Epidural Stimulation for Spinal Cord Injury

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Spinal Cord InjuryEpidural Stimulation - Device
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial will study the effects of lumbosacral spinal cord epidural stimulation (scES) on individuals with severe spinal cord injury (SCI) who have cardiovascular and respiratory dysfunction and who are unable to voluntarily move the legs or stand.

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 0 Secondary · Reporting Duration: 20 months

20 months
Recovery of autonomic control of cardiovascular function as assessed by cardiovascular assessments
Recovery of voluntary movement as assessed by functional movement assessments

Trial Safety

Trial Design

4 Treatment Groups

Voluntary Movement ES + Stand Training
1 of 4
Voluntary Movement Epidural Stimulation
1 of 4
Cardiovascular ES + Stand Training
1 of 4
Cardiovascular Epidural Stimulation
1 of 4

Experimental Treatment

36 Total Participants · 4 Treatment Groups

Primary Treatment: Epidural Stimulation · No Placebo Group · N/A

Voluntary Movement ES + Stand TrainingExperimental Group · 2 Interventions: Epidural Stimulation, Stand Training · Intervention Types: Device, Biological
Voluntary Movement Epidural Stimulation
Device
Experimental Group · 1 Intervention: Epidural Stimulation · Intervention Types: Device
Cardiovascular ES + Stand TrainingExperimental Group · 2 Interventions: Epidural Stimulation, Stand Training · Intervention Types: Device, Biological
Cardiovascular Epidural Stimulation
Device
Experimental Group · 1 Intervention: Epidural Stimulation · Intervention Types: Device

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 20 months

Who is running the clinical trial?

Christopher Reeve Paralysis FoundationOTHER
5 Previous Clinical Trials
1,759 Total Patients Enrolled
University of LouisvilleLead Sponsor
314 Previous Clinical Trials
72,904 Total Patients Enrolled
Susan J Harkema, PhDPrincipal InvestigatorUniversity of Louisville
1 Previous Clinical Trials
5 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 9 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
At least 18 years old.
is needed to stabilize It takes at least 2 years after an injury for the body to stabilize and heal properly.
Non-progressive spinal cord injury is a term used to describe a spinal cord injury that does not worsen over time
You have a respiratory dysfunction including at least 15% deficit in predicted pulmonary function outcomes.
The patient has a stable medical condition.
, quadriplegics use assistive technology to move them
You are unable to stand independently.
You have persistent low blood pressure and/or symptoms of autonomic dysreflexia and/or orthostatic hypotension and/or dysregulation in response to postural changes and/or highly variable blood pressures in a 24 hour period.