Prolonged intermittent theta burst stimulation for post-stroke aphasia: protocol of a randomized, double-blinded, sham-controlled trial

Ying Liu; Jingdu Zhao; Zhiqing Tang; Yikuang Hsien; Kaiyue Han; Lei Shan; Xiaonian Zhang; Hao Zhang

doi:10.3389/fneur.2024.1348862

Prolonged intermittent theta burst stimulation for post-stroke aphasia: protocol of a randomized, double-blinded, sham-controlled trial

Front Neurol. 2024 Apr 25:15:1348862. doi: 10.3389/fneur.2024.1348862. eCollection 2024.

Authors

Ying Liu^{1

2}, Jingdu Zhao^{1

2}, Zhiqing Tang^{1

2}, Yikuang Hsien^{1

2}, Kaiyue Han^{1

2}, Lei Shan^{1

2}, Xiaonian Zhang^{1

2}, Hao Zhang^{1

2

3

4}

Affiliations

¹ School of Rehabilitation, Capital Medical University, Beijing, China.
² Beijing Bo'ai Hospital, China Rehabilitation Research Center, Beijing, China.
³ Cheeloo College of Medicine, Shandong University, Jinan, Shandong, China.
⁴ School of Life and Health Sciences, University of Health and Rehabilitation Sciences, Qingdao, China.

Abstract

Background: Post-stroke aphasia (PSA) is one of the most devastating symptoms after stroke, yet limited treatment options are available. Prolonged intermittent theta burst stimulation (piTBS) is a promising therapy for PSA. However, its efficacy remains unclear. Therefore, we aim to investigate the efficacy of piTBS over the left supplementary motor area (SMA) in improving language function for PSA patients and further explore the mechanism of language recovery.

Methods: This is a randomized, double-blinded, sham-controlled trial. A total of 30 PSA patients will be randomly allocated to receive either piTBS stimulation or sham stimulation for 15 sessions over a period of 3 weeks. The primary outcome is the Western Aphasia Battery Revised (WAB-R) changes after treatment. The secondary outcomes include The Stroke and Aphasia Quality of Life Scale (SAQOL-39 g), resting-state electroencephalogram (resting-state EEG), Event-related potentials (ERP), brain derived neurotrophic factor (BDNF). These outcome measures are assessed before treatment, after treatment, and at 4-weeks follow up. This study was registered in Chinese Clinical Trial Registry (No. ChiCTR23000203238).

Discussion: This study protocol is promising for improving language in PSA patients. Resting-state EEG, ERP, and blood examination can be used to explore the neural mechanisms of PSA treatment with piTBS.

Clinical trial registration: https://www.chictr.org.cn/index.html, ChiCTR2300074533.

Keywords: brain-derived neurotrophic factor; event-related potentials; post-stroke aphasia; prolonged intermittent theta burst stimulation; study protocol; supplementary motor area.

Grants and funding

The author(s) declare financial support was received for the research, authorship, and/or publication of this article. The authors acknowledge receiving financial support for the study. Funding for this work was provided by the General Project of the China Rehabilitation Research Center (2023ZX-15).