Effects of repetitive transcranial magnetic stimulation on upper extremity motor function in stroke survivors: study protocol of a randomized sham-controlled trial.

BACKGROUND

Stroke is a group of diseases with neurological deficits caused by cerebrovascular lesions. Despite standard treatment, a large number of patients are left with significant upper extremity motor dysfunction. Therefore, improving upper limb motor function and promoting neurological recovery in stroke patients has become a core challenge in the field of neurorehabilitation.

METHODS AND ANALYSIS: This study will be designed as a randomized, sham controlled clinical trial. Thirty-six patients with upper limb motor dysfunction after stroke will be included, and their Fugl-Meyer Upper Extremity Motor Function Rating Scale (FMA-UE) score will be ≤ 26 points. Subjects will be randomly assigned to the following three groups (n = 12/group): HF-rTMS: Treated with high-frequency (5 Hz) repetitive transcranial magnetic stimulation (rTMS) on the dorsal premotor cortex (PMd) on the contralesional side. Low-frequency group (LF-rTMS): Treated with low-frequency (1 Hz) rTMS on the primary motor cortex (M1) on the contralesional side. Sham control group: The stimulation target and parameter settings will be the same as those of the high-frequency group, but the coil will be placed perpendicular to the scalp plane. The intervention regimen will be rTMS treatment once daily, five times a week for 3 weeks. Outcome measures: Main outcome measures: Upper limb motor function, assessed by FMA-UE. Secondary outcomes: Barthel Index (BI), National Institutes of Health Stroke Scale (NIHSS). Exploratory indicators: fMRI data and motor evoked potential (MEP) parameters. All assessment data will be collected before and after the intervention.

COMMUNICATION AND ETHICS: This study has been reviewed and approved by the Basic and Clinical Research Ethics Committee of Sichuan Provincial People's Hospital (Lun Shen (Yan) No. 353-1 of 2025). The results of this research will be disseminated through the network of professionals and the general public, and peer-reviewed scientific papers will be published and presented at relevant conferences.

REGISTRATION: This trial has been registered with the Chinese Clinical Trials Registry with registration number ChiCTR2500105502.