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Recruiting NCT05705453

Epidural Stimulation After Neurologic Damage: Long-Term Outcomes

Trial Parameters

Condition SCI - Spinal Cord Injury
Sponsor University of Minnesota
Study Type INTERVENTIONAL
Phase N/A
Enrollment 50
Sex ALL
Min Age 22 Years
Max Age N/A
Start Date 2023-03-01
Completion 2033-04-01
Interventions
Epidural Spinal Cord Stimulation

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.

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 princip

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