Dalfampridine + Stimulation/Exercise for Spinal Cord Injury
Trial Summary
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
The trial requires that you stop taking certain medications, specifically those acting on the central nervous system that lower the seizure threshold, as well as Bupropion, Dolutegravir, Lacosamide, Trilaciclib, or PR Interval prolonging drugs.
What data supports the effectiveness of the drug Dalfampridine for spinal cord injury?
Research shows that 4-aminopyridine (4-AP), the active ingredient in Dalfampridine, may improve walking and nerve function in people with spinal cord injuries. Additionally, Dalfampridine has been shown to improve walking speed in patients with multiple sclerosis, suggesting its potential to help with similar issues in spinal cord injury.12345
Is the combination of Dalfampridine and exercise safe for humans?
Dalfampridine, also known as 4-aminopyridine, has been studied for safety in people with multiple sclerosis and spinal cord injury. It is generally well tolerated, but side effects can include urinary tract infections, insomnia, headache, dizziness, and in rare cases, seizures. Exercise and physical activity are generally safe and beneficial for most people, but it's important to consult with a healthcare provider before starting any new treatment or exercise program.35678
How is the drug dalfampridine unique for treating spinal cord injury?
Dalfampridine is unique because it is a potassium channel blocker that helps improve nerve signal conduction, which can enhance walking ability in patients with spinal cord injury. It is also used in multiple sclerosis for similar purposes, making it a novel approach for spinal cord injury treatment.156910
Research Team
Monica Perez, PhD
Principal Investigator
Shirley Ryan Ability Lab
Eligibility Criteria
This trial is for men and women aged 18-85 with spinal cord injury (SCI) at or above L2, who are at least 4 weeks post-injury. They must be able to slightly move their hip flexor or dorsiflexion muscles. Excluded are those with a history of head injury, stroke, seizures, epilepsy, renal impairment, certain medication use (affecting the CNS), metal in the skull, uncontrolled medical issues, pre-existing debilitating diseases or mental health conditions.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Dalfampridine (4-AP) combined with STDP stimulation and limb training for functional recovery of lower-limb muscles
Follow-up
Participants are monitored for safety and effectiveness after treatment
Open-label extension (optional)
Participants may opt into continuation of treatment long-term
Treatment Details
Interventions
- Dalfampridine
- Exercise training
- Placebo drug
- STDP stimulation
Dalfampridine is already approved in United States, European Union for the following indications:
- Improvement of walking in adults with multiple sclerosis
- Improvement of walking in adults with multiple sclerosis
Find a Clinic Near You
Who Is Running the Clinical Trial?
Shirley Ryan AbilityLab
Lead Sponsor
National Institute of Neurological Disorders and Stroke (NINDS)
Collaborator