Shirley Ryan AbilityLab
The purpose of this study is to test a strategy to potentiate functional recovery of lower limb motor function in individuals with spinal cord injury (SCI). The FDA approved drug, Dalfampridine (4-AP). 4-AP will be used twice-daily in combination of Spike-timing-dependent plasticity (STDP) stimulation and STDP stimulation with limb training.
Currently, research has shown that 4-AP has a positive effect on sensory and motor function rehabilitation in humans with chronic SCI in addition to decreasing recorded spasticity, increased sensation, and decreased pain. A pharmacokinetic study showed that twice-daily administration of sustained release 4-AP maintains a steadier plasma concentration. Utilizing limb training to promote recovery of motor function is enhanced by eliciting STDP in the limbs. An important strength of this aim is the combination of training and STDP, which aims to enhance the beneficial effects of motor training by…
Inclusion Criteria: * Male and females between ages 18-85 years * SCI 6 months post injury * Spinal Cord injury at or above L2 * ASIA A, B, C, or D, complete or incomplete * The ability to perform a small visible contraction with dorsiflexion and hip flexor muscles Exclusion Criteria: * Uncontrolled medical problems including pulmonary, cardiovascular or orthopedic disease * Any history of renal impairment * Any debilitating disease prior to the SCI that caused exercise intolerance * Premorbid, ongoing major depression or psychosis, altered cognitive status * History of head injury or strok…
The study drug (4-AP) will be administered as a 10 mg dose twice a day.
The placebo provided by the SRAL pharmacy that looks identical to the 4-AP, will be administered twice a day.
Paired stimulation will be given to the spinal cord and to peripheral nerves so that the signals are received at the spinal cord at a specific interval.
Lower-limb exercises will involve over-ground walking, treadmill, walking and stair climbing training.
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