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Device
Spinal Cord Stimulation for Spinal Cord Injury
N/A
Waitlist Available
Led By Susan Harkema, PhD
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
inability to walk independently overground
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 160 sessions (1 year)
Awards & highlights
Study Summary
This trial will study the effects of electrical stimulation on the spinal cord in people with paralysis, in hopes of restoring some function.
Who is the study for?
This trial is for individuals with severe, non-progressive spinal cord injury (SCI) who are at least two years post-injury. Participants must be unable to walk independently or move all leg joints voluntarily and should have a stable medical condition. It's not suitable for those with untreated musculoskeletal issues, psychiatric disorders, ongoing drug abuse, unrelated cardiovascular diseases, or women who are or plan to become pregnant.Check my eligibility
What is being tested?
The study tests if activating spinal circuits using Epidural Stimulation (scES) can help people with SCI regain the ability to stand, step and move voluntarily. There will be specific scES configurations used during training sessions aimed at improving movement control as well as cardiovascular and respiratory functions.See study design
What are the potential side effects?
While the side effects aren't detailed in this summary, similar interventions may cause discomfort at the stimulation site, muscle spasms or changes in blood pressure. The impact on bladder and bowel function will also be monitored due to potential alterations caused by scES.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I cannot move all the joints in my legs on my own.
Select...
I cannot walk on my own without help.
Select...
My spinal cord injury is not getting worse.
Select...
I cannot walk on my own without help.
Select...
It has been over 2 years since my injury.
Select...
I cannot move all the joints in my legs on my own.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 160 sessions (1 year)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 160 sessions (1 year)
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 of lower extremity independence time during 10 min standing bout after 160 sessions (1 year)
Change from baseline of number of consecutive hip flexion repetitions performed within one minute after 160 sessions (1 year)
Change from baseline of stepping independence time during 6 min stepping bout after 160 sessions (1 year)
Secondary outcome measures
Change from baseline in bladder capacity after 160 sessions (1 year)
Change from baseline in bladder compliance after 160 sessions (1 year)
Change from baseline in bladder voiding efficiency after 160 sessions (1 year)
+12 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Stand, Step and Voluntary TrainingExperimental Treatment2 Interventions
Find a Location
Who is running the clinical trial?
Susan Harkema PhDLead Sponsor
1 Previous Clinical Trials
16 Total Patients Enrolled
The Leona M. and Harry B. Helmsley Charitable TrustOTHER
57 Previous Clinical Trials
93,902 Total Patients Enrolled
Susan HarkemaLead Sponsor
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I cannot move all the joints in my legs on my own.It has been over 2 years since my injury.I cannot walk on my own without help.My spinal cord injury is not getting worse.I have untreated painful bone or muscle issues, fractures, or pressure sores.I cannot walk on my own without help.I have heart, lung, bladder, or kidney conditions not caused by my spinal cord injury.I rely on a machine to help me breathe.You have a mental health condition that hasn't been treated, or you currently abuse drugs.My health condition is stable.It has been over 2 years since my injury.My health condition is stable.I cannot move all the joints in my legs on my own.Your spinal cord injury is not getting worse.
Research Study Groups:
This trial has the following groups:- Group 1: Stand, Step and Voluntary Training
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Spinal Cord Injury Patient Testimony for trial: Trial Name: NCT04123847 — N/A
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there available vacancies for candidates to join this clinical trial?
"According to the latest information on clinicaltrials.gov, this specific medical trial is no longer recruiting patients. Initially posted in November 2020 and last edited a few weeks ago, 353 other studies are presently searching for participants instead."
Answered by AI
What are the projected results of this experiment?
"This monitored clinical trial has the primary aim of observing the alteration in lower extremity autonomy during a 10 minute standing session after 160 sessions (1 year). Additionally, secondary objectives include tracking changes in maximum expiratory pressure (MEP) via Respiratory Motor Control Assessment (RMCA), bowel sensation evaluated with anorectal manometry measured in mL, and forced vital capacity (FVC) assessed by means of Respiratory Motor Control Analysis."
Answered by AI
Who else is applying?
What state do they live in?
California
Texas
Florida
Other
How old are they?
18 - 65
What site did they apply to?
University of Louisville
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
1
2
0
What questions have other patients asked about this trial?
How long does screeing take? How long do screening visits take? What is involved with the screening? I have relatives in the Louisville area, and would consider relocating; would that be necessary?
PatientReceived 2+ prior treatments
Why did patients apply to this trial?
I ve tried surgery but unable to walk or move. I hope this trial will help me.
PatientReceived 2+ prior treatments
I’ve seen the great results that e-stim has done for others. I see the great work this facility does, and feel confident in their ability to conduct safe trials. I deeply desire my mobility and independence and I believe I am a great candidate to demonstrate the effectiveness of his treatment.
PatientReceived 2+ prior treatments
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