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Spinal Cord Stimulation

Epi Stim to Facilitate Standing and Stepping

N/A
Waitlist Available
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 160 session (1 year)
Awards & highlights
No Placebo-Only Group

Summary

The overall aim is to assess whether task specific locomotor training and spinal cord electrical stimulation (SCES) can induce neural reorganization of the functionally isolated human spinal cord to improve standing and stepping in individuals with functionally complete SCI. The investigators propose that locomotor training will result in generation of more effective standing and stepping efferent patterns by restoring phase dependent modulation of reflexes and reciprocal inhibition, reducing clonus and mediating interlimb coordination. The investigators propose that the SCES will optimize the physiological state of the spinal cord interneuronal circuitry compromised by compensating for loss of supraspinal input for the retraining of these tasks.

Eligible Conditions
  • Spinal Cord Injury

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 160 session (1 year)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 160 session (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
Lower Extremity
Change From Baseline of Stepping Independence Time During 6 Min Stepping Bout After 160 Sessions (1 Year)
Secondary study objectives
Change From Baseline of Number of Consecutive Hip Flexion Repetitions Performed Within One Minute After 160 Sessions (1 Year)

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: Epidural StimulatorExperimental Treatment1 Intervention
Eligible participants will be implanted with 16-electrode epidural array in the T11-L1 area of the spinal cord
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Standing and Stepping with spinal cord Epidural Stimulation
2010
N/A
~10

Find a Location

Who is running the clinical trial?

The Leona M. and Harry B. Helmsley Charitable TrustOTHER
65 Previous Clinical Trials
99,557 Total Patients Enrolled
National Institute for Biomedical Imaging and Bioengineering (NIBIB)NIH
94 Previous Clinical Trials
21,284 Total Patients Enrolled
University of LouisvilleLead Sponsor
348 Previous Clinical Trials
77,693 Total Patients Enrolled
University of California, Los AngelesOTHER
1,567 Previous Clinical Trials
10,312,180 Total Patients Enrolled
Christopher Reeve Paralysis FoundationOTHER
5 Previous Clinical Trials
1,787 Total Patients Enrolled
Kessler FoundationOTHER
184 Previous Clinical Trials
11,261 Total Patients Enrolled
Susan Harkema, PhDPrincipal InvestigatorUniversity of Louisville
3 Previous Clinical Trials
62 Total Patients Enrolled
~1 spots leftby Dec 2025
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