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首页> 外文期刊>Trials >Effects of high-frequency transcranial magnetic stimulation on functional performance in individuals with incomplete spinal cord injury: study protocol for a randomized controlled trial
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Effects of high-frequency transcranial magnetic stimulation on functional performance in individuals with incomplete spinal cord injury: study protocol for a randomized controlled trial

机译：高频经颅磁刺激对不完全脊髓损伤患者功能性能的影响：一项随机对照试验的研究方案

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Repetitive transcranial magnetic stimulation (rTMS) has been investigated as a new tool in neurological rehabilitation of individuals with spinal cord injury (SCI). However, due to the inconsistent results regarding the effects of rTMS in people with SCI, a randomized controlled double-blind crossover trial is needed to clarify the clinical utility and to assess the effect size of rTMS intervention in this population. Therefore, this paper describes a study protocol designed to investigate whether the use of rTMS can improve the motor and sensory function, as well as reduce spasticity in patients with incomplete SCI. A double-blind randomized sham-controlled crossover trial will be performed by enrolling 20 individuals with incomplete SCI. Patients who are at least six months post incomplete SCI (aged 18–60 years) will be recruited through referral by medical practitioners or therapists. Individuals will be randomly assigned to either group 1 or group 2 in a 1:1 ratio, with ten individuals in each group. The rTMS protocol will include ten sessions of high-frequency rTMS (5?Hz) over the bilateral lower-limb motor area positioned at the vertex (Cz). Clinical evaluations will be performed at baseline and after rTMS active and sham. rTMS has produced positive results in treating individuals with physical impairments; thus, it might be promising in the SCI population. The results of this study may provide new insights to motor rehabilitation thereby contributing towards the better usage of rTMS in the SCI population. ClinicalTrials.gov, NCT02899637 . Registered on 25 August 2016.
机译：反复经颅磁刺激（rTMS）已被研究为脊髓损伤（SCI）患者神经康复的一种新工具。但是，由于关于rTMS在SCI患者中作用的结果不一致，因此需要一项随机对照双盲交叉试验来阐明其临床效用并评估rTMS干预对该人群的影响大小。因此，本文描述了一项旨在研究使用rTMS是否可以改善SCI不完全患者的运动和感觉功能以及减少痉挛的研究方案。通过招募20名不完整SCI的个体来进行双盲随机假对照交叉试验。 SCI不完整后至少六个月（18-60岁）的患者将通过医生或治疗师的转诊招募。将以1：1的比例将个体随机分配到第1组或第2组，每组十个人。 rTMS协议将在位于顶点（Cz）的双侧下肢运动区域上包括十次高频rTMS（5？Hz）。临床评估将在基线，rTMS活跃和假手术后进行。 rTMS在治疗身体有障碍的人方面取得了积极的成果;因此，在SCI人群中可能很有希望。这项研究的结果可能为运动康复提供新的见解，从而有助于在SCI人群中更好地使用rTMS。 ClinicalTrials.gov，NCT02899637。 2016年8月25日注册。

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