Different doses of intermittent theta burst stimulation for upper limb motor dysfunction after stroke: a study protocol for a randomized controlled trial

Zhiqing Tang; Tianhao Liu; Ying Liu; Kaiyue Han; Wenlong Su; Jingdu Zhao; Qianqian Chi; Xiaonian Zhang; Hao Zhang

doi:10.3389/fnins.2023.1259872

Different doses of intermittent theta burst stimulation for upper limb motor dysfunction after stroke: a study protocol for a randomized controlled trial

Front Neurosci. 2023 Oct 5:17:1259872. doi: 10.3389/fnins.2023.1259872. eCollection 2023.

Authors

Zhiqing Tang^{1

2}, Tianhao Liu^{1

2}, Ying Liu^{1

2}, Kaiyue Han^{1

2}, Wenlong Su^{1

2

3}, Jingdu Zhao^{1

2}, Qianqian Chi^{1

2}, Xiaonian Zhang^{1

2}, Hao Zhang^{1

2

3

4}

Affiliations

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

Abstract

Background: Upper limb motor recovery is one of the important goals of stroke rehabilitation. Intermittent theta burst stimulation (iTBS), a new type of repetitive transcranial magnetic stimulation (rTMS), is considered a potential therapy. However, there is still no consensus on the efficacy of iTBS for upper limb motor dysfunction after stroke. Stimulus dose may be an important factor affecting the efficacy of iTBS. Therefore, we aim to investigate and compare the effects and neural mechanisms of three doses of iTBS on upper limb motor recovery in stroke patients, and our hypothesis is that the higher the dose of iTBS, the greater the improvement in upper limb motor function.

Methods: This prospective, randomized, controlled trial will recruit 56 stroke patients with upper limb motor dysfunction. All participants will be randomized in a 1:1:1:1 ratio to receive 21 sessions of 600 pulses active iTBS, 1,200 pulses active iTBS, 1,800 pulses active iTBS, or 1,800 pulses sham iTBS in addition to conventional rehabilitation training. The primary outcome is the Fugl-Meyer Assessment of the Upper Extremity (FMA-UE) score from baseline to end of intervention, and the secondary outcomes are the Wolf Motor Function Test (WMFT), Grip Strength (GS), Modified Barthel Index (MBI), and Stroke Impact Scale (SIS). The FMA-UE, MBI, and SIS are assessed pre-treatment, post-treatment, and at the 3-weeks follow-up. The WMFT, GS, and resting-state functional magnetic resonance imaging (rs-fMRI) data will be obtained pre- and post-treatment.

Discussion: The iTBS intervention in this study protocol is expected to be a potential method to promote upper limb motor recovery after stroke, and the results may provide supportive evidence for the optimal dose of iTBS intervention.

Keywords: intermittent theta burst stimulation; randomized controlled trial; stroke; study protocol; upper limb.

Grants and funding

The author(s) declare financial support was received for the research, authorship, and/or publication of this article. This work was supported by the China Rehabilitation Research Center Youth fund project (No. 2023ZX-Q3).