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Procedure

Epidural Stimulation + Training for Spinal Cord Injury (MC-PP-3 Trial)

N/A
Recruiting
Research Sponsored by Susan Harkema PhD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
unable to voluntarily move all individual joints of the legs
Must not have received botox injections in the prior six months
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 80 sessions, approximately 3 months
Awards & highlights

MC-PP-3 Trial Summary

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

Who is the study for?
This trial is for adults over 18 with a stable, non-progressive spinal cord injury (SCI) between T1 and T10. They must be within one year post-injury, unable to stand or walk independently, have bladder dysfunction due to SCI, and not on anti-spasticity meds or received botox in the last six months. Excluded are those ventilator-dependent, with untreated major health issues or psychiatric disorders/drug abuse.Check my eligibility
What is being tested?
The study tests if epidural stimulation can improve standing, walking, and bladder functions in people with acute SCI. Participants will undergo different training protocols: Bladder Capacity Training, Bladder Voiding Efficiency Training, Step Training or Stand Training alongside the epidural stimulation.See study design
What are the potential side effects?
While specific side effects aren't listed here for this intervention type; generally speaking such procedures may cause discomfort at the stimulation site, potential infection risk from surgery and possible nerve irritation.

MC-PP-3 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I cannot move all the joints in my legs on my own.
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I have not had any botox injections in the last six months.
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I have bladder problems due to a spinal cord injury.
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I am not taking any medication for muscle stiffness.
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I cannot move all the joints in my legs on my own.
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My spinal cord injury is between the T1 and T10 vertebrae.
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I cannot stand or walk on my own.
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I am not currently taking any medication for muscle stiffness.
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My spinal cord injury is not getting worse.
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I am 18 years old or older.
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My health condition is currently stable.

MC-PP-3 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~80 sessions, approximately 3 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 80 sessions, approximately 3 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
Ambulation
Bladder storage/voiding

MC-PP-3 Trial Design

2Treatment groups
Experimental Treatment
Group I: LocomotionExperimental Treatment2 Interventions
Participants will receive 160 locomotor training sessions with epidural stimulation. These sessions may occur once a day (stand and step will alternate days) or twice a day (stand and step on the same day) as recommended by the study physician. Participants will train 5 days per week and each session will last between 1 to 1.5 hours.
Group II: Bladder+LocomotionExperimental Treatment4 Interventions
Participants will receive 80 sessions of bladder training alone followed by 80 sessions of locomotor training sessions with epidural stimulation. They will be asked to continue with your bladder training once you start locomotor training. Locomotor Training sessions may occur once a day (stand and step will alternate days) or twice a day (stand and step on the same day) as recommended by the study physician. Participants will train 5 days per week and each session will last between 1 to 1.5 hours.

Find a Location

Who is running the clinical trial?

Susan Harkema PhDLead Sponsor
1 Previous Clinical Trials
16 Total Patients Enrolled
University of LouisvilleLead Sponsor
338 Previous Clinical Trials
75,968 Total Patients Enrolled
National Institute of Neurological Disorders and Stroke (NINDS)NIH
1,339 Previous Clinical Trials
649,374 Total Patients Enrolled

Media Library

Epidural stimulation + Bladder Capacity Training (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT04879862 — N/A
Spinal Cord Injury Research Study Groups: Locomotion, Bladder+Locomotion
Spinal Cord Injury Clinical Trial 2023: Epidural stimulation + Bladder Capacity Training Highlights & Side Effects. Trial Name: NCT04879862 — N/A
Epidural stimulation + Bladder Capacity Training (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04879862 — N/A
Spinal Cord Injury Patient Testimony for trial: Trial Name: NCT04879862 — N/A

Frequently Asked Questions

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

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

Who else is applying?

What state do they live in?
Illinois
Florida
How old are they?
18 - 65
What site did they apply to?
Kentucky Spinal Cord Injury Center - University of Louisville
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
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.
PatientReceived 1 prior treatment
~5 spots leftby Apr 2025