NCT05929534

pBFS-guided iTBS Over the Superior Temporal Gyrus for Aphasia After Ischemic Stroke

Personalized Brain Functional Sector-guided Intermittent Theta Burst Stimulation Therapy Targeting at the Superior Temporal 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 objective of this trial is to evaluate the effectiveness and safeness of intermittent Theta Burst Stimulation (iTBS) over the left Superior Temporal Gyrus (STG), guided by personalized Brain Functional Sector (pBFS) technology, on language function recovery 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 Sector (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 sham controlled trial, to investigate the efficacy and safety of pBFS-guided personalized rTMS intervention in post-stroke aphasic patients. Subjects will be randomly assigned to the following two groups: active intermittent TBS (iTBS) group, or a sham control group. The allocation ratio will be 1:1. The stimulation protocol consists 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 intermittent Theta Burst Stimulation	Each patient will receive two 600-pulse iTBS stimulations per day, parted by a 15-minute rest period (a total of 1200 pulses daily), for 3-week treatment, with five consecutive days each week.
DEVICE	sham intermittent Theta Burst Stimulation	Each patient will receive two sham 600-pulse iTBS stimulations per day, parted by a 15-minute rest period (a total of 1200 pulses daily), for 3-week treatment, with five consecutive days each week.

Timeline

• Start date: 2023-07-01
• Primary completion: 2024-06-30
• Completion: 2025-06-30
• First posted: 2023-07-03
• Last updated: 2023-07-10