Effects of 4-AP on Functional SCI Recovery

• Status: Recruiting
• Trial end date: 2025-06-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shirley Ryan AbilityLab
• Collaborator: National Institute of Neurological Disorders and Stroke (NINDS)
• Treatments: 4-Aminopyridine

Criteria

Inclusion Criteria:

• 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

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