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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: Low Hertz | Experimental | Participants will receive 10 hertz stimulation to the left auricular branch of the vagus nerve, delivered in one 15 minute session. Device: InTENsity MicroCombo |
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| Group 1: High Hertz | Experimental | Participants will receive 30 hertz stimulation to the left auricular branch of the vagus nerve, delivered in one 15 minute session. Device: InTENsity MicroCombo |
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| Group 1: Control | Sham Comparator | Participants will receive 30 hertz stimulation to a non-vagally innervated region of the left ear, delivered in one 15 minute session. Device: InTENsity MicroCombo |
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| Group 2: Pre-stressor | Experimental | Participants will receive 10 or 30 hertz stimulation to the left auricular branch of the vagus nerve, delivered in one 15 minute session prior to receiving experimental sympathetic induction. Device: InTENsity MicroCombo |
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| Group 2: Post-stressor | Experimental | Participants will receive 10 or 30 hertz stimulation to the left auricular branch of the vagus nerve, delivered in one 15 minute session after experimental sympathetic induction. Device: InTENsity MicroCombo |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| InTENsity MicroCombo | Device | An electrotherapy device. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in parasympathetic activity after vagal nerve stimulation by Heart Rate Variability | Measured by the normal-to-normal QRS complexes of the PQRST waveform of the electrocardiogram (ECG) | Baseline to 90 minutes post-vagal nerve stimulation |
| Measure | Description | Time Frame |
|---|---|---|
| Group 1 & 4: Change in acute heart rate response to vagal nerve stimulation | Measured by numerical heart rate in beats per minute | Baseline to 90 minutes post-vagal nerve stimulation |
| Group 1 & 4: Change in acute blood pressure response to vagal nerve stimulation |
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Group 1 & 2:
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| Name | Affiliation | Role |
|---|---|---|
| Mark S Nash, Ph.D. | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Miami Project to Cure Paralysis/ University of Miami | Miami | Florida | 33136 | United States |
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| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
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| Group 2: Control | Placebo Comparator | Participants will receive 10 or 30 hertz stimulation to a non-vagally innervated region of the left ear, delivered in one 15 minute session prior to receiving experimental sympathetic induction. Device: InTENsity MicroCombo |
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| Group 3: 30 Hz | Experimental | Participants will receive 10 or 30 hertz stimulation to the left auricular branch of the vagus nerve, delivered in one 15 minute session. Device: InTENsity MicroCombo |
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| Group 4: 30 Hz | Experimental | Participants will receive 10 or 30 hertz stimulation to the left auricular branch of the vagus nerve, delivered in one 15 minute session. Participants will also receive stimulation on a subsequent session prior to urodynamic testing. Device: InTENsity MicroCombo |
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| Group 1: Response | Experimental | Participants will receive 10-30 hertz stimulation to the left auricular branch of the vagus nerve, delivered over the course of 1 hour. Device: InTENsity MicroCombo |
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Measured by diastolic and systolic blood pressure (mm/Hg) |
| Baseline to 90 minutes post-vagal nerve stimulation |
| Group 1: Change in parasympathetic activity after vagal nerve stimulation by Vagus Somatosensory Evoked Potentials | Measured by far field potentials from the brain stem | Baseline to 90 minutes post-vagal nerve stimulation |
| Group 2 & 4: Change in acute physiological stress response by a change in peripheral cortisol | Measured by cortisol levels in plasma | Baseline to 90 minutes post-experimental stimulus |
| Group 2 & 4: Change in acute physiological stress response by a change in peripheral catecholamines | Measured by catecholamine levels in plasma | Baseline to 90 minutes post-experimental stimulus |
| Group 2 & 4: Change in acute physiological stress response by a change in heart rate | Measured by numerical heart rate in beats per minute | Baseline to 90 minutes post-experimental stimulus |
| Group 2 & 4: Change in acute physiological stress response by a change in blood pressure | Measured by diastolic and systolic blood pressure (mm/Hg) | Baseline to 90 minutes post-experimental stimulus |
| Group 3 & 4: Change in inflammatory biomarkers after vagal nerve stimulation | Measured by cytokine levels in plasma | Baseline to 90 minutes post-vagal nerve stimulation |
| D014947 | Wounds and Injuries |