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

Primary Purpose

Spinal Cord Injury

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
5-6-5 Specify electrode
Restore Advance Pulse Generator
Sponsored by
University of Louisville
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Spinal Cord Injury focused on measuring Epidural Stimulation

Eligibility Criteria

21 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers
  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.

Sites / Locations

  • University of Louisville

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Epidural Stimulation

Arm Description

80 sessions each of epidural spinal cord stimulation for 1) cardiovascular function; 2) voluntary movement; and 3) standing.

Outcomes

Primary Outcome Measures

Mean Arterial Blood Pressure in Response to Epidural Stimulation
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.

Secondary Outcome Measures

Full Information

First Posted
January 14, 2014
Last Updated
March 2, 2022
Sponsor
University of Louisville
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1. Study Identification

Unique Protocol Identification Number
NCT02037620
Brief Title
Recovery of Cardiovascular Function With Epidural Stimulation After Human Spinal Cord Injury
Official Title
Recovery of Cardiovascular Function With Epidural Stimulation After Human Spinal Cord Injury
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
July 2014 (Actual)
Primary Completion Date
September 20, 2019 (Actual)
Study Completion Date
September 20, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Louisville

4. Oversight

Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injury
Keywords
Epidural Stimulation

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Epidural Stimulation
Arm Type
Experimental
Arm Description
80 sessions each of epidural spinal cord stimulation for 1) cardiovascular function; 2) voluntary movement; and 3) standing.
Intervention Type
Device
Intervention Name(s)
5-6-5 Specify electrode
Intervention Type
Device
Intervention Name(s)
Restore Advance Pulse Generator
Primary Outcome Measure Information:
Title
Mean Arterial Blood Pressure in Response to Epidural Stimulation
Description
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.
Time Frame
20 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susan J Harkema, PhD
Organizational Affiliation
University of Louisville
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Louisville
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
29867586
Citation
Aslan SC, Legg Ditterline BE, Park MC, Angeli CA, Rejc E, Chen Y, Ovechkin AV, Krassioukov A, Harkema SJ. Epidural Spinal Cord Stimulation of Lumbosacral Networks Modulates Arterial Blood Pressure in Individuals With Spinal Cord Injury-Induced Cardiovascular Deficits. Front Physiol. 2018 May 18;9:565. doi: 10.3389/fphys.2018.00565. eCollection 2018.
Results Reference
background
PubMed Identifier
29020054
Citation
Mesbah S, Angeli CA, Keynton RS, El-Baz A, Harkema SJ. A novel approach for automatic visualization and activation detection of evoked potentials induced by epidural spinal cord stimulation in individuals with spinal cord injury. PLoS One. 2017 Oct 11;12(10):e0185582. doi: 10.1371/journal.pone.0185582. eCollection 2017.
Results Reference
background
PubMed Identifier
30242310
Citation
Harkema SJ, Legg Ditterline B, Wang S, Aslan S, Angeli CA, Ovechkin A, Hirsch GA. Epidural Spinal Cord Stimulation Training and Sustained Recovery of Cardiovascular Function in Individuals With Chronic Cervical Spinal Cord Injury. JAMA Neurol. 2018 Dec 1;75(12):1569-1571. doi: 10.1001/jamaneurol.2018.2617.
Results Reference
result
PubMed Identifier
29568266
Citation
Harkema SJ, Wang S, Angeli CA, Chen Y, Boakye M, Ugiliweneza B, Hirsch GA. Normalization of Blood Pressure With Spinal Cord Epidural Stimulation After Severe Spinal Cord Injury. Front Hum Neurosci. 2018 Mar 8;12:83. doi: 10.3389/fnhum.2018.00083. eCollection 2018.
Results Reference
result

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

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