Double Dose 4-AP on Functional Recovery After Spinal Cord Injury

Last updated: April 1, 2025
Sponsor: Shirley Ryan AbilityLab
Overall Status: Active - Recruiting

Phase

1/2

Condition

Spinal Cord Injuries

Treatment

STDP stimulation

Dalfampridine

Placebo

Clinical Study ID

NCT06853015
STU00221545
  • Ages 18-85
  • All Genders

Study 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

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 flexormuscles

Exclusion

Exclusion Criteria:

  • Uncontrolled medical problems including pulmonary, cardiovascular or orthopedicdisease

  • 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, evenwithout history of seizure, and without anticonvulsant medication

  • History of seizures or epilepsy

  • Receiving drugs acting primarily on the central nervous system, which lower theseizure threshold (see appendix 2)

  • Pregnant females

  • If a women of child bearing age is unsure of the pregnancy, and does not want totake the pregnancy test

  • Ongoing cord compression or a syrinx in the spinal cord or who suffer from a spinalcord 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 Intervalprolonging drugs

Study Design

Total Participants: 27
Treatment Group(s): 4
Primary Treatment: STDP stimulation
Phase: 1/2
Study Start date:
February 01, 2025
Estimated Completion Date:
March 31, 2026

Study Description

Currently, research has shown that 4-AP has a positive effect on sensory and motor function rehabilitation in humans with chronic SCI in addition to decreasing recorded spasticity, increased sensation, and decreased pain. A pharmacokinetic study showed that twice-daily administration of sustained release 4-AP maintains a steadier plasma concentration. Utilizing limb training to promote recovery of motor function is enhanced by eliciting STDP in the limbs. An important strength of this aim is the combination of training and STDP, which aims to enhance the beneficial effects of motor training by promoting plasticity in the corticospinal pathway. Training effects on physiological pathways will be explored and correlated with lower limb motor function. We hypothesize that introducing 4-AP into the STDP stimulation and STDP stimulation with training will further improve motor function rehabilitation in patients with chronic SCI.

Connect with a study center

  • Shirley Ryan Abilitylab

    Chicago, Illinois 60611
    United States

    Active - Recruiting

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