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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
Unable to voluntarily move all individual joints of the legs
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 below
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I cannot move all the joints in my legs on my own.
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I cannot move all the joints in my legs on my own.
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I cannot walk on my own without help.
Select...
My spinal cord injury is not getting worse.
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I cannot walk on my own without help.
Select...
I cannot walk on my own without help.
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My health condition is stable.
Select...
It has been over 2 years since my injury.
Select...
My spinal cord injury is not getting worse.
Select...
I cannot move all the joints in my legs on my own.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 160 sessions (1 year)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 160 sessions (1 year) for reporting.

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 more

Trial 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
56 Previous Clinical Trials
93,710 Total Patients Enrolled
Susan HarkemaLead Sponsor

Media Library

Standing, Stepping and Voluntary Movement with spinal cord Epidural Stimulation (Device) Clinical Trial Eligibility Overview. Trial Name: NCT04123847 — N/A
Spinal Cord Injury Research Study Groups: Stand, Step and Voluntary Training
Spinal Cord Injury Clinical Trial 2023: Standing, Stepping and Voluntary Movement with spinal cord Epidural Stimulation Highlights & Side Effects. Trial Name: NCT04123847 — N/A
Standing, Stepping and Voluntary Movement with spinal cord Epidural Stimulation (Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04123847 — N/A
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
~2 spots leftby Nov 2024