The Shirley Ryan AbilityLab, Northwestern University Feinberg School of Medicine, Chiago, IL (R.L.H., L.M.R.)Burke Neurological Institute, Weill Cornell Neurology, White Plains, NY (D.E.)Department of Rehabilitation, Exercise and Nutrition Sciences, University of Cincinnati, OH (K.D.)Spaulding Rehabilitation Hospital, Harvard Medical School, Boston, MA (F.F.)Department of Rehabilitation and Regenerative Medicine, Columbia University Medical Center, New York, NY (J.S.)Nexstim Corporation, Helsinki, Finland (J.L.)Shepherd Center, Clinical Research, Atlanta, GA (F.V.)Baylor College of Medicine, Physical Medicine and Rehabilitation, TIRR Memorial Herrmann, Houston, TX (A.D.-S.)Physical Medicine and Rehabilitation, Ohio State University, Columbus (M.B.)Kentucky Neuroscience Institute, University of Kentucky, Lexington (L.B.G.)Physical Medicine and Rehabilitation, University of Texas Health Science Center, TIRR Memorial Herrmann, Houston (G.E.F.)Mayo Clinic Arizona, Mayo Clinic Hospital, Physical Medicine and Rehabilitation, Phoenix (C.L.K.)USC Neurorestoration Center, Rancho Los Amigos National Rehabilitation Center, Los Angeles, CA (C.Y.L.).Abilitylab-Northwestern University Feinberg School of Medicine, Chicago, ILSpaulding Rehabilitation Hospital-Research Institute, Physical Medicine and Rehabilitation, Charlestown, MAThe Ohio State University, Physical Medicine and Rehabilitation, Columbus, OHBurke Medical Research Institute/Weill Cornell Neurology, White Plains, NYColumbia University Medical Center, Rehabilitation and Regenerative Medicine, New York, NYShepherd Center, Clinical Research, Atlanta, GAUniversity of Cincinnati. College of Rehabilitation Sciences, Cincinnati, OHIndiana University Neuroscience Center of Excellence, Physical Medicine and Rehabilitation, Indianapolis, IN
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Background and Purpose─We aimed to determine whether low-frequency electric field navigated repetitive transcranial magnetic stimulation to noninjured motor cortex versus sham repetitive transcranial magnetic stimulation avoiding motor cortex could improve arm motor function in hemiplegic stroke patients when combined with motor training.Methods─Twelve outpatient US rehabilitation centers enrolled participants between May 2014 and December 2015. We delivered 1 Hz active or sham repetitive transcranial magnetic stimulation to noninjured motor cortex before each of eighteen 60-minute therapy sessions over a 6-week period, with outcomes measured at 1 week and 1, 3, and 6 months after end of treatment. The primary end point was the percentage of participants improving ≥5 points on upper extremity Fugl-Meyer score 6 months after end of treatment. Secondary analyses assessed changes on the upper extremity Fugl-Meyer and Action Research Arm Test and Wolf Motor Function Test and safety.Results─Of 199 participants, 167 completed treatment and follow-up because of early discontinuation of data collection. Upper extremity Fugl-Meyer gains were significant for experimental (P<0.001) and sham groups (P<0.001). Sixty-seven percent of the experimental group (95% CI, 58%–75%) and 65% of sham group (95% CI, 52%–76%) improved ≥5 points on 6-month upper extremity Fugl-Meyer (P=0.76). There was also no difference between experimental and sham groups in the Action Research Arm Test (P=0.80) or the Wolf Motor Function Test (P=0.55). A total of 26 serious adverse events occurred in 18 participants, with none related to the study or device, and with no difference between groups.Conclusions─Among patients 3 to 12 months poststroke, goal-oriented motor rehabilitation improved motor function 6 months after end of treatment. There was no difference between the active and sham repetitive transcranial magnetic stimulation trial arms.Clinical Trial Registration─URL: https://www.clinicaltrials.gov. Unique identifier: NCT02089464.