Epidural Stimulation After Neurologic Damage: Long-Term Outcomes

Not Applicable

Recruiting

• Conditions: SCI - Spinal Cord Injury
• Interventions: Device: Epidural Spinal Cord Stimulation

• Registration Number: NCT05705453
• Lead Sponsor: University of Minnesota

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.

Study Timeline

• Study First Submitted: 2023-01-04
• Study First Submitted QC: 2023-01-20
• Study First Posted: 2023-01-30
• Study Start: 2023-03-01
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-21
• Last Update Posted: 2025-03-24
• Primary Completion: 2033-04-01
• Study Completion: 2034-04-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Volitional EMG power	Epidural Spinal Cord Stimulation	Assessing the change in volitional EMG power during the Brain Motor Control Assement (BMCA) between nonstimulation baseline and stimulation.

Primary Outcome Measures

Name	Time	Method
Change in Volitional electromyography (EMG) power	10 years	The measurement of volitional change using EMG during the Brain Motor Control assessment between nonstimulation baseline and stimulation

Secondary Outcome Measures

Name	Time	Method
Prediction of power preferences	10 years	Prediction of power of preference models built based on evaluations of stimulation settings.

Trial Locations

Locations (1)

Hennepin County Medical Center; 🇺🇸 Minneapolis, Minnesota, United States