RecruitingNot ApplicableNCT04193709

Recovery of Bladder and Sexual Function After Human Spinal Cord Injury

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

Sponsor

University of Louisville

Enrollment

70 participants

Start Date

Jan 4, 2021

Study Type

INTERVENTIONAL

Conditions

Blood Pressure Autonomic Dysreflexia Urinary Bladder, Neurogenic

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

Min Age: 18 YearsMax Age: 70 Years

Inclusion Criteria9

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

Exclusion Criteria5

Prior Botox injections of the bladder and/or bladder augmentation surgery;
Colostomy bag,
Ventilator dependent;
Any implanted pump (i.e. Baclofen pump, pain pump, etc.);
Pregnant at the time of enrollment or planning to become pregnant during the time course of the study

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Interventions

DEVICESpinal Cord Epidural Stimulation

For arm 2, optimal stimulation parameters (cathode/anode configuration, stimulation frequency and voltage; placement of electrode from L1 to S1) will be identified for blood pressure and bladder pressure to achieve a bladder capacity in the target normative range of 400-450 mLs. Spinal cord epidural stimulation will then be used in a controlled lab setting for the regulation of blood pressure and heart rate to maintain normative values (target systolic pressure of 110-120 mmHg) and bladder pressure below 10 cmH2O during bladder filling up to the targeted capacity (fill volume of 400 mLs).