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

N/ACompletedNCT02037620

University of Louisville5 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Spinal Cord Injury

Interventions

5-6-5 Specify electrodeDEVICE

Restore Advance Pulse GeneratorDEVICE

Eligibility

Sex: ALLMin age: 21 YearsMax age: 70 Years

Medical Language ↔ Plain English

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.

Locations (1)

University of Louisville

Louisville, Kentucky, United States

Outcomes

Primary Outcomes

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.

Time frame: 20 months

Data from ClinicalTrials.gov

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