NCT06853015

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

Effects of Twice-daily Dosing 4-AP on Functional Recovery After Spinal Cord Injury

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 27 (estimated)
• Sponsor: Shirley Ryan AbilityLab · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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 promoting plasticity in the corticospinal pathway. Training effects on physiological pathways will be explored and correlated with lower limb motor function. We hypothesize that introducing 4-AP into the STDP stimulation and STDP stimulation with training will further improve motor function rehabilitation in patients with chronic SCI.

Conditions

• SCI - Spinal Cord Injury

Interventions

Type	Name	Description
DRUG	Dalfampridine	The study drug (4-AP) will be administered as a 10 mg dose twice a day.
DRUG	Placebo	The placebo provided by the SRAL pharmacy that looks identical to the 4-AP, will be administered twice a day.
OTHER	STDP stimulation	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.
BEHAVIORAL	Exercise training	Lower-limb exercises will involve over-ground walking, treadmill, walking and stair climbing training.

Timeline

• Start date: 2025-02-01
• Primary completion: 2026-03-01
• Completion: 2026-03-01
• First posted: 2025-02-28
• Last updated: 2025-04-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study