Recruiting
Phase 1
Phase 2

4-AP

Sponsor:

Shirley Ryan AbilityLab

Code:

NCT06853015

Conditions

SCI - Spinal Cord Injury

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Dalfampridine

Placebo

STDP stimulation

Exercise training

Study Details

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.

Conditions

SCI - Spinal Cord Injury

Study ID

NCT06853015

Start date

Feb 1, 2025

Status verified date

Jun, 2026

Completion date

Dec 30, 2026

Anticipated

Primary completion date

Mar 1, 2026

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

27 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 4-AP(AM) + STDP stimulation + training + 4-AP(PM)

The effects of the functional recovery of the lower-limb muscles will be determined after 40 sessions of twice-daily-dosing 4-AP, STDP stimulation and training.

placebo comparator: Placebo(AM) + STDP stimulation + training + Placebo(PM)

The effects of the functional recovery of the lower-limb muscles will be determined after 40 sessions of twice-daily-dosing Placebo, STDP stimulation and training.

Interventions

Dalfampridine

The study drug (4-AP) will be administered as a 10 mg dose twice a day.

Placebo

The placebo provided by the SRAL pharmacy that looks identical to the 4-AP, will be administered twice a day.

STDP stimulation

Paired stimulation will be given to the spinal cord and to peripheral nerves so that the signals are received at the spinal cord at a specific interval.

Exercise training

Lower-limb exercises will involve over-ground walking, treadmill, walking and stair climbing training.

Primary outcome measure

  • Change in TMEPs [ Time Frame: TMEPs measured at baseline, at 6 weeks (post 20 sessions), and at 12 weeks (post 40 sessions). ]
  • Change in MVC [ Time Frame: MVC measured at baseline, at 6 weeks (post 20 sessions), and at 12 weeks (post 40 sessions). ]

Central Contacts and Locations

Central contacts

Monica Perez, PT, PhD

312-238-2886mperez04@sralab.org

Bing Chen, PhD

312-238-7895bchen03@sralab.org

Locations

Shirley Ryan Abilitylab

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Monica Perez, PT, PhD

312-238-2886mperez04@sralab.org

More Information

Sponsor

Shirley Ryan AbilityLab

Last update posted

Jun 3, 2026

Last verified

Jun, 2026

Keywords

  • spinal cord injury
  • neurostimulation
  • 4-AP
  • rehabilitation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Shirley Ryan AbilityLab on 2026-06-03.