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RECRUITING
NCT03364660
NA

Task-specific Epidural Stimulation Study

Sponsor: University of Louisville

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

36

Start Date

2017-11-08

Completion Date

2024-12-30

Last Updated

2024-08-28

Healthy Volunteers

No

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.

Locations (1)

University of Louisville

Louisville, Kentucky, United States