Gharooni Aref-Ali, Nair Krishnan Padmakumari Sivaraman, Hawkins Debby, Scivill Ian, Hind Daniel, Hariharan Ram
Princess Royal Spinal Injuries Centre, Sheffield Teaching Hospitals, Sheffield, UK.
Clinical Trials Research Unit, University of Sheffield, Regent Court, 30 Regent Court, Sheffield, S1 4DA, UK.
Spinal Cord. 2018 Aug;56(8):762-768. doi: 10.1038/s41393-018-0152-5. Epub 2018 Jun 12.
Single-blind, sham-controlled, crossover randomized feasibility study OBJECTIVES: (1) Assess the feasibility of a full-scale trial of intermittent theta-burst stimulation (iTBS) for upper-limb sensorimotor dysfunction following spinal cord injury (SCI). (2) Determine the safety and tolerability of iTBS over primary motor cortex on upper-limb function in people with spinal cord injury (SCI).
Large Tertiary Spinal Injuries Centre METHODS: Participants with incomplete SCI, suffering with upper-limb spasticity were recruited and randomized to receive active/sham iTBS over the hand representation of the primary motor cortex. The intervention was delivered in 10 sessions over a 2-week period, followed by a 2-week washout, before being crossed over to receive the alternative intervention for the same number of sessions. Feasibility was assessed by pre-specified criteria which included recruitment rate of 3 participants per month, 10 completed interventions and 10 complete data sets for 15 recruited participants with no serious adverse events. Secondary outcomes included preliminary data collection for spasticity, pain and sensorimotor function.
Twelve participants were recruited over 10 weeks (i.e., 4.8 per month), with 11 randomized and 10 completing the intervention protocol with no serious adverse events. Eight complete data sets were obtained as two participants failed to attend follow-up. Data from 10 participants were analyzed, with one early dropout due to an unrelated adverse event.
It is safe and feasible to conduct a full-scale trial. Whilst iTBS has shown promising results, further research optimizing the intervention is required to improve anticipated clinical efficacy.
单盲、假刺激对照、交叉随机可行性研究
（1）评估对脊髓损伤（SCI）后上肢感觉运动功能障碍进行间歇性theta波爆发刺激（iTBS）全面试验的可行性。（2）确定对脊髓损伤（SCI）患者的初级运动皮层进行iTBS对上肢功能的安全性和耐受性。
大型三级脊髓损伤中心
招募患有上肢痉挛的不完全性SCI参与者，并随机分配接受对初级运动皮层手部代表区的主动/假iTBS。干预在2周内进行10次，随后有2周的洗脱期，然后交叉接受相同次数的替代干预。通过预先指定的标准评估可行性，这些标准包括每月招募3名参与者、10次完成的干预以及为15名招募的参与者获取10套完整数据集且无严重不良事件。次要结果包括收集关于痉挛、疼痛和感觉运动功能的初步数据。
在10周内招募了12名参与者（即每月4.8名），11名被随机分组，10名完成了干预方案且无严重不良事件。由于两名参与者未参加随访，获得了8套完整数据集。分析了10名参与者的数据，其中一名因无关不良事件提前退出。
进行全面试验是安全可行的。虽然iTBS已显示出有前景的结果，但需要进一步研究优化干预措施以提高预期的临床疗效。
