SPARC Bladder Mapping and Training Study
Primary Purpose
Spinal Cord Injuries
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Epidural Stimulation
Sponsored by
About this trial
This is an interventional treatment trial for Spinal Cord Injuries focused on measuring Epidural Stimulation, Bladder dysfunction, Spinal cord injury
Eligibility Criteria
Inclusion Criteria:
- 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;
Exclusion Criteria:
- 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.
Sites / Locations
- University of LouisvilleRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Bladder Mapping and Training
Arm Description
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.
Outcomes
Primary Outcome Measures
Changes in bladder capacity as assessed by urodynamics
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
Percent change in maximum detrusor pressure (measured in cmH2O) will be recorded.
Changes in voiding efficiency as assessed by urodynamics
The quantitative metric for voiding will be the percent change in efficiency (leak volume divided by leak plus residual volumes).
Secondary Outcome Measures
Changes in rectal squeeze pressure
Percent change in amplitude as measured in cmH2O
Changes in gastrointestinal motility
Percent change in gut transit time as measured in hours.
Full Information
NCT ID
NCT03452007
First Posted
February 25, 2018
Last Updated
April 26, 2022
Sponsor
University of Louisville
1. Study Identification
Unique Protocol Identification Number
NCT03452007
Brief Title
SPARC Bladder Mapping and Training Study
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 12, 2018 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Louisville
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes
5. Study Description
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 (anode/cathode 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injuries
Keywords
Epidural Stimulation, Bladder dysfunction, Spinal cord injury
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Bladder Mapping and Training
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Epidural Stimulation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes in bladder capacity as assessed by urodynamics
Description
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.
Time Frame
2 years
Title
Changes in bladder pressure as assessed by urodynamics
Description
Percent change in maximum detrusor pressure (measured in cmH2O) will be recorded.
Time Frame
2 years
Title
Changes in voiding efficiency as assessed by urodynamics
Description
The quantitative metric for voiding will be the percent change in efficiency (leak volume divided by leak plus residual volumes).
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Changes in rectal squeeze pressure
Description
Percent change in amplitude as measured in cmH2O
Time Frame
2 years
Title
Changes in gastrointestinal motility
Description
Percent change in gut transit time as measured in hours.
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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;
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Susan Harkema, PhD
Phone
502-581-8675
Email
susan.harkema@louisville.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Charles Hubscher, PhD
Phone
502-852-3058
Email
charles.hubscher@louisville.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susan Harkema, PhD
Organizational Affiliation
University of Louisville
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Louisville
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Susan Harkema, PhD
Phone
502-581-8675
Email
susan.harkema@louisville.edu
12. IPD Sharing Statement
Plan to Share IPD
No
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SPARC Bladder Mapping and Training Study
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