Restoring Lost Functions after Spinal Cord Injury: Combination Therapy with Dalfampridine and Locomotor Training in Persons with Chronic, Motor Incomplete Spinal Cord Injury
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This is a randomized, double-blind, placebo-controlled clinical trial to determine the efficacy and safety of combination therapy with dalfampridine and locomotor training in persons with chronic, motor incomplete spinal cord injury (SCI). The proposed study combines dalfampridine (sustained-release 4-aminopyridine, AMPYRA™), a drug recently approved by the FDA to improve walking in persons with multiple sclerosis (MS) and that has shown promise in persons with SCI, with locomotor training, a promising rehabilitative intervention that has been shown to improve walking and other functional outcomes in persons with SCI. Forty-six individuals with chronic (=12 months), motor-incomplete, traumatic SCI will be randomly assigned to 10 weeks of double-blind treatment with oral, extended-release dalfampridine (10 mg twice daily) or placebo while simultaneously receiving a standardized protocol of LT (5 sessions per week x 10 weeks = 50 sessions total). Primary efficacy outcome will be the six-minute walk test. Secondary measures will include the 10-meter walk test, timed 25-foot walk test, ambulation, lower extremity motor strength, balance, spasticity, bowel and bladder function, sexual function in women and men, autonomic function, pulmonary function, pain, overall functional ability, participation, quality of life, global life satisfaction, and overall status.