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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-31

Study Completion Date

2019-09-20

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Spinal Cord Injury

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Epidural Stimulation

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

Group Type EXPERIMENTAL

5-6-5 Specify electrode

Intervention Type DEVICE

Restore Advance Pulse Generator

Intervention Type DEVICE

Interventions

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5-6-5 Specify electrode

Intervention Type DEVICE

Restore Advance Pulse Generator

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

21 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No