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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

Sponsor: Shirley Ryan AbilityLab · Participants: 27 · Started: Feb 1, 2025

Contact the study team

Official record on ClinicalTrials.gov — NCT06853015

Locations in the U.S.

IllinoisShirley 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.