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OpenTrials
Completed

NCT Number: NCT02037620

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

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.

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Key information

Age range

21 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Louisville

Louisville, Kentucky, 40202, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • non-progressive SCI with complete motor paralysis above T1; American Spinal Injury Association Impairment Scale (AIS) A, B or C;
  • 21 - 70 years of age;
  • greater than 2 years post injury;
  • stable medical condition;
  • unable to voluntarily move all single joints of the legs;
  • cardiovascular dysfunction including presence of persistent resting blood pressures and/or symptoms of autonomic dysreflexia and/or orthostatic hypotension; and
  • respiratory dysfunction including at least 15% deficit in predicted pulmonary function outcomes;

Exclusion criteria

  • ventilator dependent;
  • painful musculoskeletal dysfunction, unhealed fracture, contracture, or pressure sore that might interfere with training;
  • clinically significant depression or ongoing drug abuse;
  • cardiovascular, respiratory, bladder, or renal disease unrelated to SCI;
  • severe anemia (Hgb<8 g/dl) or hypovelemia; and
  • HIV or AIDS related illness.

Treatment and study plan

5-6-5 Specify electrode

Device

Restore Advance Pulse Generator

Device

Primary outcomes

  1. Mean Arterial Blood Pressure in Response to Epidural Stimulation

    Time frame: 20 months

    Noninvasive continuous blood pressure measured from a finger cuff by plethysmographic technique (Finometer Pro, FMS, Amsterdam, Netherlands) was calibrated to brachial blood pressure. Mean arterial pressure was calculated as one-third of systolic blood pressure plus two-third of diastolic blood pressure.

Sponsors and collaborators

Lead sponsor

University of Louisville

Other

Registry information

Important dates

Study start
2014
Primary completion
2019
Study completion
2019
First posted
Jan 16, 2014
Registry last updated
Mar 28, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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