Epidural Stimulation After Neurologic Damage: Long-Term Outcomes

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.

Conditions

SCI - Spinal Cord Injury

Study Overview

Study Details

Study overview

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

Epidural Stimulation After Neurologic Damage: Long-Term Outcomes

Epidural Stimulation After Neurologic Damage: Long-Term Outcomes

Condition
SCI - Spinal Cord Injury
Intervention / Treatment

-

Contacts and Locations

Minneapolis

Hennepin County Medical Center, Minneapolis, Minnesota, United States, 55415

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

  • * 22 years of age or older
  • * Able to undergo the informed consent process
  • * Stable spinal cord injury
  • * International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) neurologic level of injury below C5
  • * No ventilator dependency within the last year
  • * American Spinal Injury Association (AISA) imparement scale"A" or "B" in the absence of spinal cord stimulation
  • * Medically stable in the judgment of the Principal investigator
  • * 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
  • * Has an existing and functional implanted spinal cord stimulator system that is FDA approved and can be corroborated by hospital documentation
  • * Spinal imaging of the stimulator system
  • * 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
  • * Use of botulinum toxin (Botox) injections in the previous six months
  • * Clinically significant mental illness in the judgment of the principal investigator
  • * Other conditions or medications that would make the subject unable to participate in testing/rehabilitation in the judgment of the principal investigator
  • * Nonfunctional spinal cord stimulator or near end-of-life, determined by the PI
  • * Current Pregnancy
  • * Current pain relief from the spinal cord stimulator if the indication for implantation was for management of chronic pain.

Ages Eligible for Study

22 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of Minnesota,

David Darrow, MD, PRINCIPAL_INVESTIGATOR, University of Minnesota

Study Record Dates

2034-04-01