Using Dalfampridine to Improve Recovery in Spinal Cord Injury Patients
Effects of 4-AP on Functional Recovery After Spinal Cord Injury
This study is testing if the drug Dalfampridine, combined with special exercises, can help people with spinal cord injuries recover better movement in their legs.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 44 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Shirley Ryan AbilityLab Academic / other |
| Locations | 1 site (Chicago, Illinois) |
| Trial ID | NCT05447676 on ClinicalTrials.gov |
What this trial studies
This study aims to enhance lower limb motor function recovery in individuals with spinal cord injury (SCI) by using the FDA-approved drug Dalfampridine (4-AP) in conjunction with Spike-timing-dependent plasticity (STDP) stimulation and limb training. The approach combines pharmacological treatment with targeted exercise to promote neuroplasticity and improve rehabilitation outcomes. Participants will undergo training designed to elicit STDP while receiving either the active drug or a placebo. The hypothesis is that this combination will lead to greater improvements in motor function compared to standard rehabilitation methods.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-85 with spinal cord injuries at or above L2, who can perform small muscle contractions.
Not a fit: Patients with uncontrolled medical conditions, significant cognitive impairments, or a history of seizures may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve mobility and quality of life for patients with spinal cord injuries.
How similar studies have performed: Previous studies have shown positive effects of Dalfampridine on motor function rehabilitation in chronic SCI, suggesting potential for success with this combined approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Chicago, Illinois
- Shirley Ryan Abilitylab — Chicago, Illinois, United States (Recruiting)
Study contacts
- Principal investigator: Monica A Perez, PT, PhD — Shirley Ryan Ability Lab
- Study coordinator: Monica A Perez, PT, PhD
- Email: mperez04@sralab.org
- Phone: 312-238-2886
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.