Task-specific Epidural Stimulation Study

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

Interventions

DEVICE

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.

DEVICE

Long Term Epidural Stimulation for Cardiovascular Stability

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

DEVICE

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.

DEVICE

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.

DEVICE

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.

Sponsors & Collaborators

• Christopher Reeve Paralysis Foundation

  collaborator OTHER

• University of Louisville

  lead OTHER

Principal Investigators

• Susan J Harkema, PhD · University of Louisville

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-11-08

Primary Completion

2024-12-30

Completion

2024-12-30

FDA Device

Yes

Countries

• United States

Study Locations