Recruiting

Epidural Stimulation

Sponsor:

University of Louisville

Code:

NCT03364660

Conditions

Spinal Cord Injuries

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Acute epidural stimulation for cardiovascular stability

Long Term Epidural Stimulation for Cardiovascular Stability

Participants undergo approximately 4 months of epidural stimulation for voluntary movement.

Long Term Epidural Stimulation for Cardiovascular Stability plus Stand Training

Participants undergo approximately 4 months of epidural stimulation for voluntary movement plus stand training.

Study Details

Brief summary:

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

Study ID

NCT03364660

Start date

Nov 8, 2017

Status verified date

Aug, 2024

Completion date

Dec 30, 2024

Anticipated

Primary completion date

Dec 30, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion 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

Exclusion Criteria:

  • 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

Study Design

Enrollment

36 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

Acute epidural stimulation for cardiovascular stability

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

Participants undergo approximately 4 months of epidural stimulation for cardiovascular stability, daily.

Participants undergo approximately 4 months of epidural stimulation for voluntary movement.

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

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.

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.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Susan J Harkema, PhD

502-582-7443susan.harkema@louisville.edu

Manpreet A Chopra, BAMS

502-582-7443manpreet.chopra@louisville.edu

Locations

University of Louisville

Recruiting

Louisville, Kentucky, United States, 40202

Contacts

Susan Harkema, PhD

502-582-7443susan.harkema@louisville.edu

More Information

Sponsor

University of Louisville

Last update posted

Aug 28, 2024

Last verified

Aug, 2024

Keywords

  • Epidural Stimulation
  • Spinal Cord Injury
  • Task-Specific

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Louisville on 2024-08-28.