Last reviewed · How we verify

NCT03452007

SPARC Bladder Mapping and Training Study

Active, enrolled NA Last updated 13 December 2024
What this trial tests

NA trial testing Epidural Stimulation in Spinal Cord Injuries in 10 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline
12 September 2018
Primary endpoint
31 August 2024
31 December 2025

Quick facts

Lead sponsorUniversity of Louisville
PhaseNA
StatusActive, enrolled
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment10
Start date12 September 2018
Primary completion31 August 2024
Estimated completion31 December 2025
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

University of Louisville

Who can join

18 and older, any sex, with Spinal Cord Injuries. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Targeting bladder function with network-specific epidural stimulation after chronic spinal cord injury.
    Herrity AN, Aslan SC, Mesbah S, Siu R, et al · · 2022 · cited 22× · PMID 35778466 · DOI 10.1038/s41598-022-15315-2

Verify or expand the search:

Other trials of Epidural Stimulation

Trials testing the same drug.

Other recruiting trials for Spinal Cord Injuries

Currently open trials in the same condition.

Other University of Louisville trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03452007.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing