Effects of Activity-Dependent Plasticity on Recovery of Bladder and Sexual Function After Human Spinal Cord Injury

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

This study will incorporate critical cross viscero-visceral intersystem interactions to 1) investigate in a controlled laboratory setting and then with mobile at-home monitoring the extent, severity, and frequency of occurrence of autonomic dysreflexia with respect to daily bladder and bowel function, in conjunction with identifying potential underlying mechanisms by examining urinary biomarkers for several specific vasoactive hormones, and 2) to regulate cardiovascular function therapeutically as part of bladder and bowel management using spinal cord epidural stimulation.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• At least 18 years of age;

• AIS A to D;

• Neurogenic bladder and bowel dysfunction;

• Stable medical condition

• At least 18 years of age;

• AIS A to D;

• Neurogenic bladder and bowel dysfunction;

• Use of intermittent catheterization for bladder emptying;

• Prior implantation of a Medtronic scES array

Locations
United States
Kentucky
University of Louisville
RECRUITING
Louisville
Contact Information
Primary
Charles Hubscher, PhD
charles.hubscher@louisville.edu
502-852-3058
Time Frame
Start Date: 2021-01-04
Estimated Completion Date: 2027-01-03
Participants
Target number of participants: 70
Treatments
No_intervention: Measure symptomatic indices of autonomic dysreflexia
The purpose of this arm is to systematically measure symptomatic indices of autonomic nervous system activation and corresponding cardiovascular changes in persons with spinal cord injuries during bladder filling and bowel stimulation.
Experimental: Cardiovascular spinal cord epidural stimulation
The purpose of this arm is to use spinal cord epidural stimulation for maintenance of blood pressure and heart rate in the lab during cystometry (bladder filling) and anorectal filling (bowel distension) and in the at-home setting for maintenance of normative blood pressure and heart rate that can be triggered from bladder filling and during bowel evacuation.
Sponsors
Leads: University of Louisville
Collaborators: National Institutes of Health (NIH)

This content was sourced from clinicaltrials.gov