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SPARC Bladder Mapping and Training Study
Sponsor: University of Louisville
Summary
The investigators propose to determine the electrode configurations that promote functional gains in the storage and voiding phases of lower urinary tract function as a result of activation of spinal circuits with spinal cord epidural stimulation in humans with spinal cord injury. The innovative approach and novel application of the Medtronic Specify 5-6-5 (16-electrode array) epidural device will allow the investigators to determine, with this early feasibility study, specific parameters of spinal cord epidural stimulation and approaches for bladder training needed for lower urinary tract function which will lay the groundwork for expedient translation of this promising technology to larger numbers of individuals with spinal cord injury who currently have limited treatment options. The current proposed study will increase the understanding of human lumbosacral spinal networks and guide the use of innovative therapeutic strategies that would be immediately available to not only improve the motor output during standing and walking but also ameliorate bladder dysfunction and thus improve quality of life in individuals after spinal cord injury.
Official title: Functional Mapping With Lumbosacral Epidural Stimulation for Restoration of Bladder Function After Spinal Cord Injury: Simulation-Based Modeling and Interactive Programming Integration for Bladder Home-Training
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
10
Start Date
2018-09-12
Completion Date
2025-12-31
Last Updated
2024-12-13
Healthy Volunteers
No
Conditions
Interventions
Epidural Stimulation
Spinal cord epidural stimulation will be administered through a multi-electrode array implanted in the epidural space over the dorsum of the spinal cord. An implanted package containing stimulating circuits, rechargeable battery, and wireless communication activates the electrodes (16 platinum electrodes arranged in three columns of \[5-6-5\]). The pattern of electrically active electrodes, as well as electrode voltage, stimulating frequency, and stimulating pulse width will be varied to facilitate effects toward bladder function.
Locations (1)
University of Louisville
Louisville, Kentucky, United States