Timea Hodics, Leonardo G Cohen, John C Pezzullo, Karen Kowalske, Alexander W Dromerick
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引用次数: 1
Abstract
Background and purpose: Brain stimulation is an adjuvant strategy to promote rehabilitation after stroke. Here, we evaluated the influence of inclusion/exclusion criteria on enrollment in a transcranial direct current stimulation (tDCS) trial in the context of a racially/ethnically diverse acute stroke service at University of Texas Southwestern (UTSW).
Methods: 3124 (59.7 ± 14.5 years) racially/ethnically diverse (38.4% non-Hispanic white, (W), Hispanic (H) 22%, African American (AA) 33.5%, Asian (A) 2.3%) patients were screened in the acute stroke service at UTSW. Demographics, stroke characteristics, and reasons for exclusion were recorded prospectively.
Results: 2327 (74.5%) patients had a verified stroke. Only 44 of them (1.9%) were eligible. Causes for exclusion included in order of importance: (1) magnitude of upper extremity (UE) motor impairment, (2) prior strokes (s), (3) hemorrhagic stroke, (4) psychiatric condition or inability to follow instructions, and (5) old age, of these (2) and (4) were more common in AA patients but not in other minorities. 31 of the 44 eligible individuals were enrolled (W 1.68%, H 1.37%, AA .77%, A 3.774%). 90.5% of verified stroke patients did not exhibit contraindications for stimulation.
Conclusions: 3 main conclusions emerged: (a) The main limitations for inclusion in brain stimulation trials of motor recovery were magnitude of UE motor impairments and stroke lesion characteristics, (b) most stroke patients could be stimulated with tDCS without safety concerns and (c) carefully tailored inclusion criteria could increase diversity in enrollment.Clinical Trial Registration-URL: http://clinicaltrials.gov. Unique identifier: NCT01007136.
背景与目的:脑刺激是促进脑卒中后康复的辅助策略。在这里,我们评估了纳入/排除标准对入组经颅直流电刺激(tDCS)试验的影响,该试验是在德克萨斯大学西南分校(UTSW)不同种族/民族急性卒中服务的背景下进行的。方法:在UTSW的急性卒中服务中筛选了3124例(59.7±14.5岁)不同种族/民族的患者(38.4%非西班牙裔白人,(W),西班牙裔(H) 22%,非洲裔美国人(AA) 33.5%,亚洲人(A) 2.3%)。前瞻性地记录人口统计学、卒中特征和排除原因。结果:2327例(74.5%)患者发生卒中。其中只有44人(1.9%)符合条件。排除的原因按重要性顺序包括:(1)上肢运动损伤程度,(2)既往中风,(3)出血性中风,(4)精神状况或不能遵循指示,(5)年龄,这些(2)和(4)在AA患者中更常见,而在其他少数群体中则不常见。44个符合条件的个体中有31个入选(W 1.68%, H 1.37%, AA 0.77%, A 3.774%)。90.5%的确诊脑卒中患者没有出现刺激的禁忌症。结论:得出了3个主要结论:(a)纳入运动恢复脑刺激试验的主要限制是UE运动损伤的程度和脑卒中病变特征;(b)大多数脑卒中患者可以用tDCS进行刺激而不存在安全性问题;(c)精心定制的纳入标准可以增加入组的多样性。临床试验注册-网址:http://clinicaltrials.gov。唯一标识符:NCT01007136。
期刊介绍:
Neurorehabilitation & Neural Repair (NNR) offers innovative and reliable reports relevant to functional recovery from neural injury and long term neurologic care. The journal''s unique focus is evidence-based basic and clinical practice and research. NNR deals with the management and fundamental mechanisms of functional recovery from conditions such as stroke, multiple sclerosis, Alzheimer''s disease, brain and spinal cord injuries, and peripheral nerve injuries.