Spinal Cord InjuriesNCT03452007
SPARC Bladder Mapping and Training Study
A study testing Epidural Stimulation in people with Spinal Cord Injuries, run by University of Louisville at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Injuries
- What is being tested?
- Epidural Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Sep 2018to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Louisville
Louisville, Kentucky, 40202
About this 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
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.
Read the 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.
- Conditions
- Spinal Cord Injuries
- Being tested
- Epidural Stimulation
- Keywords
- Epidural Stimulation, Bladder dysfunction, Spinal cord injury
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epidural StimulationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Bladder Mapping and Training | Experimental | Individuals already implanted or newly implanted with a spinal cord epidural stimulator will receive epidural stimulation targeted at enhancing both the storage and voiding phase of micturition cycle. Receives: Device: Epidural Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in bladder volume during filling cystometry at low filling pressures
The quantitative metric will be the percent changes in either residual volume (measured in ml) alone if no leak occurred or leak volume divided by leak plus residual volumes if a void occurred upon reaching capacity.
Measured: 2 years
Secondary outcomes (3)
Changes in Sexual Function
International SCI Data Set Questionnaire for Sexual Function
Measured: 2 years
Changes in Bowel Function
International SCI Data Set Questionnaire for Bowel Function
Measured: 2 years
Changes in Systolic Blood Pressure
Percent change without versus with epidural stimulation
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2018
- Study start12 Sep 2018
- Primary completion31 Aug 2024
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Louisville
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Susan Harkema PhD, University of Louisville
- Investigators
- Susan Harkema, PhD, Principal investigator, University of Louisville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03452007
- Sponsor's protocol ID
- 17.1024
- Other IDs
- 1UH3NS116238-01, 3OT2OD024898-01S5, 1R01HL150581-01A1
- Status last verified
- Dec 2024
- First submitted
- 25 Feb 2018
- Last updated
- 13 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03452007
- Acronym / sponsor ID
- 17.1024
- Conditions
- Spinal Cord Injuries
- Keywords
- Epidural Stimulation, Bladder dysfunction, Spinal cord injury
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of LouisvilleUniversity, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 12 Sep 2018 (actual)
- Primary completion
- 31 Aug 2024 (actual)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 2 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bladder Mapping and Training | Experimental | Device: Epidural StimulationIndividuals already implanted or newly implanted with a spinal cord epidural stimulator will receive epidural stimulation targeted at enhancing both the storage and voiding phase of micturition cycle. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Epidural StimulationSpinal 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. | Device | Bladder Mapping and Training |
Primary outcome
Changes in bladder volume during filling cystometry at low filling pressures
Time frame: 2 years
The quantitative metric will be the percent changes in either residual volume (measured in ml) alone if no leak occurred or leak volume divided by leak plus residual volumes if a void occurred upon reaching capacity.
3 secondary outcomes
Changes in Sexual Function
Time frame: 2 years
Changes in Bowel Function
Time frame: 2 years
Changes in Systolic Blood Pressure
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susan Harkema, PhD principal investigator
University of Louisville
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Epidural Stimulation in people with Spinal Cord Injuries, run by University of Louisville at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 13 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in bladder volume during filling cystometry at low filling pressures (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2024.