NCT05966896

Epidural Stimulation to Restore Voluntary Movement Following Spinal Cord Injury

Epidural Stimulation to Restore Voluntary Movement Following Spinal Cord Injury: Spared Fibers Proof-of-concept Study

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 2 (estimated)
• Sponsor: University of Colorado, Denver · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

This proof-of-concept case series will prospectively use magnetic resonance imaging (MRI) evidence of spared spinal cord neural fibers to guide the selection of 2 research participants to receive a surgically implanted epidural stimulator with the goal of restoring voluntary movement after spinal cord injury (SCI). Because MRI evidence of spared spinal cord neural fibers demonstrated significant relationships with responsiveness to epidural stimulation in SCI in retrospective studies, the proposed study is a traditional feasibility study - a prospective investigation to be used to capture preliminary safety and effectiveness information to determine if MRI can/should be used in planning a future pivotal study.

Detailed description

This is an investigator-initiated proof of concept study performed at the University of Colorado Anschutz Medical Campus (CU Anschutz). This 2-case proof-of-concept study will include 2 research participants with motor-complete SCI to evaluate the performance of the Medtronic epidural stimulator for restoring voluntary movement below the level of injury. Participants will be enrolled at CU Anschutz. Screening data will be reviewed to determine participant eligibility. Two participants who meet all inclusion criteria and none of the exclusion criteria will be entered into the study. The following treatment regimen will be used: epidural stimulation + 6 months of intensive outpatient physical therapy. Total duration of study participation will be 8 months.

Conditions

• Spinal Cord Injuries

Interventions

Type	Name	Description
DEVICE	implanted epidural stimulator	implantable multi-programmable neurostimulation system to deliver electrical stimulation to neural targets in the spinal cord

Timeline

• Start date: 2025-08-01
• Primary completion: 2026-01-01
• Completion: 2026-08-01
• First posted: 2023-08-01
• Last updated: 2025-04-03

Regulatory

• FDA-regulated device study