Effect of (TaVNS) on Anxiety and Brain Function in Distressed Health Care Workers

Launched by THOMAS JEFFERSON UNIVERSITY · Nov 12, 2021

Keywords

ClinConnect Summary

This clinical trial is studying how a device called Transauricular Vagal Nerve Stimulation (TaVNS) can help reduce anxiety and improve brain function in healthcare workers who are feeling distressed. The researchers aim to understand how this device affects the brain by using a special imaging technique called functional magnetic resonance imaging (fMRI). They believe that using TaVNS may lower feelings of distress and bring about positive changes in brain activity.

To participate in this study, you need to be a healthy adult over 21 who works in healthcare and has a smartphone that can connect to the TaVNS device. You should also be free from conditions or medications that might affect how your brain works. If you experience significant distress, as measured by a simple scale, you may qualify for the main part of the study. There’s also a group for those who don’t feel distressed, which helps the researchers compare results. Participants will use the TaVNS device during fMRI scans to observe any changes in brain activity. If you decide to join, you’ll receive support and information throughout the process to ensure your safety and understanding of the study.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Healthy male and female persons who work in health care and health care workers (all races and ethnicity) \>21 years of age
• • 2. All subjects must have a smartphone device that can be used in conjunction the Neuvana 2.0
• • 3. Drug-free from medications that may affect brain physiology such that the imaging results will not be useful as determined by the PI.
• • 4. Able to understand and provide signed informed consent. Available and willing to be followed -up according to study protocol
• • 5. Female subjects of childbearing potential have a negative pregnancy test
• • 6. Subjects have no significant medical neurological or psychological disorders
• • 7. Stable health problems that should have no substantial effect on cerebral blood flow will be allowed (i.e. controlled hypertension, medication controlled diabetes).
• • 8. Current medications and supplements will be reviewed by the Principal Investigator or a designated physician or health practitioner. Subjects may take medications or supplements but should be on a stable dose regimen for at least 3 months. For those receiving TaVNS program, it is preferable that subjects remain on that dose for the full TaVNS program period (with the exception of having an adverse reaction in which the medication or supplement must be stopped).
• • 9. PI will evaluate each subject for any potential medical issues that might be a problem and will consult with the subject's primary care provider if there are any questions about it.
• • Additional Inclusion Criteria for the TaVNS program for Distressed Workers
• • 1. Distress scored as at least a 6 or greater on the SUDS distress level from 1 to 10.
• • 2. Distressing recollection(s) that causes physiological reactivity (i.e., increased heart rate and/or increased skin conductance level - SCL), as described above.
• • Healthy control with no distress or other exclusion criteria
• Exclusion Criteria:
• • 1. Any medical conditions that may interfere with cerebral blood flow as determined by the PI.
• • 2. Currently taking medication that might affect cerebral blood flow as per the P.I. (i.e. antidepressants, antipsychotics, anxiolytics, benzodiazepines, sedatives, anti-seizure medications, but with the exception of those described above)
• • 3. Subject is unable or unwilling to lie still in the scanner (i.e. due to claustrophobia or weight)
• • 4. Subject has metal in their body or other reason that they cannot undergo magnetic resonance imaging.
• • 5. Previous brain surgery or intracranial abnormalities they may complicate interpretation of the brain scans (e.g., stroke, tumor, vascular abnormality).
• • 6. Pregnancy or breastfeeding
• • 7. Concurrent participation in another research protocol that might affect the outcome of this study.
• • 8. Use of a defibrillator or pacemaker or other implanted or metallic electronic device. Doing so could cause electric shock, burns, electrical interference, or death.
• • 9. Epilepsy
• • 10. History of Seizures
• • 11. Temporomandibular Joint Disorder, Bell's Palsy, impaired cranial nerve function, or facial pain.