SPARC Bladder Mapping and Training Study
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|ClinicalTrials.gov Identifier: NCT03452007|
Recruitment Status : Recruiting
First Posted : March 2, 2018
Last Update Posted : May 3, 2022
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|Condition or disease||Intervention/treatment||Phase|
|Spinal Cord Injuries||Device: Epidural Stimulation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 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: Simulation-Based Modeling and Interactive Programming Integration for Bladder Home-Training|
|Actual Study Start Date :||September 12, 2018|
|Estimated Primary Completion Date :||December 2023|
|Estimated Study Completion Date :||December 2023|
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.
- Changes 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.
- Changes in bladder pressure as assessed by urodynamics [ Time Frame: 2 years ]Percent change in maximum detrusor pressure (measured in cmH2O) will be recorded.
- Changes 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).
- Changes in rectal squeeze pressure [ Time Frame: 2 years ]Percent change in amplitude as measured in cmH2O
- Changes in gastrointestinal motility [ Time Frame: 2 years ]Percent change in gut transit time as measured in hours.
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Implanted with spinal cord epidural stimulator
- stable medical condition without cardiopulmonary disease or dysautonomia that would contraindicate bladder training;
- clear indications that the period of spinal shock is concluded determined by presence of muscle tone, deep tendon reflexes or muscle spasms and discharged from standard inpatient rehabilitation;
- non-progressive supra-sacral SCI (i.e., upper motor neuron re bladder circuitry); - AIS classification A or B;
- at least 2 years post spinal cord injury;
- Painful musculoskeletal dysfunction, unhealed fracture, contracture, pressure sore or urinary tract infection that might interfere with mapping/training;
- Clinically significant depression or ongoing drug abuse;
- Pregnant at the time of enrollment or planning to become pregnant during the time course of the study
- Bladder Botox injections within the past year;
- Continent diversion procedures with or without bladder augmentation.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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||Recruiting|
|Louisville, Kentucky, United States, 40202|
|Contact: Susan Harkema, PhD 502-581-8675 firstname.lastname@example.org|
|Principal Investigator:||Susan Harkema, PhD||University of Louisville|
Documents provided by Susan Harkema, University of Louisville:
|Responsible Party:||Susan Harkema, Professor, University of Louisville|
|Other Study ID Numbers:||
|First Posted:||March 2, 2018 Key Record Dates|
|Last Update Posted:||May 3, 2022|
|Last Verified:||April 2022|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||Yes|
Spinal cord injury
Spinal Cord Injuries
Wounds and Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System