Using Dalfampridine to Improve Recovery After Spinal Cord Injury

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: mperez04@sralab.org
• Phone: 312-238-2886

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.