Status:
ENROLLING_BY_INVITATION
Neuromodulation of Spinal Locomotor Circuitry to Elicit Stepping After Pediatric Spinal Cord Injury
Lead Sponsor:
University of Louisville
Collaborating Sponsors:
Kentucky Spinal Cord and Head Injury Research Trust and Board
Kosair Charities, Inc.
Conditions:
Spinal Cord Injuries
Eligibility:
All Genders
4-12 years
Phase:
NA
Brief Summary
Spinal cord injury (SCI) results in damage to the descending neural pathways and leads to the immediate dysfunction of multiple physiological systems below the level of injury. Like adults, children w...
Detailed Description
Like in adults, children with spinal cord injury (SCI) in children suffer from neuromuscular paralysis which results in the inability to sit, stand, and walk. Current therapeutic interventions, e.g. l...
Eligibility Criteria
Inclusion
- Children with acquired, upper motor neuron (T10 and above) SCI, traumatic and non-traumatic,
- Chronic injury, defined as greater than one year post injury
- Age 4-12 years,
- Discharged from inpatient rehabilitation,
- Unable to stand, walk, or initiate steps.
Exclusion
- Botox use within past 3 months
- Current oral baclofen use,
- Baclofen pump in use,
- Musculoskeletal impairment limiting range of motion, unhealed fracture or other medical complication limiting participation,
- Prior surgery for scoliosis, post SCI
- Congenital SCI,
- Total ventilator dependence.
- For Aim 3, additional exclusionary criteria are:
- Unwilling or unable to wean from baclofen during training,
- Use of braces (trunk or lower limb brace).
Key Trial Info
Start Date :
April 12 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2026
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT04077346
Start Date
April 12 2021
End Date
January 1 2026
Last Update
February 26 2025
Active Locations (1)
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1
Department of Neurosurgery, University of Louisville
Louisville, Kentucky, United States, 40202