A Study of Safety and Autonomic Responses to Non-Invasive Vagal Stimulation in Persons With Spinal Cord Injury and Non-Disabled Controls Both With and Without Inflammatory Stress
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Spinal Cord Injury
- Sponsor
- University of Miami
- Locations
- 1
- Primary Endpoint
- Change in parasympathetic activity after vagal nerve stimulation by Heart Rate Variability
- Status
- Withdrawn
- Last Updated
- 7 years ago
Overview
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.
Investigators
Mark S. Nash, Ph.D., FACSM
Professor
University of Miami
Eligibility Criteria
Inclusion Criteria
- •Willingness to participate in the study
Exclusion Criteria
- •Use of an active electrical implant, such as a cardiac pacemaker or cochlear implant
- •Use of a hearing aid in the left ear
- •Use of an implanted insulin or morphine (pain) pump
- •Self-reported history of syncope from known or unknown origins
- •Self-reported history of cardiovascular disease or dysfunction (e.g., cardiovascular disease, arrhythmia, congestive heart failure, or stroke)
- •Inclusion Criteria:
- •Overweight, with a BMI ≥ 27
- •Presence of chronic inflammation, with C-reactive protein values \> 3 mg/l
- •Willingness to participate in the study
- •Exclusion Criteria:
Outcomes
Primary Outcomes
Change in parasympathetic activity after vagal nerve stimulation by Heart Rate Variability
Time Frame: 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 Outcomes
- Group 2 & 4: Change in acute physiological stress response by a change in heart rate(Baseline to 90 minutes post-experimental stimulus)
- Group 2 & 4: Change in acute physiological stress response by a change in peripheral cortisol(Baseline to 90 minutes post-experimental stimulus)
- Group 2 & 4: Change in acute physiological stress response by a change in peripheral catecholamines(Baseline to 90 minutes post-experimental stimulus)
- Group 1 & 4: Change in acute blood pressure response to vagal nerve stimulation(Baseline to 90 minutes post-vagal nerve stimulation)
- Group 1: Change in parasympathetic activity after vagal nerve stimulation by Vagus Somatosensory Evoked Potentials(Baseline to 90 minutes post-vagal nerve stimulation)
- Group 3 & 4: Change in inflammatory biomarkers after vagal nerve stimulation(Baseline to 90 minutes post-vagal nerve stimulation)
- Group 1 & 4: Change in acute heart rate response to vagal nerve stimulation(Baseline to 90 minutes post-vagal nerve stimulation)
- Group 2 & 4: Change in acute physiological stress response by a change in blood pressure(Baseline to 90 minutes post-experimental stimulus)