Epidural Stimulation After Neurologic Damage: Long-Term Outcomes

University of Minnesota1 site in 1 country50 target enrollmentMay 11, 2023

ConditionsSCI - Spinal Cord Injury

InterventionsEpidural Spinal Cord Stimulation

Overview

Phase: Not Applicable
Intervention: Epidural Spinal Cord Stimulation
Conditions: SCI - Spinal Cord Injury
Sponsor: University of Minnesota
Enrollment: 50
Locations: 1
Primary Endpoint: Change in Volitional electromyography (EMG) power
Status: Recruiting
Last Updated: 24 days ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Detailed Description

Participants will be enrolled in this study for the duration of 10 years. They will need to come to Minneapolis twice a year for the Brain Motor Control Assessment and will be given different settings within their Spinal Cord Stimulator (SCS) programing.

Registry

clinicaltrials.gov

Start Date

May 11, 2023

End Date

April 1, 2034

Last Updated

24 days ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

University of Minnesota

Responsible Party

Sponsor

Eligibility Criteria

Inclusion 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

Exclusion Criteria

•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.