ACTIVE_NOT_RECRUITING

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

Conditions

Anxiety Distress, Emotional Effects of Vibration Healthy Vagal Nerve Stimulation Distressed Workers Work-related Stress Magnetic Resonance Imaging (MRI)Functional Magnetic Resonance Imaging (fMRI)Healthy Controls

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of this research is to measure alterations in anxiety and brain activity associated with the use of an approved health device called Transauricular Vagal Nerve Stimulation (TaVNS) in distressed persons who work in a health care and distressed healthcare workers in the the Philadelphia, PA region. The Investigators will be using functional magnetic resonance imaging (or fMRI) to measure changes in each subject's brain function during the use of VNS. This study is designed to allow researchers to understand the changes in cerebral (brain) activity that occur when a subject uses VNS. Thus, the primary goal of the proposed study is to evaluate the ability of the TaVNS system to reduce distress and change neurophysiology among health care providers. The Investigators, hypothesize that using the TaVNS device will help reduce distress in individuals. In order to understand the mechanisms of change that occur while using the VNS study, the Investigators have added a substudy of participants who do not experience high levels of distress to evaluate the effects of the functional changes that may occur in the brain while using the TaVNS device. In addition to the primary aims of the overalll study to assess distress in workers while enrolled in a TaVNS program, a subgroup of 50 subjects will undergo functional magnetic resonance imaging (fMRI) while using the VNS device to assess the changes in the brain including neurophysiological effects of TaVNS. The goal of this substudy is to observe the changes in the brain while using the TaVNS earbuds in the MRI to increase our understanding of the mechanisms and processing involved while using TaVNS. In this substudy, which is amendment version 3.0, the investigators have increased the number of persons to include 50 subjects who will use the device in the MRI to evaluate the neural processes and cerebral blood flow while using TaVNS.

Official Title

Effect of Transcutaneous Auricular Vagus Nerve Stimulation (TAVNS) on Anxiety and Brain Function in Distressed Healthcare Professionals

Quick Facts

Study Start:2021-04-01

Study Completion:2025-11-20

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05132881

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:21 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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. 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.	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.

Inclusion Criteria

Exclusion 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.
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.

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.

Contacts and Locations

Principal Investigator

Andrew B Newberg

PRINCIPAL_INVESTIGATOR

Department of Integrative Medicine and Nutritional Sciences

Study Locations (Sites)

Thomas Jefferson University, Marcus Institute of Integrative Health Centers

Philadelphia, Pennsylvania, 19107

United States

Collaborators and Investigators

Sponsor: Thomas Jefferson University

Andrew B Newberg, PRINCIPAL_INVESTIGATOR, Department of Integrative Medicine and Nutritional Sciences

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-04-01

Study Completion Date2025-11-20

Study Record Updates

Study Start Date2021-04-01

Study Completion Date2025-11-20

Terms related to this study

Keywords Provided by Researchers

Vagal Nerve Stimulation
Distressed Workers
Work-related Stress
Magnetic Resonance Imaging (MRI)
Functional Magnetic Resonance Imaging (fMRI)
Healthy Controls

Additional Relevant MeSH Terms

Anxiety
Distress, Emotional
Effects of Vibration
Healthy