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Not Yet Recruiting
NCT05705453
Epidural Stimulation After Neurologic Damage: Long-Term Outcomes
Conditions: SCI - Spinal Cord Injury
Sex: All
Ages: 22 Years – N/A
Phase: NA
Enrollment: 50
Sponsor: University of Minnesota
Location: United States
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 olderAble to undergo the informed consent processStable spinal cord injuryInternational Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) neurologic level of injury below C5No ventilator dependency within the last yearAmerican Spinal Injury Association (AISA) imparement scale"A" or "B" in the absence of spinal cord stimulationMedically stable in the judgment of the Principal investigatorGreater than 1 year since initial injury and at least 6 months from any required spinal instrumentation and 2 months from spinal cord stimulator surgeryHas an existing and functional implanted spinal cord stimulator system that is FDA approved and can be corroborated by hospital documentationSpinal imaging of the stimulator systemExclusion 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 investigatorUse of botulinum toxin (Botox) injections in the previous six monthsClinically significant mental illness in the judgment of the principal investigatorOther conditions or medications that would make the subject unable to participate in testing/rehabilitation in the judgment of the principal investigatorNonfunctional spinal cord stimulator or near end-of-life, determined by the PICurrent PregnancyCurrent pain relief from the spinal cord stimulator if the indication for implantation was for management of chronic pain.
Source: ClinicalTrials.gov (NCT05705453). StuddyBuddy aggregates publicly available trial information.