Recovery of Cardiovascular Function With Epidural Stimulation After Human Spinal Cord Injury
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Spinal Cord Injury
- Sponsor
- University of Louisville
- Enrollment
- 5
- Locations
- 1
- Primary Endpoint
- Mean Arterial Blood Pressure in Response to Epidural Stimulation
- Status
- Completed
- Last Updated
- 4 years ago
Overview
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.
Investigators
Susan Harkema
Professor
University of Louisville
Eligibility Criteria
Inclusion Criteria
- Not provided
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.
Outcomes
Primary Outcomes
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.