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

Description

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

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
SCI - Spinal Cord Injury
Intervention / Treatment

-

Contacts and Locations

Chicago

Shirley Ryan Abilitylab, Chicago, Illinois, United States, 60611

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to 85 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Shirley Ryan AbilityLab,

Monica Perez, PT, PhD, PRINCIPAL_INVESTIGATOR, Shirley Ryan Ability Lab

Study Record Dates

2026-03