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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02037620
Recruitment Status : Recruiting
First Posted : January 16, 2014
Last Update Posted : April 14, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:

In this study, we would like to demonstrate that epidural stimulation can be used to recover significant levels of autonomic control of the 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.

Rationale:

We propose to determine the functional gain that can be achieved in voluntary control of movements below the level of injury and autonomic nervous system function as a result of activation of spinal circuits with epidural stimulation (ES) in humans with complete motor paralysis. In addition to the scientific advances, the proposed experiments are essential to translating this therapeutic approach to a larger scale, which is needed to have a meaningful clinical impact. ES for recovery of neurological function in patients with severe SCI is not widely used because of uncertainty regarding the mechanisms of action and convincing evidence of efficacy in a larger numbers of subjects. Our approach will allow us to determine specific types of ES needed for voluntary movement and autonomic nervous system dysfunction which lays the groundwork for expedient translation to larger numbers of individuals with SCI.

Current clinical methods of diagnosis of clinically complete SCI may not be sensitive enough to detect residual functional synapses across the lesion. We propose to use a series of neurophysiological approaches that can detect different sources of supraspinal influence on spinal circuitry and identify specific pathways including vestibulospinal, reticulospinal, corticospinal and long propriospinal pathways that may remain viable or emerge with ES and task specific training after complete motor paralysis. Such residual connectivity would be identified by the presence of voluntarily controlled movement or evoked motor potentials occurring only in the presence of epidural stimulation. Identifying the essential supraspinal-spinal pathways needed to recovery these voluntary movements will advance our knowledge of human neural control of movement and provide critical information for developing repair and regeneration strategies and in determining the type and severity of patient that could benefit most readily in regaining voluntary control using epidural stimulation.


Condition or disease Intervention/treatment
Spinal Cord Injury Device: 5-6-5 Specify electrode Device: Restore Advance Pulse Generator

  Show Detailed Description

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 4 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Epidural Stimulation

5-6-5 Specify Electrode

Restore Advance Pulse Generator

Device: 5-6-5 Specify electrode Device: Restore Advance Pulse Generator


Outcome Measures

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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion 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.
Contacts and Locations

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 Recruiting
Louisville, Kentucky, United States, 40202
Contact: Susan J Harkema, PhD    502-581-7443    locomotorresearch@kentuckyonehealth.org   
Principal Investigator: Susan J Harkema, PhD         
Sponsors and Collaborators
University of Louisville
Investigators
Principal Investigator: Susan J Harkema, PhD University of Louisville
More Information

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: April 14, 2017
Last Verified: April 2017

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