Adam Kirton1, Patrick Ciechanski2, Ephrem Zewdie2, John Andersen2, Alberto Nettel-Aguirre2, Helen Carlson2, Lisa Carsolio2, Mia Herrero2, Jillian Quigley2, Aleksandra Mineyko2, Jacquie Hodge2, Michael Hill2. 1. From the Departments of Pediatrics and Clinical Neurosciences (A.K., A.M.), Cumming School of Medicine, Alberta Children's Hospital Research Institute, University of Calgary; Department of Neurosciences (P.C.) and Hotchkiss Brain Institute (A.K., M.H.), Cumming School of Medicine, University of Calgary; Calgary Pediatric Stroke Program (A.K., P.C., E.Z., H.C., A.M., J.H.) and Department of Pediatrics (A.N.-A.), Alberta Children's Hospital; University of Alberta (J.A.), Glenrose Rehabilitation Hospital, Edmonton; and Clinical Neurosciences (L.C., M.H., J.Q.), Alberta Children's Hospital, Alberta Health Services, Calgary, Canada. adam.kirton@albertahealthservices.ca. 2. From the Departments of Pediatrics and Clinical Neurosciences (A.K., A.M.), Cumming School of Medicine, Alberta Children's Hospital Research Institute, University of Calgary; Department of Neurosciences (P.C.) and Hotchkiss Brain Institute (A.K., M.H.), Cumming School of Medicine, University of Calgary; Calgary Pediatric Stroke Program (A.K., P.C., E.Z., H.C., A.M., J.H.) and Department of Pediatrics (A.N.-A.), Alberta Children's Hospital; University of Alberta (J.A.), Glenrose Rehabilitation Hospital, Edmonton; and Clinical Neurosciences (L.C., M.H., J.Q.), Alberta Children's Hospital, Alberta Health Services, Calgary, Canada.
Abstract
OBJECTIVE: To determine whether the addition of transcranial direct current stimulation (tDCS) to intensive therapy increases motor function in children with perinatal stroke and hemiparetic cerebral palsy. METHODS: This was a randomized, controlled, double-blind clinical trial. Participants were recruited from a population-based cohort with MRI-classified unilateral perinatal stroke, age of 6 to 18 years, and disabling hemiparesis. All completed a goal-directed, peer-supported, 2-week after-school motor learning camp (32 hours of therapy). Participants were randomized 1:1 to 1 mA cathodal tDCS over the contralesional primary motor cortex (M1) for the initial 20 minutes of daily therapy or sham. Primary subjective (Canadian Occupational Performance Measure [COPM]), objective (Assisting Hand Assessment [AHA]), safety, and secondary outcomes were measured at 1 week and 2 months after intervention. Analysis was by intention to treat. RESULTS: Twenty-four participants were randomized (median age 11.8 ± 2.7 years, range 6.7-17.8). COPM performance and satisfaction scores doubled at 1 week with sustained gains at 2 months (p < 0.001). COPM scores increased more with tDCS compared to sham control (p = 0.004). AHA scores demonstrated only mild increases at both time points with no tDCS effects. Procedures were safe and well tolerated with no decrease in either arm function or serious adverse events. CONCLUSION: tDCS trials appear feasible and safe in hemiparetic children. Lack of change in objective motor function may reflect underdosing of therapy. Marked gains in subjective function with tDCS warrant further study. CLINICALTRIALSGOV IDENTIFIER: NCT02170285. CLASSIFICATION OF EVIDENCE: This study provides Class II evidence that for children with perinatal stroke and hemiparetic cerebral palsy, the addition of tDCS to moderate-dose motor learning therapy does not significantly improve motor function as measured by the AHA.
OBJECTIVE: To determine whether the addition of transcranial direct current stimulation (tDCS) to intensive therapy increases motor function in children with perinatal stroke and hemiparetic cerebral palsy. METHODS: This was a randomized, controlled, double-blind clinical trial. Participants were recruited from a population-based cohort with MRI-classified unilateral perinatal stroke, age of 6 to 18 years, and disabling hemiparesis. All completed a goal-directed, peer-supported, 2-week after-school motor learning camp (32 hours of therapy). Participants were randomized 1:1 to 1 mA cathodal tDCS over the contralesional primary motor cortex (M1) for the initial 20 minutes of daily therapy or sham. Primary subjective (Canadian Occupational Performance Measure [COPM]), objective (Assisting Hand Assessment [AHA]), safety, and secondary outcomes were measured at 1 week and 2 months after intervention. Analysis was by intention to treat. RESULTS: Twenty-four participants were randomized (median age 11.8 ± 2.7 years, range 6.7-17.8). COPM performance and satisfaction scores doubled at 1 week with sustained gains at 2 months (p < 0.001). COPM scores increased more with tDCS compared to sham control (p = 0.004). AHA scores demonstrated only mild increases at both time points with no tDCS effects. Procedures were safe and well tolerated with no decrease in either arm function or serious adverse events. CONCLUSION: tDCS trials appear feasible and safe in hemiparetic children. Lack of change in objective motor function may reflect underdosing of therapy. Marked gains in subjective function with tDCS warrant further study. CLINICALTRIALSGOV IDENTIFIER: NCT02170285. CLASSIFICATION OF EVIDENCE: This study provides Class II evidence that for children with perinatal stroke and hemiparetic cerebral palsy, the addition of tDCS to moderate-dose motor learning therapy does not significantly improve motor function as measured by the AHA.
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