RECRUITING

Epidural Stimulation After Neurologic Damage: Long-Term Outcomes

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Conditions

SCI - Spinal Cord Injuryspinal cord stimulationepidural stimulation

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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

This study will evaluate the long-term effect of chronic spinal cord stimulation to restore volitional movement for patients with chronic spinal cord injuries.

Official Title

Epidural Stimulation After Neurologic Damage: Long-Term Outcomes

Quick Facts

Study Start:2023-03-01
Study Completion:2034-04-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05705453

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:22 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 22 years of age or older
  2. * Able to undergo the informed consent process
  3. * Stable spinal cord injury
  4. * International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) neurologic level of injury below C5
  5. * No ventilator dependency within the last year
  6. * American Spinal Injury Association (AISA) imparement scale"A" or "B" in the absence of spinal cord stimulation
  7. * Medically stable in the judgment of the Principal investigator
  8. * Greater than 1 year since initial injury and at least 6 months from any required spinal instrumentation and 2 months from spinal cord stimulator surgery
  9. * Has an existing and functional implanted spinal cord stimulator system that is FDA approved and can be corroborated by hospital documentation
  10. * Spinal imaging of the stimulator system
  1. * Current and anticipated need for opioid pain medications or pain that would prevent full participation in the rehabilitation program in the judgment of the principal investigator
  2. * Use of botulinum toxin (Botox) injections in the previous six months
  3. * Clinically significant mental illness in the judgment of the principal investigator
  4. * Other conditions or medications that would make the subject unable to participate in testing/rehabilitation in the judgment of the principal investigator
  5. * Nonfunctional spinal cord stimulator or near end-of-life, determined by the PI
  6. * Current Pregnancy
  7. * Current pain relief from the spinal cord stimulator if the indication for implantation was for management of chronic pain.

Contacts and Locations

Study Contact

Study Coordinator
CONTACT
612-873-9113
estand@umn.edu
Study Coordinator
CONTACT
612-873-9113
rnl@umn.edu

Principal Investigator

David Darrow, MD
PRINCIPAL_INVESTIGATOR
University of Minnesota

Study Locations (Sites)

Hennepin County Medical Center
Minneapolis, Minnesota, 55415
United States

Collaborators and Investigators

Sponsor: University of Minnesota

  • David Darrow, MD, PRINCIPAL_INVESTIGATOR, University of Minnesota

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 Date2023-03-01
Study Completion Date2034-04-01

Study Record Updates

Study Start Date2023-03-01
Study Completion Date2034-04-01

Terms related to this study

Keywords Provided by Researchers

  • spinal cord stimulation
  • epidural stimulation

Additional Relevant MeSH Terms

  • SCI - Spinal Cord Injury