Task-specific Epidural Stimulation Study

Part of paid clinical trials in Louisville, Kentucky.

Sponsor
University of Louisville
Study ID
NCT03364660
Status
Recruiting
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Conditions

  • Spinal Cord Injuries

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Acute epidural stimulation for cardiovascular stability — DEVICE
    Eligible participants will be implanted with 16-electrode epidural array and epidural stimulator in the spinal cord. Participants received mapping for cardiovascular stability.
  • Long Term Epidural Stimulation for Cardiovascular Stability — DEVICE
    Participants undergo approximately 4 months of epidural stimulation for cardiovascular stability, daily.
  • Participants undergo approximately 4 months of epidural stimulation for voluntary movement. — DEVICE
    Participants undergo approximately 4 months of epidural stimulation for voluntary movement 4-7 days weekly.
  • Long Term Epidural Stimulation for Cardiovascular Stability plus Stand Training — DEVICE
    Participants undergo approximately 4 months of epidural stimulation for cardiovascular stability, daily. Standing in a body weight support (BWS) harness on a treadmill or standing in a standing frame with epidural stimulation for standing up to 5 days weekly.
  • Participants undergo approximately 4 months of epidural stimulation for voluntary movement plus stand training. — DEVICE
    Participants undergo approximately 4 months of epidural stimulation for voluntary movement, 4-7 days weekly. Standing in a body weight support (BWS) harness on a treadmill or standing in a standing frame with epidural stimulation for standing up to 5 days weekly. Standing in a body weight support (BWS) harness on a treadmill or standing in a standing frame with epidural stimulation for standing up to 5 days weekly.

Study Details

The investigators propose to understand the role of lumbosacral spinal cord epidural stimulation (scES) in recovery of autonomic nervous system function, voluntary movement, and standing in individuals with severe spinal cord injury (SCI). Thirty-six individuals with severe SCI who have cardiovascular and respiratory dysfunction and who are unable to voluntarily move the legs or stand will receive scES for cardiovascular function, voluntary movement, or standing with and/or without weight-bearing standing. Training will consist of practicing voluntary movements or standing in the presence of specific scES configurations designed for the voluntary movements of the legs and trunk (Vol-scES), or epidural stimulation configurations specific for standing (Stand-scES). Specific configurations epidural stimulation for cardiovascular function (CV-scES) will be provided during sitting and supine and during maneuvers of orthostatic or cardiovascular stress. The ability to move voluntarily, stand, as well as cardiovascular, respiratory, bladder, bowel and sexual function will be assessed in these individuals with chronic severe spinal cord injury. Quality of life and costs of health care also will be assessed.

Key Dates

Start date
Nov 8, 2017
Status verified
Aug 2024
Primary completion
Dec 30, 2024
Completion
Dec 30, 2024

Study Design

Enrollment
36 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Acute Epidural Stimulation for Cardiovascular Stability.
    Participants are assessed both with and without epidural stimulation for cardiovascular stability for persistent hypotension, orthostatic hypotension and autonomic dysreflexia.
  • Experimental: Epidural Stimulation for Cardiovascular stability during daily activities
    Participants assigned to this arm will receive be randomized to receive epidural stimulation specific for cardiovascular function alone or cardiovascular function and standing, or voluntary movement alone or voluntary movement and standing.
  • Experimental: Voluntary Movement ES + Stand Training
    Participants assigned to this group will receive epidural stimulation specific for voluntary movement and will also receive stand training.
  • Experimental: Cardiovascular ES + Stand Training
    Participants assigned to this group will receive epidural stimulation specific for cardiovascular function and will also receive stand training.
  • Experimental: Epidural Stimulation for Voluntary Movement
    Participants assigned to this group receive epidural stimulation specifically for voluntary movement.

Primary Outcome Measure

Recovery of autonomic control of cardiovascular function as assessed by cardiovascular assessments [ Time Frame: up to 20 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of LouisvilleLouisvilleKentucky40202
Susan Harkema, PhD
[email protected]
502-582-7443

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University of Louisville· Louisville, KY

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