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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The objective of this trial is to evaluate the effectiveness and safeness of continuous Theta Burst Stimulation (cTBS) over the right Inferior Frontal Gyrus (IFG), guided by personalized Brain Functional Sector (pBFS) technology, on language function recovery in patients with post-ischemic stroke aphasia.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 35
Maximum Age: 75
Healthy Volunteers: f
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• Patients between the ages of 35 and 75 years (including 35 and 75 years).

• Meet the diagnostic criteria of acute ischemic stroke (using the 2019 American Heart Association/American Stroke Association Guidelines for the Early Management of Patients With Acute Ischemic Stroke: 2019 Update to the 2018 Guidelines for the Early Management of Acute Ischemic Stroke and the 2018 Chinese Society of Neurology Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke in China). All lesions should be in the left hemisphere, and the course of disease should be more than or equal to 15 days and less than or equal to 3 months .

• Meet the diagnostic criteria for aphasia according to the Chinese version of the Western Aphasia Battery (WAB), with a WAB-aphasia quotient less than 93.8.

• First onset stroke.

• Normal functioning language abilities before the stroke, with Mandarin as their native language and an educational level higher than primary school (more than 6 years' education).

• Understand the trial and be able to provide informed consent.

Locations
Other Locations
China
First Affiliated Hospital of Fujian Medical University
RECRUITING
Fuzhou
Contact Information
Primary
Jianting Huang, MD,PhD
jianting.huang@pku.edu.cn
010-80726688
Backup
Ruiqi Pan
ruiqipanedu@163.com
010-80726688
Time Frame
Start Date: 2023-08-23
Estimated Completion Date: 2025-12-30
Participants
Target number of participants: 30
Treatments
Active_comparator: active cTBS group
active cTBS combined with speech language therapy
Sham_comparator: sham cTBS group
sham cTBS combined with speech language therapy
Related Therapeutic Areas
Sponsors
Leads: Changping Laboratory
Collaborators: First Affiliated Hospital of Fujian Medical University

This content was sourced from clinicaltrials.gov