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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

January 14, 2014
January 16, 2014
February 28, 2018
January 2014
December 2020   (Final data collection date for primary outcome measure)
Recovery of Autonomic control of Cardiovascular function [ Time Frame: 20 months ]
Not Provided
Complete list of historical versions of study NCT02037620 on ClinicalTrials.gov Archive Site
Recovery of Autonomic control of respiratory function [ Time Frame: 20 months ]
Not Provided
Not Provided
Not Provided
 
Recovery of Cardiovascular Function With Epidural Stimulation After Human Spinal Cord Injury
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.
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.
Interventional
Not Applicable
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Spinal Cord Injury
  • Device: 5-6-5 Specify electrode
  • Device: Restore Advance Pulse Generator
Experimental: Epidural Stimulation
80 sessions each of epidural spinal cord stimulation for 1) cardiovascular function; 2) voluntary movement; and 3) standing.
Interventions:
  • Device: 5-6-5 Specify electrode
  • Device: Restore Advance Pulse Generator
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
4
Not Provided
December 2022
December 2020   (Final data collection date for primary outcome measure)
  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.
Sexes Eligible for Study: All
21 Years to 70 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT02037620
IB140483CVEpiStim
ES2-CHN-2013(SH) ( Other Grant/Funding Number: CDRF )
No
Not Provided
Not Provided
Susan Harkema, University of Louisville
University of Louisville
Not Provided
Principal Investigator: Susan J Harkema, PhD University of Louisville
University of Louisville
February 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP