Patel Deeksha, Banerjee Rohit, Farooque Kamran, Gupta Deepak, Garg Bhavuk, Kumar Nand, Kochhar Kanwal Preet, Jain Suman
Department of Physiology, All India Institute of Medical Sciences, New Delhi, Delhi, India.
Department of Orthopedics, All India Institute of Medical Sciences, New Delhi, Delhi, India.
JMIR Res Protoc. 2025 Jun 27;14:e66531. doi: 10.2196/66531.
BACKGROUND: Intermittent theta burst stimulation (iTBS) is a noninvasive stimulation technique to induce neuronal and synaptic plasticity. The induced cortical plasticity is imperative in the recovery of motor and sensory functions. Spinal cord injury (SCI) causes damage to neurons and results in sensorimotor dysfunction. The effect of iTBS on recovery of motor and sensory dysfunction in complete SCI (cSCI) is still elusive. OBJECTIVE: This study aims to assess the effect of iTBS on corticospinal tract integrity, plasticity, and regaining of motor and sensory function in patients with cSCI. The rationale behind using an iTBS protocol is to modify and augment the communication between spared neurons of the corticospinal tract and strengthen the synaptic transmission, which will improve motor function in underlying muscles. METHODS: A total of 40 patients with cSCI with American Spinal Injury Association (ASIA) grade A, aged 18-60 years, were randomly assigned to 5 groups. To evaluate the efficacy of iTBS versus traditional repetitive transcranial magnetic stimulation, patients were categorized into placebo, repetitive transcranial magnetic stimulation, and iTBS. In addition, to determine the optimal site for stimulation, groups were further subdivided into motor cortex, spinal cord, and combined. Each patient underwent 10 iTBS sessions twice daily for 5 consecutive days. Neurological outcomes and functional outcome parameters will be assessed. Electrophysiological evaluations included transcranial magnetic stimulation single-pulse and paired-pulse parameters. The effect of iTBS intervention on biomarkers will be quantified using the enzyme-linked immunosorbent assay, while neurotransmitters will be quantified by liquid chromatography and tandem mass spectrometry. Measurements will be done before and after the intervention, with follow-ups at 1, 2, and 3 months. RESULTS: The outcome of the study will be defined by electrophysiological parameters elicited by single- and paired-pulse stimulation, ASIA score, pain, activities of daily life, quality of life, anxiety, depression, and biomarkers related to SCI. The results of this study will uncover the effectiveness of iTBS stimulation on (1) recovery of motor and sensory function in cSCI, (2) excitability of the corticospinal tract, (3) neurological recovery and modulation of pain, and (4) cortical reorganization after injury. CONCLUSIONS: iTBS in conjunction with an individualized rehabilitation program may serve as an integrated strategy to rejuvenate locomotor abilities and improve the overall quality of life for people with cSCI. TRIAL REGISTRATION: Clinical Trials Registry- India CTRI/2022/11/047038; https://ctri.nic.in/Clinicaltrials/main1.php?EncHid=13361.98443. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/66531.
背景:间歇性theta波爆发刺激(iTBS)是一种诱导神经元和突触可塑性的非侵入性刺激技术。诱导的皮质可塑性对于运动和感觉功能的恢复至关重要。脊髓损伤(SCI)会导致神经元损伤并导致感觉运动功能障碍。iTBS对完全性脊髓损伤(cSCI)患者运动和感觉功能障碍恢复的影响仍不明确。 目的:本研究旨在评估iTBS对cSCI患者皮质脊髓束完整性、可塑性以及运动和感觉功能恢复的影响。使用iTBS方案的基本原理是改变和增强皮质脊髓束备用神经元之间的通信,并加强突触传递,这将改善其下方肌肉的运动功能。 方法:总共40例年龄在18 - 60岁、美国脊髓损伤协会(ASIA)分级为A级的cSCI患者被随机分为5组。为了评估iTBS与传统重复经颅磁刺激的疗效,患者被分为安慰剂组、重复经颅磁刺激组和iTBS组。此外,为了确定最佳刺激部位,这些组进一步细分为运动皮层组、脊髓组和联合组。每位患者连续5天每天接受2次,每次10节iTBS治疗。将评估神经学结果和功能结果参数。电生理评估包括经颅磁刺激单脉冲和双脉冲参数。iTBS干预对生物标志物的影响将使用酶联免疫吸附测定进行量化,而神经递质将通过液相色谱和串联质谱进行量化。测量将在干预前后进行,并在1、2和3个月时进行随访。 结果:该研究的结果将由单脉冲和双脉冲刺激引发的电生理参数、ASIA评分、疼痛、日常生活活动、生活质量、焦虑、抑郁以及与SCI相关的生物标志物来定义。本研究的结果将揭示iTBS刺激对(1)cSCI患者运动和感觉功能恢复、(2)皮质脊髓束兴奋性、(3)神经恢复和疼痛调节以及(4)损伤后皮质重组的有效性。 结论:iTBS与个性化康复计划相结合可能作为一种综合策略,以恢复cSCI患者的运动能力并改善其整体生活质量。 试验注册:印度临床试验注册中心CTRI/2022/11/047038;https://ctri.nic.in/Clinicaltrials/main1.php?EncHid=13361.98443。 国际注册报告识别码(IRRID):DERR1-10.2196/66531。
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