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Trial record 39 of 3478 for:    Louisville

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

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ClinicalTrials.gov Identifier: NCT02037620
Recruitment Status : Active, not recruiting
First Posted : January 16, 2014
Last Update Posted : February 28, 2018
Sponsor:
Information provided by (Responsible Party):
Susan Harkema, University of Louisville

Brief 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.

Condition or disease Intervention/treatment Phase
Spinal Cord Injury Device: 5-6-5 Specify electrode Device: Restore Advance Pulse Generator Not Applicable

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 4 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Recovery of Cardiovascular Function With Epidural Stimulation After Human Spinal Cord Injury
Study Start Date : January 2014
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Epidural Stimulation
80 sessions each of epidural spinal cord stimulation for 1) cardiovascular function; 2) voluntary movement; and 3) standing.
Device: 5-6-5 Specify electrode
Device: Restore Advance Pulse Generator



Primary Outcome Measures :
  1. Recovery of Autonomic control of Cardiovascular function [ Time Frame: 20 months ]

Secondary Outcome Measures :
  1. Recovery of Autonomic control of respiratory function [ Time Frame: 20 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02037620


Locations
United States, Kentucky
University of Louisville
Louisville, Kentucky, United States, 40202
Sponsors and Collaborators
University of Louisville
Investigators
Principal Investigator: Susan J Harkema, PhD University of Louisville

Responsible Party: Susan Harkema, Professor, University of Louisville
ClinicalTrials.gov Identifier: NCT02037620     History of Changes
Other Study ID Numbers: IB140483CVEpiStim
ES2-CHN-2013(SH) ( Other Grant/Funding Number: CDRF )
First Posted: January 16, 2014    Key Record Dates
Last Update Posted: February 28, 2018
Last Verified: February 2018

Keywords provided by Susan Harkema, University of Louisville:
Epidural Stimulation

Additional relevant MeSH terms:
Wounds and Injuries
Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System