Effect of (TaVNS) on Anxiety and Brain Function in Distressed Health Care Workers (fMRIVNS)
Anxiety, Distress, Emotional, Effects of Vibration
About this trial
This is an interventional supportive care trial for Anxiety focused on measuring Vagal Nerve Stimulation, Distressed Workers, Work-related Stress, Magnetic Resonance Imaging (MRI), Functional Magnetic Resonance Imaging (fMRI), Healthy Controls
Eligibility Criteria
Inclusion Criteria:
- Healthy male and female persons who work in health care and health care workers (all races and ethnicity) >21 years of age
- Health care worker with reported job related distress scored as at least a 6 or greater on the SUDS distress level from 1 to 10.
- Distressing job related recollection(s) that causes physiological reactivity (i.e., increased heart rate and/or increased skin conductance level - SCL), as described above.
- All subjects must have a smartphone device that can be used in conjunction the Neuvana 2.0
- Drug-free from medications that may affect brain physiology such that the imaging results will not be useful as determined by the PI.
- Able to understand and provide signed informed consent. Available and willing to be followed -up according to study protocol
- Female subjects of childbearing potential have a negative pregnancy test
- Subjects have no significant medical neurological or psychological disorders
- Stable health problems that should have no substantial effect on cerebral blood flow will be allowed (i.e. controlled hypertension, medication controlled diabetes).
- 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).
- 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.
or
Healthy control with no distress or other exclusion criteria
Exclusion Criteria:
- Any medical conditions that may interfere with cerebral blood flow as determined by the PI.
- 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)
- Subject is unable or unwilling to lie still in the scanner (i.e. due to claustrophobia or weight)
- Subject has metal in their body or other reason that they cannot undergo magnetic resonance imaging.
- Previous brain surgery or intracranial abnormalities they may complicate interpretation of the brain scans (e.g., stroke, tumor, vascular abnormality).
- Pregnancy or breastfeeding
- Concurrent participation in another research protocol that might affect the outcome of this study.
- Use of a defibrillator or pacemaker or other implanted or metallic electronic device. Doing so could cause electric shock, burns, electrical interference, or death.
- Epilepsy
- History of Seizures
- Temporomandibular Joint Disorder, Bell's Palsy, impaired cranial nerve function, or facial pain.
Sites / Locations
- Thomas Jefferson University, Marcus Institute of Integrative Health CentersRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Active Comparator
Active Comparator
Other
Transcutaneous Auricular Vagal Nerve Stimulation Intervention Group Distressed Healthcare Workers
Waitlist Control Distressed Healthcare Workers Delayed TaVNS Group
Healthy Controls: Group II and III
Two subgroups will be included in fMRI in the Active Comparator Group where scans performed during the initial evaluation period (pre) and at 3 months (post). Subgroup I of 30 subjects will undergo fMRI scans that will include structural imaging and functional imaging with Blood Oxygen Level Dependent Imaging (BOLD) scan and two arterial spin labeling (ASL) scans. This same imaging protocol, which takes a total of about 45 minutes, will be performed initially and then after the 3 month TaVNS program or the waitlist period. All scans will be co-registered and comparable slices of the cerebral cortex will be examined. Subgroup II will consist of 10 study subjects all receiving the TaVNS program who will undergo fMRI initially and then again at 3 months. This group will be scanned while wearing the TaVNS system (a special one that can be used in the MRI environment) and the fMRI will be used to evaluate the direct effects of the TaVNS while turned on and off in the scanner.
After baseline and 3 month imaging is completed. The waitlist control subgroups will be included in fMRI scans performed during the initial evaluation period (pre) and at 3 months (post). Subgroup I of 30 subjects will undergo fMRI scans that will include structural imaging and functional imaging with Blood Oxygen Level Dependent (BOLD) scan and two arterial spin labeling (ASL) scans. a typical morning waking up). This same imaging protocol, will be performed initially and then after the 3 month waitlist period. All scans will be co-registered and comparable slices of the cerebral cortex will be examined. After the waitlist imaging is completed the subjects will be offered the TaVNS health device.
The Investigators will also plan to recruit 10 healthy controls with no reports of psychological distress (i.e. less than 2 on the SUDS). These 10 healthy controls will have the TaVNS placed while receiving two fMRI scans approximately 3 months apart. These control subjects will be used to compare the subgroup of study subjects to ensure that any changes are not associated with test-retest effects.the Investigators also plan to recruit 50 additional healthy controls with no reports of psychological distress (i.e. less than 2 on the SUDS.) These 50 controls will have the TaVNS placed while receiving one fMRI scan sequence in one day while wearing a non-metalllic set of the TaVNS ear buds to evaluate the effects of the functional changes that may occur in the brain while using the TaVNS device.