SPARC Bladder Mapping and Training Study
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|ClinicalTrials.gov Identifier: NCT03452007|
Recruitment Status : Not yet recruiting
First Posted : March 2, 2018
Last Update Posted : August 2, 2018
|Condition or disease||Intervention/treatment||Phase|
|Spinal Cord Injuries||Device: Epidural Stimulation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||6 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Functional Mapping With Lumbosacral Epidural Stimulation for Restoration of Bladder Function After Spinal Cord Injury|
|Estimated Study Start Date :||September 2018|
|Estimated Primary Completion Date :||August 2020|
|Estimated Study Completion Date :||August 2020|
Experimental: Bladder Mapping and Training
Individuals already implanted with a spinal cord epidural stimulator will receive epidural stimulation targeted at enhancing both the storage and voiding phase of micturition cycle.
Device: 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.
- Improvements in bladder capacity as assessed by urodynamics [ Time Frame: 2 years ]The quantitative metric for capacity will be the percent change in either residual volume (measured in ml) alone if no leak occurred or residual volume plus leak volume if a reflex void occurred upon reaching capacity.
- Improvements in bladder pressure as assessed by urodynamics [ Time Frame: 2 years ]Percent change in maximum detrusor pressure (measured in cmH2O) will be recorded.
- Improvements in voiding efficiency as assessed by urodynamics [ Time Frame: 2 years ]The quantitative metric for voiding will be the percent change in efficiency (leak volume divided by leak plus residual volumes).
- Off-target effects of epidural stimulation [ Time Frame: 2 years ]These values will include measures of rectal pressure (% change in amplitude as measured in cmH2O from the abdominal pressure T-DOC air-charged catheter channel).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03452007
|Contact: Susan Harkema, PhDfirstname.lastname@example.org|
|Contact: Charles Hubscher, PhDemail@example.com|
|United States, Kentucky|
|University of Louisville|
|Louisville, Kentucky, United States, 40202|
|Principal Investigator:||Susan Harkema, PhD||University of Louisville|