Ignite Creation Date:
2024-05-06 @ 11:12 AM
Last Modification Date:
2024-10-26 @ 12:41 PM
Study NCT ID:
NCT03452007
Status:
RECRUITING
Last Update Posted:
2024-04-25
First Post:
2018-02-25
Brief Title:
SPARC Bladder Mapping and Training Study
Sponsor:
University of Louisville
Organization:
University of Louisville
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
Deficits in urologic function after spinal cord injury impact quality of life and consistently ranks as a top priority issue in the spinal cord injury population Bladder dysfunction may manifest as detrusor hyperreflexia bladder contractions at low volumes causing incontinence and smooth muscle hypertrophy detrusor-sphincter dyssynergia uncoordinated bladder and external urethral sphincter contractions causing inefficient emptying and smooth muscle hypertrophy decreased compliance unable to store urine under appropriately low pressures and loss of continence requiring lifelong management maintenance and health care visits Current therapeutic approaches aim to manage both the storage and voiding phases of bladder function and include intermittent catheterization pharmacologic and surgical interventions While most of these strategies are necessary for urological maintenance post-injury they oftentimes are associated with side effects and therefore remain inadequate Therapies addressing recovery of function are still needed The use of spinal cord epidural stimulation is a promising alternative approach to addressing the primary phases of bladder dysfunction Additionally the effects of spinal cord epidural stimulation on bladder alone is not known as its use has been directed towards the locomotor system Thus the overall objective of this study is to perform functional mapping in order to identify the spinal cord epidural stimulation configurations anodecathode selection amplitude frequency and pulse width at the lumbosacral level that can promote neural control of bladder storage capacity and bladder emptying voiding efficiency after spinal cord injury
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1R01HL150581-01A1 | NIH | None | httpsreporternihgovquickSearch1R01HL150581-01A1 |
| 1UH3NS116238-01 | NIH | None | None |
| 3OT2OD024898-01S5 | NIH | None | None |