Epidural Stimulation After Neurologic Damage: Long-Term Outcomes (LTO)

University of Minnesota (UMN)

Status: Enrolling

Conditions: SCI - Spinal Cord Injury

Treatments: Device: Epidural Spinal Cord Stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT05705453

IRB-FY2022-365

Details and patient eligibility

About

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

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 22+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Volitional EMG power

Experimental group

Description:

Assessing the change in volitional EMG power during the Brain Motor Control Assement (BMCA) between nonstimulation baseline and stimulation.

Treatment:

Device: Epidural Spinal Cord Stimulation