Epidural Stimulation to Restore Voluntary Movement Following Spinal Cord Injury
Enrolling by invitation · Not applicable
Conditions studied: Spinal Cord Injuries
In brief
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.
Key facts
- Study ID
- NCT05966896
- Run by
- University of Colorado, Denver
- People needed
- 2
- Starts
- 2026-04-22
- Expected to finish
- 2027-12-01
- Last updated by the study team
- 2026-06-08
Who can join
Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- American Spinal Injury Association Impairment Scale B spinal cord injury diagnosis
- Beyond 6 months of injury date
- Spinal cord injury at a level range of cervical 7 to thoracic 8 (C7-T8) with signs of upper motor neuron injury
- 18 years or older
- Height 5'1" to 6'3"
- Weight 250 lbs or less
- Sufficient upper extremity strength to manage a stability aide
- Magnetic resonance imaging evidence of spared spinal cord neural fibers
You may not qualify if…
- Claustrophobia and/or other contraindications to magnetic resonance imaging
- Unstable or symptomatic cardiorespiratory issues, in the opinion of the investigators
- Recent (within 3 months) history of fracture, contractures, pressure sore, deep vein thrombosis, urinary tract infection, or other infections that might interfere with interventions
- Contraindications to epidural stimulator implantation surgery
- Received botox injections into the lower extremities within the past 6 months
- Pregnancy
- Cauda Equina injury
- Any other neurological disorder besides spinal cord injury
Where it is running
- University of Colorado Anschutz — Aurora, Colorado, United States
Full record on ClinicalTrials.gov
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