Cho Hee-Mun, Cha Seungwoo, Sohn Min Kyun, Jee Sungju, Chang Won Kee, Kim Won-Seok, Paik Nam-Jong
Department of Rehabilitation Medicine, Seoul National University College of Medicine, Seoul National University Bundang Hospital, Seongnam-si, Republic of Korea.
Department of Rehabilitation Medicine, Chungnam National University College of Medicine, Chungnam National University Hospital, Daejeon, Republic of Korea.
Front Neurol. 2023 Aug 25;14:1216510. doi: 10.3389/fneur.2023.1216510. eCollection 2023.
The incidence of stroke is increasing steadily due to factors such as population aging. Approximately 80% of stroke survivors have motor disorders affecting their daily lives. Repetitive transcranial magnetic stimulation (rTMS) has been reported to maximize functional recovery after stroke along with exercise intervention in upper limb rehabilitation treatment. However, whether rTMS affects the recovery of upper limb function in patients with stroke remains unclear. Therefore, in this trial, we will investigate the efficacy of low-frequency rTMS in patients with subcortical and brainstem ischemic stroke.
This study has been designed as a multi-center, double-blind, randomized controlled trial to compare the efficacy of low-frequency rTMS over the contralesional M1 with sham stimulation. Overall, 88 participants will be allocated to the intervention or control group in a 1:1 ratio, with stratification according to their initial upper extremity Fugl-Meyer assessment (UE-FMA) score. The participants will receive either 30 min of real rTMS (intervention group) or sham rTMS (control group), followed by 30 min of occupational therapy for 10 consecutive workdays. All the participants will receive the same amount of rehabilitation therapy throughout the intervention period. Evaluations will be performed at baseline (T0), at the end of treatment (T1), and 4 weeks after the end of treatment (T2), including the box and block test (BBT), UE-FMA, Korean version of the Modified Barthel Index, and NIH Stroke Scale scores, Finger tapping test, Brunnstrom stage, modified Ashworth scale, and grip strength. The primary outcome will be the change in the BBT score between T0 and T2.
This study will provide evidence on the efficacy of low-frequency rTMS in motor function recovery of the upper limb in patients with subacute, subcortical, and brainstem ischemic stroke.
ClinicalTrials.gov, identifier [NCT05535504].
由于人口老龄化等因素，中风的发病率正在稳步上升。约80%的中风幸存者存在影响其日常生活的运动障碍。据报道，在中风后的上肢康复治疗中，重复经颅磁刺激（rTMS）与运动干预相结合可最大程度地促进功能恢复。然而，rTMS是否会影响中风患者上肢功能的恢复仍不清楚。因此，在本试验中，我们将研究低频rTMS对皮质下和脑干缺血性中风患者的疗效。
本研究设计为一项多中心、双盲、随机对照试验，以比较低频rTMS与对侧M1区假刺激的疗效。总体而言，88名参与者将按1:1的比例分配至干预组或对照组，并根据其初始上肢Fugl-Meyer评估（UE-FMA）评分进行分层。参与者将接受30分钟的真实rTMS（干预组）或假rTMS（对照组），随后连续10个工作日每天接受30分钟的职业治疗。在整个干预期内，所有参与者将接受相同量的康复治疗。将在基线（T0）、治疗结束时（T1）以及治疗结束后4周（T2）进行评估，包括箱块测试（BBT）、UE-FMA、韩国版改良Barthel指数和美国国立卫生研究院卒中量表评分、手指敲击试验、Brunnstrom分期、改良Ashworth量表和握力。主要结局将是T0至T2期间BBT评分的变化。
本研究将为低频rTMS对亚急性、皮质下和脑干缺血性中风患者上肢运动功能恢复的疗效提供证据。
ClinicalTrials.gov，标识符[NCT05535504]
