A pivotal, prospective, multi-center, randomized, controlled, double-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. 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
199
Mayo Clinic
Phoenix, Arizona, United States
Rancho Los Amigos National Rehabilitation Center
Downey, California, United States
Shepherd Rehabilitation Center
Atlanta, Georgia, United States
Upper Extremity Fugl-Meyer Score
Number of Participants with Improvement in Upper Extremity Fugl-Meyer (UEFM) Score at 6 Months Post-treatment equal or exceeding the Minimal Clinically Important Difference (MCID) of 5 points (MCID).
Time frame: Baseline - 6 months post-treatment
Arm-Research Action Test (ARAT)
Scale minimum 0, maximum 57. Greater values indicate better motor function.
Time frame: Baseline - 6 months post-treatment
Wolf Motor Function Test
Time in seconds to perform test tasks. Shorter time indicates better motor function.
Time frame: Baseline - 6 months post-treatment
NIH Stroke Scale (NIHSS)
Scale is a measure of neurological functioning, with higher scores reflecting greater deficit (minimum 0,maximum 42)
Time frame: Baseline - 6 months post-treatment
Chedoke-McMaster Stroke Assessment (CMSA)
Scale minimum 1, maximum 7. Higher values indicate better motor function of hand.
Time frame: Baseline - 6 months post-treatment
Stroke Impact Scale (SIS)
Score used to detect the consequences of stroke on physical functioning and activities of daily living. The SIS-16 is a 16 item survey that inquires about daily tasks performed over the previous 2 weeks. Scale minimum 16, maximum 80. Higher values indicate better function
Time frame: Baseline - 6 months post-treatment
Patient Health Questionnaire (PHQ9)
The possible presence and severity of depression will be assessed using the Patient Health Questionnaire (PHQ9). PHQ9 is a scale with a minimum value 0 and maximum of 27. Higher values indicate more depressed mood
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Rehabilitation Institute of Chicago
Chicago, Illinois, United States
Indiana University Indianapolis
Indianapolis, Indiana, United States
Spaulding Rehabilitation Hospital
Boston, Massachusetts, United States
Columbia Cornell New York Presbyterian Hospital
New York, New York, United States
Burke Medical Research Institute, Weill Cornell Neurology
White Plains, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
University of Cincinnati
Cincinnati, Ohio, United States
...and 2 more locations
Time frame: Baseline - 6 months post-treatment
Quality of Life Assessment: EuroQol EQ-5D Scale
The EuroQoL EQ-5D is a visual analog scale scale from 0 (minimum) to 100 (maximum) assessing quality of life. Higher values indicate better quality of life.
Time frame: Baseline - 6 months post-treatment