NCT06853015 Double Dose 4-AP on Functional Recovery After Spinal Cord Injury
| NCT ID | NCT06853015 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Shirley Ryan AbilityLab |
| Condition | SCI - Spinal Cord Injury |
| Study Type | INTERVENTIONAL |
| Enrollment | 27 participants |
| Start Date | 2025-02-01 |
| Primary Completion | 2026-03-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 27 participants in total. It began in 2025-02-01 with a primary completion date of 2026-03-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Monica Perez, PT, PhD
PRINCIPAL INVESTIGATOR
Shirley Ryan Ability Lab
Frequently Asked Questions
Who can join the NCT06853015 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 85 Years, studying SCI - Spinal Cord Injury. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06853015 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06853015 currently recruiting?
Yes, NCT06853015 is actively recruiting participants. Contact the research team at mperez04@sralab.org for enrollment information.
Where is the NCT06853015 trial being conducted?
This trial is being conducted at Chicago, United States.
Who is sponsoring the NCT06853015 clinical trial?
NCT06853015 is sponsored by Shirley Ryan AbilityLab. The principal investigator is Monica Perez, PT, PhD at Shirley Ryan Ability Lab. The trial plans to enroll 27 participants.