A prospective, multi-center, randomized, sham-controlled, blinded study combining active Nexstim NBS-guided 1Hz rTMS or sham-rTMS targeting the healthy hemisphere with standardized task oriented rehabilitation will be conducted in patients with post-stroke motor impairment of the upper limb. The therapy will be provided for 6 weeks and primary outcome assessed 6 months later.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
60
Nexstim NBS guided active rTMS + standardized task-oriented therapy
Nexstim NBS guided sham rTMS + standardized task-oriented therapy
Rancho Los Amigos National Rehabilitation Center
Downey, California, United States
Rehabilitation Institute of Chicago
Chicago, Illinois, United States
Spaulding Rehabilitation Hospital
Boston, Massachusetts, United States
Burke Medical Research Institute, Weill Cornell Neurology
White Plains, New York, United States
Upper Extremity Fugl-Meyer Score
Range 0 to 65. HIgher scores indicate better function. Minimal clinically important difference = change of 5 points or more on scale. Outcome measure = proportion of patients in treatment arm gaining at least 5 points on scale between baseline and 6 months after end of treatment.
Time frame: Change from baseline to 6 months after end of treatment.
Upper Extremity Fugl-Meyer Score
Range 0-65. HIgher scores indicate better function.
Time frame: Change in score from baseline to 6 months after end of treatment
Arm-Research Action Test (ARAT)
Range 0 to 57. Higher scores indicate better function.
Time frame: Change in score from baseline to 6 months after end of treatment.
NIH Stroke Scale (NIHSS)
National Institute of Health Stroke Scale - Motor Arm. Range 0 to 4. Lower score indicates better function.
Time frame: Change in score from baseline to 6 months after end of treatment
Quality of Life Assessment: EQ-5D
EuroQoL - EQ-5D score. Range 0 to 100. HIgher numbers indicate better quality of life.
Time frame: Change in score from baseline to 6 months after end of treatment
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University of Cincinnati
Cincinnati, Ohio, United States