Epidural Stimulation for Spinal Cord Injury

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
University of Louisville, Louisville, KYSpinal Cord InjuryEpidural Stimulation - Device
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial will help researchers determine the best way to use electrical stimulation of the spinal cord to improve bladder function in people with spinal cord injuries.

Treatment Effectiveness

Study Objectives

3 Primary · 2 Secondary · Reporting Duration: 2 years

2 years
Changes in bladder capacity as assessed by urodynamics
Changes in bladder pressure as assessed by urodynamics
Changes in gastrointestinal motility
Changes in rectal squeeze pressure
Changes in voiding efficiency as assessed by urodynamics

Trial Safety

Trial Design

1 Treatment Group

Bladder Mapping and Training
1 of 1

Experimental Treatment

10 Total Participants · 1 Treatment Group

Primary Treatment: Epidural Stimulation · No Placebo Group · N/A

Bladder Mapping and Training
Device
Experimental Group · 1 Intervention: Epidural Stimulation · Intervention Types: Device

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 2 years

Who is running the clinical trial?

University of LouisvilleLead Sponsor
316 Previous Clinical Trials
73,205 Total Patients Enrolled
Susan Harkema, PhDPrincipal InvestigatorUniversity of Louisville
3 Previous Clinical Trials
60 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 5 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have had a spinal cord injury for at least 2 years.
You have a device called a spinal cord epidural stimulator implanted in your body.
You have a spinal cord injury above your hips that is not getting worse, and you have limited control over your bladder. Your injury is classified as AIS A or B.

Frequently Asked Questions

What is the current recruitment capacity for this experimental program?

"Affirmative. Clinicaltrials.gov's data suggests that this clinical trial is actively seeking participants, with its original posting date being September 12th 2018 and last edited on April 26th 2022. The study needs to enroll 10 individuals from a single medical centre." - Anonymous Online Contributor

Unverified Answer

Is this research recruiting participants at the present time?

"At present, this medical trial is open to enrollment. It was initially announced on September 12th 2018 and the associated clinicaltrials.gov page has been updated most recently on April 26th 2022." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.