Spinal Cord Injury
Conditions
Keywords
Hyperadrenergia, Inflammatory stress
Brief summary
The purpose of this research device study is to learn more about the autonomic nervous system. This system uses nerves to send information from the brain to the rest of the body by electrical signaling and has two divisions, the sympathetic and the parasympathetic branches. It has been thought that electrical stimulation devices could be used to restore balance to the nervous system. Because most of the imbalance seems to happen due to too much sympathetic activity, the investigator plans to focus on the parasympathetic branch. Specifically, the investigator hopes to restore balance by targeting the vagus nerve, which is the main communicator of the parasympathetic branch. The study will examine whether the investigator can decrease sympathetic activity and chronic inflammation by increasing parasympathetic activity. This is a device study that will examine the use of non-invasive vagal nerve stimulation to attenuate inflammatory stress and sympathetic hyperactivity in persons with Spinal Cord Injury and Non-Disabled Controls.
Interventions
DEVICEInTENsity MicroCombo
An electrotherapy device.
Sponsors
University of Miami
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
Group 1 & 2: Inclusion Criteria: 1. Age 18-65 2. Willingness to participate in the study
Exclusion criteria
1. Use of an active electrical implant, such as a cardiac pacemaker or cochlear implant 2. Use of a hearing aid in the left ear 3. Use of an implanted insulin or morphine (pain) pump 4. Self-reported history of syncope from known or unknown origins 5. Self-reported history of cardiovascular disease or dysfunction (e.g., cardiovascular disease, arrhythmia, congestive heart failure, or stroke) Group 3: Inclusion Criteria: 1. Age 18-65 2. Overweight, with a BMI ≥ 27 3. Presence of chronic inflammation, with C-reactive protein values \> 3 mg/l 4. Willingness to participate in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in parasympathetic activity after vagal nerve stimulation by Heart Rate Variability | Baseline to 90 minutes post-vagal nerve stimulation | Measured by the normal-to-normal QRS complexes of the PQRST waveform of the electrocardiogram (ECG) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Group 1 & 4: Change in acute blood pressure response to vagal nerve stimulation | Baseline to 90 minutes post-vagal nerve stimulation | Measured by diastolic and systolic blood pressure (mm/Hg) |
| Group 1: Change in parasympathetic activity after vagal nerve stimulation by Vagus Somatosensory Evoked Potentials | Baseline to 90 minutes post-vagal nerve stimulation | Measured by far field potentials from the brain stem |
| Group 2 & 4: Change in acute physiological stress response by a change in peripheral cortisol | Baseline to 90 minutes post-experimental stimulus | Measured by cortisol levels in plasma |
| Group 1 & 4: Change in acute heart rate response to vagal nerve stimulation | Baseline to 90 minutes post-vagal nerve stimulation | Measured by numerical heart rate in beats per minute |
| Group 2 & 4: Change in acute physiological stress response by a change in heart rate | Baseline to 90 minutes post-experimental stimulus | Measured by numerical heart rate in beats per minute |
| Group 2 & 4: Change in acute physiological stress response by a change in blood pressure | Baseline to 90 minutes post-experimental stimulus | Measured by diastolic and systolic blood pressure (mm/Hg) |
| Group 3 & 4: Change in inflammatory biomarkers after vagal nerve stimulation | Baseline to 90 minutes post-vagal nerve stimulation | Measured by cytokine levels in plasma |
| Group 2 & 4: Change in acute physiological stress response by a change in peripheral catecholamines | Baseline to 90 minutes post-experimental stimulus | Measured by catecholamine levels in plasma |
Countries
United States
Outcome results
None listed