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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 80 sessions (6 months)

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

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

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 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of LouisvilleLead Sponsor

338 Previous Clinical Trials

75,914 Total Patients Enrolled

National Institutes of Health (NIH)NIH

2,697 Previous Clinical Trials

6,952,744 Total Patients Enrolled

Charles Hubscher, PhDPrincipal Investigator - University of Louisville

University of Louisville

1 Previous Clinical Trials

6 Total Patients Enrolled

Media Library

Spinal Cord Epidural Stimulation (Neurostimulation Device) Clinical Trial Eligibility Overview. Trial Name: NCT04193709 — N/A

Bowel Incontinence Research Study Groups: Measure symptomatic indices of autonomic dysreflexia, Cardiovascular spinal cord epidural stimulation

Bowel Incontinence Clinical Trial 2023: Spinal Cord Epidural Stimulation Highlights & Side Effects. Trial Name: NCT04193709 — N/A

Spinal Cord Epidural Stimulation (Neurostimulation Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04193709 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this experiment require any additional participants?

"According to clinicaltrials.gov, this study is in the process of recruiting suitable participants. It was initially put online on April 1st 2021 and has been recently updated as of June 5th 2022."

Answered by AI

How can I become a participant in this research effort?

"In order to join this medical trial, applicants must suffer from urinary bladder or neurogenic disorders and be aged between 18-70. This study is currently recruiting around 70 individuals."

Answered by AI

Is this clinical trial open to people younger than seventy years old?

"Patients aged 18 or older but younger than 70 are eligible to participate in this research."

Answered by AI

How many participants are in the sample group for this experiment?

"Indeed, according to information available on clinicaltrials.gov, this medical study is actively recruiting patients since its inception on April 1st 2021. 70 participants are required from a single centre for the trial's completion and the data was last updated on 6th May 2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Recovery of Bladder and Sexual Function After Human Spinal Cord Injury

Charles Hubscher 2021. "Recovery of Bladder and Sexual Function After Human Spinal Cord Injury". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04193709.

All > Spinal Cord