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Neurostimulation Device

Spinal Cord Epidural Stimulation for Spinal Cord Injury

N/A

Recruiting

Led By Charles Hubscher, PhD

Research Sponsored by University of Louisville

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Arm 1: Neurogenic bladder and bowel dysfunction

Arm 2: Neurogenic bladder and bowel dysfunction

Must not have

Arms 1 and 2: Prior Botox injections of the bladder and/or bladder augmentation surgery

Arms 1 and 2: Colostomy bag

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 80 sessions (6 months)

Awards & highlights

No Placebo-Only Group

Summary

This trial will study how well a new treatment for autonomic dysreflexia works in people with spinal cord injuries.

Who is the study for?

This trial is for adults with spinal cord injuries who have issues with bladder and bowel control. Participants must use intermittent catheterization and not be pregnant, ventilator-dependent, or have a colostomy bag. They shouldn't have had certain bladder treatments like Botox injections or surgery.

What is being tested?

The study tests how well spinal cord epidural stimulation can manage high blood pressure and improve bladder and sexual function after injury. It involves controlled lab assessments and at-home monitoring to evaluate the therapy's effectiveness.

What are the potential side effects?

Potential side effects may include discomfort at the stimulation site, changes in blood pressure during stimulation, skin irritation from electrodes, headache, back pain, or unexpected impacts on bladder or bowel functions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have issues controlling my bladder and bowel due to nerve problems.

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I have issues controlling my bladder and bowel due to nerve problems.

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I am 18 years old or older.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have had Botox injections in my bladder or bladder surgery before.

Select...

I use a colostomy bag.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 80 sessions (6 months)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 80 sessions (6 months)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 80 sessions (6 months) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change from baseline in systolic blood pressure over a 24 hour period after 80 sessions (6 months)

Secondary study objectives

Change from baseline in bladder capacity after 80 sessions (6 months)

Change from baseline in detrusor pressure after 80 sessions (6 months)

Change from baseline in mean resting anal pressure after 80 sessions (6 months)

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Cardiovascular spinal cord epidural stimulationExperimental Treatment1 Intervention

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.

Group II: Measure symptomatic indices of autonomic dysreflexiaActive Control1 Intervention

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.

0 / 6Eligibility criteria met