Timea Hodics1,2, Leonardo G Cohen3, John C Pezzullo4, Karen Kowalske5, Alexander W Dromerick6,7,8. 1. Department of Neurology and Neurotherapeutics, 12334University of Texas Southwestern Medical Center, Dallas, TX, USA. 2. Department of Neurology, 23534Houston Methodist Hospital, Houston, TX, USA. 3. Human Cortical Physiology and Stroke Neurorehabilitation Section, National Institutes of Health, 35046National Institutes of Neurological Disorders and Stroke, Bethesda, MD, USA. 4. Department of Medicine, 8368Georgetown University Medical Center, Washington, DC, USA. 5. Department of Physical Medicine and Rehabilitation, 12334University of Texas Southwestern Medical Center, Dallas, TX, USA. 6. Department of Rehabilitation Medicine and Neurology, MedStar National Rehabilitation Hospital, Washington, DC, USA. 7. 8368Center for Brain Plasticity and Recovery, Departments of Rehabilitation Medicine and Neurology, Georgetown University Medical Center, Washington, DC USA. 8. Research Division, MedStar National Rehabilitation Hospital, Washington, DC, USA.
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.
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.
Entities:
Keywords:
brain; demographics; disparities; motor; stroke; transcranial direct current stimulation
Authors: Kelsey A Potter-Baker; Corin E Bonnett; Patrick Chabra; Sarah Roelle; Nicole Varnerin; David A Cunningham; Vishwanath Sankarasubramanian; Svetlana Pundik; Adriana B Conforto; Andre G Machado; Ela B Plow Journal: J Stroke Cerebrovasc Dis Date: 2016-02-02 Impact factor: 2.136