Who: Adults, age 18-99 with ASIA A-D traumatic thoracic injury without lower motor neuron involvement. To participate, you must be at least six months out from the injury and be in satisfactory general health.
What: You will be asked to participate in a four-week cycling program at the International Center for Spinal Cord Injury (ICSCI). At the beginning of the program, you will be assigned to either a functional electric stimulation (FES) cycling group or a passive-cycling group. The program will consist of 12 cycling sessions (three times/week, one hour/session). On the day of (or on a separate day close to) your 1st, 6th, and 12th cycling visit, you will also receive an ASIA neurological exam, a SCIM functional evaluation, and a structural and functional magnetic resonance imaging of the brain and spinal cord (total of three ASIA exams and three MRIs). During the imaging, we will ask you to lie still in the MRI while we take pictures of your brain and spinal cord. The neurological exam and imaging will last approximately 60 minutes each (120 minutes total). If you have your own FES RT300 cycling bike, you will have an option to cycle at home using televisits. The screening and MRI visits will still be conducted at KKI in person.
Risks: The effects of magnetic fields in an MRI scanner have been extensively studied, and there are no known significant risks with an MRI exam.
Benefits: There is no direct benefit to you from being in this study, but it may benefit others in the future by improving methods for the study of nervous system structure and function. If you complete the study, you will be reimbursed $150 for participation and an additional $60 for the cost of transportation (total of $210; in the form of a check).
Where: The International Center for Spinal Cord Injury at Kennedy Krieger Institute (707 North Broadway, Baltimore). You will have an option to perform the FES cycling in the Maple Lawn Campus (11830 West Market Place, Suite P, Fulton, MD 20759).
Contact: Research coordinator at the International Center for Spinal Cord Injury, 443-923-9235 or clinicaltrials@spinalcordrecovery.org.
