Brain stimulation and constraint for perinatal stroke hemiparesis The PLASTIC CHAMPS Trial
Brain stimulation and constraint for perinatal stroke hemiparesis The PLASTIC CHAMPS Trial
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DOI：
10.1212/wnl.0000000000002646
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发表时间：
2016-05-03
期刊：
影响因子：
9.9
通讯作者：
Hill, Michael D.
中科院分区：
文献类型：
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作者：
Kirton, Adam;Andersen, John;Hill, Michael D.
目的：确定在强化治疗中加入重复经颅磁刺激（rTMS）和/或强制性诱导运动疗法（CIMT）是否能增加围产期卒中和轻偏瘫儿童的运动功能。方法：设盲析因设计，随机对照试验（clinicaltrials.gov/NCT01189058）评估了rTMS和CIMT对MRI证实的围产期卒中偏瘫儿童（6-19岁）的影响。所有人都完成了为期2周的，目标导向的，同伴支持的运动学习营，随机分为每日rTMS，CIMT，两者兼而有之，或两者都不。主要结果是辅助手评估和加拿大职业表现测量在基线，1周，2和6个月后干预。结果评估者对治疗不知情。在12和24名参与者后进行中期安全性分析。意向治疗分析检查治疗效果随着时间的推移（线性混合效应模型）。增加rTMS、CIMT或两者都增加了临床显著改善的机会。6个月时辅助手评估增益是加性的，rTMS 1 CIMT的增益最大（β系数5 5.54 [2.57-8.51]，p = 0.0004）。单独的营地产生了很大的改善，在加拿大职业表现测量分数，最大的6个月（科恩d = 1.6，p = 0.002）。生活质量评分改善。干预措施的耐受性良好，安全，没有减少任何一只手的功能。结论：偏瘫儿童参加密集的，心理社会康复计划可以实现持续的功能收益。证据分类：本研究提供了II类证据，结合rTMS和CIMT增强治疗引起的功能性运动增益脑卒中引起的偏瘫型脑瘫儿童。
Objective: To determine whether the addition of repetitive transcranial magnetic stimulation (rTMS) and/or constraint-induced movement therapy (CIMT) to intensive therapy increases motor function in children with perinatal stroke and hemiparesis.Methods: A factorial-design, blinded, randomized controlled trial (clinicaltrials.gov/NCT01189058) assessed rTMS and CIMT effects in hemiparetic children (aged 6-19 years) with MRI-confirmed perinatal stroke. All completed a 2-week, goal-directed, peer-supported motor learning camp randomized to daily rTMS, CIMT, both, or neither. Primary outcomes were the Assisting Hand Assessment and the Canadian Occupational Performance Measure at baseline, and 1 week, 2 and 6 months postintervention. Outcome assessors were blinded to treatment. Interim safety analyses occurred after 12 and 24 participants. Intention-to-treat analysis examined treatment effects over time (linear mixed effects model).Results: All 45 participants completed the trial. Addition of rTMS, CIMT, or both doubled the chances of clinically significant improvement. Assisting Hand Assessment gains at 6 months were additive and largest with rTMS 1 CIMT (beta coefficient 5 5.54 [2.57-8.51], p = 0.0004). The camp alone produced large improvements in Canadian Occupational Performance Measure scores, maximal at 6 months (Cohen d = 1.6, p = 0.002). Quality-of-life scores improved. Interventions were well tolerated and safe with no decrease in function of either hand.Conclusions: Hemiparetic children participating in intensive, psychosocial rehabilitation programs can achieve sustained functional gains. Addition of CIMT and rTMS increases the chances of improvement.Classification of evidence: This study provides Class II evidence that combined rTMS and CIMT enhance therapy-induced functional motor gains in children with stroke-induced hemiparetic cerebral palsy.