Study of Twice-Daily Dalfampridine 4-AP Combined With Stimulation and Training to Improve Lower Limb Function After Spinal Cord Injury

What this Trial Is About

Researchers are investigating ways to improve lower limb motor function recovery in people with spinal cord injury SCI. This study evaluates the effects of the FDA-approved drug Dalfampridine 4-AP taken twice daily, combined with spike-timing-dependent plasticity STDP stimulation and limb training. The research focuses on whether adding 4-AP to STDP stimulation and training helps enhance motor function rehabilitation for those with chronic SCI. Participants will receive either twice-daily doses of 10 mg 4-AP or a matching placebo, along with STDP stimulation and lower-limb exercise training involving walking and stair climbing. The study involves 40 sessions of this combined treatment to assess functional recovery. The design includes two groups one receiving 4-AP with STDP and training, and the other receiving placebo with STDP and training. During the study, researchers will measure changes in motor evoked potentials TMEPs, maximal voluntary contraction MVC, walking tests, neurological classification, sensory thresholds, and quality of life surveys at baseline, 6 weeks after 20 sessions, and 12 weeks after 40 sessions. MRI scans of motor pathways will be done at baseline and after 12 weeks. The study is randomized and triple-blinded, with participation lasting about 12 weeks.

Double Dose 4-AP on Functional Recovery After Spinal Cord Injury