Using Vagal Nerve Stimulation to Reduce Anxiety in Health Care Workers
Effect of Transcutaneous Auricular Vagus Nerve Stimulation (TAVNS) on Anxiety and Brain Function in Distressed Healthcare Professionals
This study is testing if a new treatment using Vagal Nerve Stimulation can help reduce anxiety in health care workers who are feeling stressed.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 21 Years and up |
| Sex | All |
| Sponsor | Thomas Jefferson University Academic / other |
| Locations | 1 site (Philadelphia, Pennsylvania) |
| Trial ID | NCT05132881 on ClinicalTrials.gov |
What this trial studies
This research aims to evaluate the effects of Transauricular Vagal Nerve Stimulation (TaVNS) on anxiety and brain function in distressed health care workers in Philadelphia. The study will involve screening up to 90 participants, with 80 expected to complete the study, who will be randomized into either a TaVNS treatment group or a waitlist control group. Participants will undergo initial evaluations and follow-up assessments using various symptom questionnaires and physiological measures, including heart rate variability and galvanic skin resistance, to assess changes in distress and neurophysiology. The study will utilize functional magnetic resonance imaging (fMRI) to observe alterations in brain activity associated with TaVNS use.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy adults over 21 years old who work in health care and experience distress or anxiety.
Not a fit: Patients with significant medical, neurological, or psychological disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a non-invasive treatment option for reducing anxiety and distress among health care workers.
How similar studies have performed: While the use of Vagal Nerve Stimulation is gaining interest, this specific application in distressed health care workers is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Philadelphia, Pennsylvania
- Thomas Jefferson University, Marcus Institute of Integrative Health Centers — Philadelphia, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Andrew B Newberg — Department of Integrative Medicine and Nutritional Sciences
- Study coordinator: Andrew B Newberg, MD
- Email: andrew.newberg@jefferson.edu
- Phone: 215-503-9070
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.