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
Shirley Ryan AbilityLab
27 participants
Feb 1, 2025
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria5
- 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 Criteria14
- 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
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Interventions
The study drug (4-AP) will be administered as a 10 mg dose twice a day.
The placebo provided by the SRAL pharmacy that looks identical to the 4-AP, will be administered twice a day.
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.
Lower-limb exercises will involve over-ground walking, treadmill, walking and stair climbing training.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06853015