulses of sham TBS intervention. The intervention mentioned above will be administered once per day with five consecutive days per week, continuously for three weeks.

Timeline

• Start date: 2023-10-20
• Primary completion: 2024-10-20
• Completion: 2025-10-20
• First posted: 2023-10-17
• Last updated: 2023-10-23