Blood Pressure Clinical Trial
Official title:
Effects of Activity-Dependent Plasticity on Recovery of Bladder and Sexual Function After Human Spinal Cord Injury
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.
Status | Recruiting |
Enrollment | 70 |
Est. completion date | January 3, 2027 |
Est. primary completion date | January 3, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility | Arm 1 Inclusion Criteria: - At least 18 years of age; - AIS A to D; - Neurogenic bladder and bowel dysfunction; - Stable medical condition Arm 2 Inclusion Criteria: - 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 Arms 1 and 2 Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Louisville | Louisville | Kentucky |
Lead Sponsor | Collaborator |
---|---|
University of Louisville | National Institutes of Health (NIH) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from baseline in systolic blood pressure over a 24 hour period after 80 sessions (6 months) | We will record systolic blood pressure every five minutes over a 24 hour period using a 24-hour blood pressure monitor | Baseline, 80 sessions (6 months) | |
Secondary | Change from baseline in bladder capacity after 80 sessions (6 months) | Using urodynamics we will measure bladder capacity in mL | Baseline, 80 sessions (6 months) | |
Secondary | Change from baseline in detrusor pressure after 80 sessions (6 months) | Using urodynamics we will measure detrusor pressure in cmH2O. | Baseline, 80 sessions (6 months) | |
Secondary | Change from baseline in mean resting anal pressure after 80 sessions (6 months) | Using anorectal manometry will will measure mean resting anal pressure in mmHg. | Baseline, 80 sessions (6 months) | |
Secondary | Change from baseline in mean squeeze pressure after 80 sessions (6 months) | Using anorectal manometry we will measure mean squeeze pressure in mmHg. | Baseline, 80 sessions (6 months) |
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---|---|---|---|
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