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

Not Applicable

Completed

• Conditions: Spinal Cord Injury
• Interventions: Device: 5-6-5 Specify electrode; Device: Restore Advance Pulse Generator

• Registration Number: NCT02037620
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2014-01-14
• Study First Submitted QC: 2014-01-14
• Study First Posted: 2014-01-16
• Study Start: 2014-07
• Primary Completion: 2019-09-20
• Study Completion: 2019-09-20
• Results First Submitted: 2021-09-17
• Status Verified: 2022-03
• Results First Submitted QC: 2022-03-02
• Last Update Submitted: 2022-03-02
• Results First Posted: 2022-03-28
• Last Update Posted: 2022-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5

Inclusion Criteria

Not provided

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Mean Arterial Blood Pressure in Response to Epidural Stimulation	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.

Trial Locations

Locations (1)

University of Louisville; 🇺🇸 Louisville, Kentucky, United States