Effects of 4-AP on Functional SCI Recovery

Completed · Early Phase 1 · Has a placebo group

Conditions studied: Spinal Cord Injury

In brief

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 in combination of Spike-timing-dependent plasticity (STDP) stimulation and STDP stimulation with limb training.

Key facts

Study ID

NCT05447676

Run by

Shirley Ryan AbilityLab

People needed

26

Starts

2022-06-30

Expected to finish

2025-06-30

Last updated by the study team

2026-06-03

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male and females between ages 18-85 years
• SCI at least 4 weeks post injury
• Spinal Cord injury at or above L2
• ASIA A,B,C, or D, complete or incomplete
• Possess the following abilities
• The ability to perform a small visible contraction with dorsiflexion and hip flexor muscles

You may not qualify if…

• 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

Where it is running

• Shirley Ryan Abilitylab — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

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