RecruitingNot ApplicableNCT05705453

Epidural Stimulation After Neurologic Damage: Long-Term Outcomes

Sponsor

University of Minnesota

Enrollment

50 participants

Start Date

May 11, 2023

Study Type

INTERVENTIONAL

Conditions

SCI - Spinal Cord Injury

Summary

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

Eligibility

Min Age: 22 Years

Inclusion Criteria10

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

Exclusion Criteria7

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.