Epidural stimulation + Bladder Capacity Training for Spinal Cord Injury

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Kentucky Spinal Cord Injury Center - University of Louisville, Louisville, KYSpinal Cord InjuryEpidural stimulation + Bladder Capacity Training - CombinationProduct
Eligibility
18 - 65
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing whether epidural stimulation can help people with spinal cord injuries walk and improve their bladder function.

Eligible Conditions
  • Spinal Cord Injury

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 0 Secondary · Reporting Duration: 80 sessions, approximately 3 months

Month 3
Ambulation
Bladder storage/voiding

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

Locomotion
1 of 2
Bladder+Locomotion
1 of 2

Experimental Treatment

16 Total Participants · 2 Treatment Groups

Primary Treatment: Epidural stimulation + Bladder Capacity Training · No Placebo Group · N/A

LocomotionExperimental Group · 2 Interventions: Epidural stimulation + Stand Training, Epidural stimulation + Step Training · Intervention Types: CombinationProduct, CombinationProduct
Bladder+LocomotionExperimental Group · 4 Interventions: Epidural stimulation + Stand Training, Epidural stimulation + Bladder Capacity Training, Epidural stimulation + Bladder Voiding Efficiency Training, Epidural stimulation + Step Training · Intervention Types: CombinationProduct, CombinationProduct, CombinationProduct, CombinationProduct

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 80 sessions, approximately 3 months

Who is running the clinical trial?

University of LouisvilleLead Sponsor
316 Previous Clinical Trials
73,199 Total Patients Enrolled
National Institute of Neurological Disorders and Stroke (NINDS)NIH
1,270 Previous Clinical Trials
456,086 Total Patients Enrolled

Eligibility Criteria

Age 18 - 65 · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Your spinal cord injury is not getting worse.
You are not taking any medication to treat muscle stiffness or spasms.
You cannot have had botox injections in the last six months.
You are in good health and your medical condition is not changing quickly.
You are not able to stand or walk without assistance.
You cannot move all the joints in your legs on your own.
You have bladder problems due to a spinal cord injury.
You have a spinal cord injury between the first and tenth thoracic vertebrae.

Who else is applying?

What state do they live in?
Illinois50.0%
Florida50.0%
How old are they?
18 - 65100.0%
What site did they apply to?
Kentucky Spinal Cord Injury Center - University of Louisville100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%
Why did patients apply to this trial?
  • "I have a c-5 injury and I am just starting to move my lower leg muscles"
How many prior treatments have patients received?
0100.0%

Frequently Asked Questions

How many participants are actively engaged in this research project?

"Affirmative. The clinicaltrials.gov website shows that this medical experiment, which was initially posted on April 4th 2022, is actively looking for volunteers. Approximately 16 individuals are required to be recruited from a single site." - Anonymous Online Contributor

Unverified Answer

What are the criteria for eligibility to participate in this research?

"This medical trial is in need of 16 volunteers between the ages 18-65 who have experienced a spinal cord injury. To qualify, applicants must meet all the following criteria: be aged at least 18 years old; possess an unchanging SCI status; maintain stable health condition; lack independent standing or stepping capability; unable to move lower leg joints voluntarily; no current anti-spasticity medication regimen within the past six months; bladder dysfunction as a consequence of their SCI diagnosis; level of affliction should lie between T1 and T10 on vertebral column scale, with less than one year elapsed since initial onset." - Anonymous Online Contributor

Unverified Answer

Are there any slots left for participation in this clinical experiment?

"Affirmative. According to information present on clinicaltrials.gov, the investigation initially went live on April 4th 2022 and is currently looking for 16 participants from one medical facility." - Anonymous Online Contributor

Unverified Answer

Is this study open to participants aged 75 and older?

"In order to be accepted in this clinical study, prospective participants must have reached the age of majority and not exceed 65 years old." - 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.