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Recovery of Cardiovascular Function With Epidural Stimulation After Human Spinal Cord Injury

NCT02037620 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2022-03-28

Study results available
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Summary

We propose to demonstrate that epidural stimulation (ES) can be used to recover significant levels of autonomic control of cardiovascular and respiratory function as well as the ability to voluntarily control leg movements below the injury level. This intervention would provide an immediate therapeutic alternative to individuals who now have no recourse for treatment.

Conditions

  • Spinal Cord Injury

Interventions

DEVICE

5-6-5 Specify electrode

DEVICE

Restore Advance Pulse Generator

Sponsors & Collaborators

  • University of Louisville

    lead OTHER

Principal Investigators

  • Susan J Harkema, PhD · University of Louisville

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-07-31
Primary Completion
2019-09-20
Completion
2019-09-20
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02037620 on ClinicalTrials.gov