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Double Dose 4-AP on Functional Recovery After Spinal Cord Injury
RecruitingPhase 1/2
Effects of Twice-daily Dosing 4-AP on Functional Recovery After Spinal Cord Injury
Who can join
Ages 18 to 85 · All sexes
Full eligibility criteria
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 stroke * Vascular, traumatic, tumoral, infectious, or metabolic lesion of the brain, even without history of seizure, and without anticonvulsant medication * History of seizures or epilepsy * Receiving drugs acting primarily on the central nervous system, which lower the seizure threshold (see appendix 2) * Pregnant females * If a women of child bearing age is unsure of the pregnancy, and does not want to take the pregnancy test * Ongoing cord compression or a syrinx in the spinal cord or who suffer from a spinal cord disease such as spinal stenosis, spina bifida, MS, or herniated disk * Metal plate in skull * Individuals with scalp shrapnel, cochlear implants, or aneurysm clips * Individuals taking Bupropion, Dolutegravir, Lacosamide, Trilaciclib, or PR Interval prolonging drugs
About the study
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.
What is being tested
- Dalfampridine (drug)
- Placebo (drug)
- STDP stimulation (other)
- Exercise training (behavioral)
Sponsor: Shirley Ryan AbilityLab · Participants: 27 · Started: Feb 1, 2025
Contact the study team
- Monica Perez, PT, PhD · Phone: 312-238-2886
- Bing Chen, PhD · Phone: 312-238-7895
Official record on ClinicalTrials.gov — NCT06853015
Locations in the U.S.
| Illinois | Shirley Ryan Abilitylab, Chicago |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.