Spinal Cord Injury
Conditions
Keywords
Epidural Stimulation
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.
Interventions
DEVICE5-6-5 Specify electrode
DEVICERestore Advance Pulse Generator
Sponsors
University of Louisville
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Epidural Stimulation 80 sessions each of epidural spinal cord stimulation for 1) cardiovascular function; 2) voluntary movement; and 3) standing.
5-6-5 Specify electrode
Restore Advance Pulse Generator | 4 |
| Total | 4 |
Baseline characteristics
| Characteristic | Epidural Stimulation | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 0 Participants | — |
| Age, Categorical Between 18 and 65 years | 4 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 1 Participants | — |
| Sex: Female, Male Male | 3 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 5 |
| other Total, other adverse events | 1 / 5 |
| serious Total, serious adverse events | 3 / 5 |
Outcome results
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Epidural Stimulation | Mean Arterial Blood Pressure in Response to Epidural Stimulation | 112.5 mmHg | Standard Deviation 8.25 |