Trials · 2026
Effects of rTMS combined with rPMS on complete postoperative median nerve injury: study protocol for a randomized control study.
СтатьяПротокол клинического исследованияНазвание и аннотация: Перевод в очереди
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Chen Xianggui, Lin Jiali, Chen Zihang, Zhang Yongli, He Zhijie, Deng Panmo, Chen Shugeng, Jia Jie
Аннотация
BACKGROUND: Peripheral nerve injuries (PNI) commonly result in multiple dysfunctions in clinical practice. Repetitive peripheral magnetic stimulation (rPMS) and repetitive transcranial magnetic stimulation (rTMS) are non-invasive interventions for neuromodulation. Their benefits have been reported respectively in PNI rehabilitation, but little is known about their combined effect. Combined central-peripheral interventions were found to have better improvements than central- or peripheral-only intervention in numerous studies. Hence, we conducted a randomized controlled trial to assess the effect of rPMS combined with rTMS on postoperative median nerve injury (PMNI) and explore its mechanism.
METHODS: In this prospective, single-center, randomized clinical trial, we will enroll 60 participants with PMNI and randomize them into four groups (conventional intervention group, rPMS + sham rTMS group, sham rPMS + rTMS group, and rPMS + rTMS group) at a 1:1:1:1 ratio. All participants will undergo interventions for 12 weeks and be assessed at 0, 6, and 12 weeks during the treatment. Measurements will include grip strength, side pinch, Semmes-Weinstein monofilament test (SW), two-point discrimination test (2PD), Purdue pegboard test (PPT), motor conduction velocity test (MCV), and sensory conduction velocity test (SCV). Moreover, functional near-infrared spectroscopy (fNIRS) will be used to explore brain mechanisms. Statistical analysis will be performed using SPSS software with the significance level set at p < 0.05.
DISCUSSION: The results of this study will develop innovative magnetic stimulation techniques for the rehabilitation of PMNI.
TRIAL REGISTRATION: This study prospective protocol was approved by the Medical Ethics Committee of Shanghai Jing'an District Central Hospital (ethical approval number 202437, study protocol version 1.0). The trial was prospectively registered at the Chinese Clinical Trial Registry on December 16, 2024, with the name "Effects of Repetitive Transcranial Magnetic Stimulation Combined with Repetitive Peripheral Magnetic Stimulation on Complete Postoperative Median Nerve Injury: Protocol of A Randomized Control Study" (registration number ChiCTR2400094038).
METHODS: In this prospective, single-center, randomized clinical trial, we will enroll 60 participants with PMNI and randomize them into four groups (conventional intervention group, rPMS + sham rTMS group, sham rPMS + rTMS group, and rPMS + rTMS group) at a 1:1:1:1 ratio. All participants will undergo interventions for 12 weeks and be assessed at 0, 6, and 12 weeks during the treatment. Measurements will include grip strength, side pinch, Semmes-Weinstein monofilament test (SW), two-point discrimination test (2PD), Purdue pegboard test (PPT), motor conduction velocity test (MCV), and sensory conduction velocity test (SCV). Moreover, functional near-infrared spectroscopy (fNIRS) will be used to explore brain mechanisms. Statistical analysis will be performed using SPSS software with the significance level set at p < 0.05.
DISCUSSION: The results of this study will develop innovative magnetic stimulation techniques for the rehabilitation of PMNI.
TRIAL REGISTRATION: This study prospective protocol was approved by the Medical Ethics Committee of Shanghai Jing'an District Central Hospital (ethical approval number 202437, study protocol version 1.0). The trial was prospectively registered at the Chinese Clinical Trial Registry on December 16, 2024, with the name "Effects of Repetitive Transcranial Magnetic Stimulation Combined with Repetitive Peripheral Magnetic Stimulation on Complete Postoperative Median Nerve Injury: Protocol of A Randomized Control Study" (registration number ChiCTR2400094038).