Task-specific Epidural Stimulation Study

Description

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.

Conditions

Spinal Cord Injuries

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Study Overview

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Study Details

Study overview

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.

Task and Physiological Specific Stimulation for Recovery of Autonomic Function, Voluntary Movement, and Standing Using Epidural Stimulation and Training After Severe Spinal Cord Injury

Task-specific Epidural Stimulation Study

Condition
Spinal Cord Injuries
Intervention / Treatment

-

Contacts and Locations

Louisville

University of Louisville, Louisville, Kentucky, United States, 40202

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of Louisville,

Susan J Harkema, PhD, PRINCIPAL_INVESTIGATOR, University of Louisville

Study Record Dates

2024-12-30