SPARC Bladder Mapping and Training Study

NCT03452007 | Active Not Recruiting DMC FDA Device

• 4 other identifiers: 17.10241UH3NS116238-013OT2OD024898-01S51R01HL150581-01A1
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Cord Injuries

Keywords

Epidural Stimulation; Bladder dysfunction; Spinal cord injury

Outcome Measures

Primary Outcomes (1)

• 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.

  2 years

Secondary Outcomes (3)

• Changes in Sexual Function

  2 years

• Changes in Bowel Function

  2 years

• Changes in Systolic Blood Pressure

  2 years

Other Outcomes (1)

• Changes in Renal Bladder Ultrasound

  2 years

Study Arms (1)

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.

Device: Epidural Stimulation

Interventions

Epidural Stimulation DEVICE

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.

Bladder Mapping and Training

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Louisville: lead
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator
• National Institutes of Health (NIH): collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

University of Louisville

Louisville, Kentucky, 40202, United States

Location

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Susan Harkema, PhD

  University of Louisville

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 25, 2018
• First Posted: March 2, 2018
• Study Start: September 12, 2018
• Primary Completion: August 31, 2024
• Study Completion: December 31, 2025
• Last Updated: December 13, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)