Status:
NOT_YET_RECRUITING
Epidural Stimulation to Restore Voluntary Movement Following Spinal Cord Injury
Lead Sponsor:
University of Colorado, Denver
Collaborating Sponsors:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Spinal Cord Injuries
Eligibility:
All Genders
18-100 years
Phase:
NA
Brief 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 su...
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 part...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
August 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2026
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT05966896
Start Date
August 1 2025
End Date
August 1 2026
Last Update
April 3 2025
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