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Device

Epidural Stimulation for Spinal Cord Injury

N/A

Recruiting

Led By Susan Harkema, 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

Stable medical condition without cardiopulmonary disease or dysautonomia that would contraindicate bladder training

AIS classification A or B

Must not have

Continent diversion procedures with or without bladder augmentation

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

No Placebo-Only Group

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.

Who is the study for?

This trial is for individuals with stable spinal cord injuries (SCI) who are at least two years post-injury, have an implanted epidural stimulator, and show signs of recovery from spinal shock. It's not suitable for those with certain medical conditions, ongoing drug abuse, recent bladder treatments like Botox injections or surgeries that change the way urine leaves the body.

What is being tested?

The study tests how different settings on a 16-electrode epidural device affect bladder control in people with SCI. The goal is to find out which settings improve bladder function during storage and voiding by activating specific spinal circuits.

What are the potential side effects?

While the description doesn't specify side effects, generally epidural stimulation can cause discomfort at the stimulation site, potential skin irritation from electrodes, or changes in blood pressure.

Eligibility Criteria

Inclusion Criteria

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

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My heart and lung health allows me to undergo bladder training.

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My spinal cord injury is classified as complete or sensory incomplete.

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My spinal shock has ended, shown by muscle tone or reflexes, and I've finished standard rehab.

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It has been over 2 years since my spinal cord injury.

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My spinal cord injury is above the sacrum and not worsening.

Exclusion Criteria

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

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I have had surgery to redirect urine flow with or without bladder enlargement.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Changes in bladder volume during filling cystometry at low filling pressures

Secondary study objectives

Changes in Bowel Function

Changes in Sexual Function

Changes in Systolic Blood Pressure

Other study objectives

Changes in Renal Bladder Ultrasound

Awards & Highlights

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: Bladder Mapping and TrainingExperimental Treatment1 Intervention

Individuals already implanted or newly implanted with a spinal cord epidural stimulator will receive epidural stimulation targeted at enhancing both the storage and voiding phase of micturition cycle.

0 / 6Eligibility criteria met