Using Dalfampridine to Improve Recovery After Spinal Cord Injury

Effects of Twice-daily Dosing 4-AP on Functional Recovery After Spinal Cord Injury

This study is testing if the drug Dalfampridine can help people with spinal cord injuries recover better movement in their legs when combined with special training.

Quick facts

• Phase: PHASE1; PHASE2
• Study type: Interventional
• Enrollment: 27 (estimated)
• Ages: 18 Years to 85 Years
• Sex: All
• Sponsor: Shirley Ryan AbilityLab (other)
• Locations: 1 site (Chicago, Illinois)
• Trial ID: NCT06853015 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 combination with Spike-timing-dependent plasticity (STDP) stimulation and limb training. Participants will receive either 4-AP or a placebo twice daily while undergoing targeted training to promote neuroplasticity in the corticospinal pathway. The study will explore the effects of this combined approach on motor function rehabilitation and assess physiological changes associated with training. The hypothesis is that the addition of 4-AP will further improve rehabilitation outcomes for patients with chronic SCI.

Who should consider this trial

Good fit: Ideal candidates are males and females aged 18-85 with spinal cord injuries at or above L2, who are at least six months post-injury and can perform small visible muscle contractions.

Not a fit: Patients with uncontrolled medical problems, 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 enhance motor function recovery in patients with spinal cord injuries.

How similar studies have performed: Previous studies have shown positive effects of 4-AP on sensory and motor function rehabilitation in chronic SCI, indicating potential for success with this combined approach.

Eligibility criteria

Inclusion Criteria:

* 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 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 Perez, PT, PhD — Shirley Ryan Ability Lab
• Study coordinator: Monica Perez, PT, PhD

Conditions: SCI - Spinal Cord Injury, spinal cord injury, neurostimulation, 4-AP, rehabilitation