SPARC Bladder Mapping and Training Study



Status:Not yet recruiting
Conditions:Hospital, Orthopedic
Therapuetic Areas:Orthopedics / Podiatry, Other
Healthy:No
Age Range:18 - Any
Updated:8/4/2018
Start Date:September 2018
End Date:August 2020
Contact:Susan Harkema, PhD
Email:susanharkema@kentuckyonehealth.org
Phone:502-581-8675

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Functional Mapping With Lumbosacral Epidural Stimulation for Restoration of Bladder Function After Spinal Cord Injury

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.

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.

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
We found this trial at
1
site
500 S Preston St
Louisville, Kentucky
(502) 852-5555
University of Louisville The University of Louisville is a state supported research university located in...
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mi
from
Louisville, KY
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