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Search / Trial NCT02037620

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

Launched by UNIVERSITY OF LOUISVILLE · Jan 14, 2014

Trial Information

Current as of July 24, 2025

Completed

Keywords

Epidural Stimulation

ClinConnect Summary

We will enroll 4 research participants who have sustained a motor complete SCI to participate in the proposed experiments. Participants will be screened for eligibility, followed by 80 days of usual care, epidural implantation, 80 days of cardiovascular epidural stimulation training, 80 days of voluntary movement (VM) epidural stimulation training and finally 80 days of stand epidural stimulation training. These interventions are done in sequential order, however they are cumulative. In between each intervention, participants will undergo motor and cardiovascular experiments and assessments.

Gender

ALL

Eligibility criteria

  • 1. non-progressive SCI with complete motor paralysis above T1; American Spinal Injury Association Impairment Scale (AIS) A, B or C;
  • 2. 21 - 70 years of age;
  • 3. greater than 2 years post injury;
  • 4. stable medical condition;
  • 5. unable to voluntarily move all single joints of the legs;
  • 6. cardiovascular dysfunction including presence of persistent resting blood pressures and/or symptoms of autonomic dysreflexia and/or orthostatic hypotension; and
  • 7. respiratory dysfunction including at least 15% deficit in predicted pulmonary function outcomes;
  • Exclusion Criteria:
  • 1. ventilator dependent;
  • 2. painful musculoskeletal dysfunction, unhealed fracture, contracture, or pressure sore that might interfere with training;
  • 3. clinically significant depression or ongoing drug abuse;
  • 4. cardiovascular, respiratory, bladder, or renal disease unrelated to SCI;
  • 5. severe anemia (Hgb\<8 g/dl) or hypovelemia; and
  • 6. HIV or AIDS related illness.

About University Of Louisville

The University of Louisville is a distinguished academic institution known for its commitment to advancing medical research and clinical innovation. As a clinical trial sponsor, the university leverages its extensive resources and expertise to conduct pioneering studies that aim to improve patient outcomes and enhance healthcare practices. With a focus on interdisciplinary collaboration and community engagement, the University of Louisville fosters an environment conducive to groundbreaking research across various medical fields, ensuring adherence to the highest ethical standards and regulatory compliance. Through its clinical trials, the university seeks to translate scientific discoveries into tangible benefits for patients and the broader community.

Locations

Louisville, Kentucky, United States

Patients applied

0 patients applied

Trial Officials

Susan J Harkema, PhD

Principal Investigator

University of Louisville

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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