Department of Neurology and Neurotherapeutics, 12334University of Texas Southwestern Medical Center, Dallas, TX, USA.
Department of Neurology, 23534Houston Methodist Hospital, Houston, TX, USA.
Neurorehabil Neural Repair. 2022 Sep;36(9):596-602. doi: 10.1177/15459683221088861. Epub 2022 Aug 4.
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).
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.
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.
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.
脑刺激是促进中风后康复的辅助策略。在这里，我们评估了纳入/排除标准在德克萨斯大学西南分校（UTSW）的一个种族/民族多样化的急性中风服务中对经颅直流电刺激（tDCS）试验入组的影响。
3124 名（59.7±14.5 岁）种族/民族多样化（38.4%非西班牙裔白人（W），22%西班牙裔（H），33.5%非裔美国人（AA），2.3%亚洲人（A））的患者在 UTSW 的急性中风服务中接受了筛选。前瞻性记录了人口统计学、中风特征和排除原因。
2327 名（74.5%）患者经证实患有中风。只有 44 名（1.9%）符合条件。排除的原因按重要性顺序排列如下：（1）上肢（UE）运动障碍的程度，（2）既往中风（s），（3）出血性中风，（4）精神疾病或无法听从指示，（5）年龄较大，其中（2）和（4）在 AA 患者中更为常见，但在其他少数族裔中则不然。44 名符合条件的患者中有 31 名（W 1.68%，H 1.37%，AA.77%，A 3.774%）被纳入。90.5%的经证实的中风患者没有刺激的禁忌症。
有 3 个主要结论：（a）运动恢复脑刺激试验纳入的主要限制是 UE 运动障碍的程度和中风病变特征，（b）大多数中风患者可以用 tDCS 进行刺激而没有安全问题，（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。
