Epidural Stimulation for Spinal Cord Injury

This study is exploring how epidural stimulation (a device implanted in your spinal cord) can help people with severe spinal cord injuries. Researchers want to see if this stimulation can improve your body's automatic functions, like blood pressure (cardiovascular stability), help you move your legs voluntarily, and assist with standing. You might be eligible if you are at least 18 years old, have had a non-progressive spinal cord injury for at least two years, cannot move your legs or stand independently, and experience issues with your blood pressure. The study aims to understand how well epidural stimulation helps with cardiovascular function and voluntary movement, with results measured for up to 20 months. The current status of this study is unclear.

Study design
This interventional study plans to enroll 36 participants with severe spinal cord injuries. Participants will be randomized into different groups receiving various types of epidural stimulation, sometimes combined with stand training.
What's involved
You would have an epidural stimulator implanted. Depending on your assigned group, you would undergo approximately 4 months of daily epidural stimulation for cardiovascular stability, or 4-7 days weekly for voluntary movement, potentially combined with stand training.
Compensation
Not stated in the trial record.
Follow-up
Your cardiovascular function and voluntary movement will be assessed for up to 20 months after the intervention.

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NCT03364660

Task-specific Epidural Stimulation Study

Recruiting
NAAges 18+InterventionalTreatment
University of Louisville
~36 participants
Updated 2024-08-28 on ClinicalTrials.gov
What's tested:Acute epidural stimulation for cardiovascular stabilityLong Term Epidural Stimulation for Cardiovascular StabilityParticipants undergo approximately 4 months of epidural stimulation for voluntary movement.Long Term Epidural Stimulation for Cardiovascular Stability plus Stand TrainingParticipants undergo approximately 4 months of epidural stimulation for voluntary movement plus stand training.

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Recovery of autonomic control of cardiovascular function as assessed by cardiovascular assessments
Measured over up to 20 months
+1 more outcome measured
Spinal Cord Injuries
1 sites across 1 states
Kentucky1
  • Susan J Harkema, PhD · PRINCIPAL_INVESTIGATOR · University of Louisville

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Eligibility criteria

Inclusion

At least 18 years of age
Non-progressive spinal cord injury
At least 2 years post injury
Stable medical condition
Unable to voluntarily move all individual joints of the legs
Unable to stand independently
Cardiovascular dysfunction including presence of persistent low blood pressures 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
Urodynamic dysfunction including dyssynergia and/or inability to void voluntarily and/or low voiding capacity
Respiratory dysfunction including at least 15% deficit in predicted pulmonary function outcomes

Exclusion

Ventilator dependent
Untreated painful musculoskeletal dysfunction, fracture or pressure sore
Untreated psychiatric disorder or ongoing drug abuse
Cardiovascular, respiratory, bladder, or renal disease unrelated to spinal cord injury
Bladder botox injections less than 12 months prior to implant
Colostomy bag, urostomy
Any implanted pump (i.e., baclofen pump, pain pump, etc)
Ongoing nicotine use
Pregnant at the time of enrollment or planning to become pregnant during the time course of the study
  • Recovery of autonomic control of cardiovascular function as assessed by cardiovascular assessmentsup to 20 months
  • Recovery of voluntary movement as assessed by functional movement assessmentsup to 20 months