BMJ Open. 2026 Jan 13;16(1):e102372. doi: 10.1136/bmjopen-2025-102372.
ABSTRACT
INTRODUCTION: Transcranial magnetic stimulation (TMS) and upper extremity manipulation training have demonstrated clinical effectiveness in stroke rehabilitation. Post-stroke, the affected cerebral cortex often shows reduced excitability, which can limit the optimal outcomes of conventional manual training. To address this, we developed a new upper limb training method integrating TMS with active sensory training (AST) to enhance the fine motor ability in the upper limbs following stroke, potentially improving overall rehabilitation efficacy. However, the clinical effectiveness of this approach remains unclear. Importantly, we demonstrated the efficacy of the new rehabilitation strategy by using TMS in conjunction with AST in patients experiencing upper limb motor dysfunction after stroke.
METHODS AND ANALYSIS: This single-centre, single-blind, sham stimulation, randomised controlled clinical trial investigated the efficacy of AST combined with TMS in patients with stroke and upper limb motor dysfunction post-stroke (1-24 months post-onset) at Brunnstrom stages III-V. Upper limb motor function was evaluated before and 2 weeks after the intervention. The primary outcome was the Action Research Arm Test result, and the secondary indicators included results on the Fugl-Meyer Assessment Upper Extremity Scale, Modified Barthel Index, Semmes-Weinstein Monofilament, Erasmus MC revised Nottingham Sensory Assessment Scale, Embodied Sense of Self Scale (stroke version), functional near-infrared spectroscopy and neuroelectrophysiology. Between-group differences were analysed using independent t-tests, and within-group differences were examined with paired t-tests, with statistical significance set at p<0.05.
ETHICS AND DISSEMINATION: This study was approved by the Ethics Committee of the Second Rehabilitation Hospital of Shanghai for ethical application (Approval number: 2024-34-01). Written informed consent will be obtained from all participants. Study results will be disseminated through peer-reviewed journals and presentations at local and international conferences.
TRIAL REGISTRATION NUMBER: ChiCTR2500097067.
PMID:41529889 | DOI:10.1136/bmjopen-2025-102372