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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
Must not have
Untreated painful musculoskeletal dysfunction, fracture or pressure sore
Cardiovascular, respiratory, bladder, or renal disease unrelated to SCI
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 160 sessions (1 year)
Awards & highlights
No Placebo-Only Group

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.
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.
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 walk on my own without help.
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My spinal cord injury is not getting worse.
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I cannot walk on my own without help.
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It has been over 2 years since my injury.
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I cannot move all the joints in my legs on my own.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have untreated painful bone or muscle issues, fractures, or pressure sores.
Select...
I have heart, lung, bladder, or kidney conditions not caused by my spinal cord injury.
Select...
I rely on a machine to help me breathe.

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

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

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: 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
65 Previous Clinical Trials
99,549 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
~3 spots leftby Nov 2025
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