RECRUITING

Effects of 4-AP on Functional SCI Recovery

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Conditions

Spinal Cord InjurySCINeural control4-APWalkingNeuroplasticity

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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 in combination of Spike-timing-dependent plasticity (STDP) stimulation and STDP stimulation with limb training.

Official Title

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

Quick Facts

Study Start:2022-06-30
Study Completion:2025-06-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05447676

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.

Ages Eligible for Study:18 Years to 85 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Male and females between ages 18-85 years
  2. * SCI at least 4 weeks post injury
  3. * Spinal Cord injury at or above L2
  4. * ASIA A,B,C, or D, complete or incomplete
  5. * Possess the following abilities
  6. * The ability to perform a small visible contraction with dorsiflexion and hip flexor muscles
  1. * Uncontrolled medical problems including pulmonary, cardiovascular or orthopedic disease
  2. * Any history of renal impairment
  3. * Any debilitating disease prior to the SCI that caused exercise intolerance
  4. * Premorbid, ongoing major depression or psychosis, altered cognitive status
  5. * History of head injury or stroke
  6. * Vascular, traumatic, tumoral, infectious, or metabolic lesion of the brain, even without history of seizure, and without anticonvulsant medication
  7. * History of seizures or epilepsy
  8. * Receiving drugs acting primarily on the central nervous system, which lower the seizure threshold (see appendix 2)
  9. * Pregnant females
  10. * 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
  11. * Metal plate in skull
  12. * Individuals with scalp shrapnel, cochlear implants, or aneurysm clips
  13. * Individuals taking Bupropion, Dolutegravir, Lacosamide, Trilaciclib, or PR Interval prolonging drugs

Contacts and Locations

Study Contact

Monica A Perez, PT, PhD
CONTACT
312-238-2886
mperez04@sralab.org
Sri Ramya Vemulakonda, M.B.B.S
CONTACT
3122382993
svemulakon@sralab.org

Principal Investigator

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

Study Locations (Sites)

Shirley Ryan Abilitylab
Chicago, Illinois, 60611
United States

Collaborators and Investigators

Sponsor: Shirley Ryan AbilityLab

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-06-30
Study Completion Date2025-06-30

Study Record Updates

Study Start Date2022-06-30
Study Completion Date2025-06-30

Terms related to this study

Keywords Provided by Researchers

  • SCI
  • Neural control
  • 4-AP
  • Walking
  • Neuroplasticity

Additional Relevant MeSH Terms

  • Spinal Cord Injury