fMRIVNS: Effect of (TaVNS) on Anxiety and Brain Function in Distressed Health Care Workers
Study Details
Study Description
Brief Summary
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 overall goal of the proposed study is to evaluate the ability of the TaVNS system to reduce distress and change neurophysiology among health care providers.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Detailed Description
A total of up to 90 distressed persons who work in health care and health care providers in the Philadelphia, PA region, will be screened for this study. From that group, the researchers plan to enroll enough subjects to have 80 fully complete the study. The 90 screened subjects will allow for screen failures and subjects who withdraw early from the study. All subjects will receive an initial evaluation using symptom questionnaires (these will include the Global Severity Index of the Brief Symptom Inventory-18 which is the primary outcome, and secondary outcomes as measured by the Maslach Burnout Scale, GAD-7 (anxiety), PHQ-9 (depression), the Connor Davidson Resilience Scale-25 (CD-RISC), and the Insomnia Severity Index (ISI) and physiological measures that will consist of heart rate variability (HRV) and galvanic skin resistance (GSR). Subjects will then be randomized to either the 3 month TaVNS program or the 3 month waitlist group. At one month, subjects will receive a follow up request to complete the same questionnaires as in the initial evaluation for an interim evaluation. Then after receiving the TaVNS program or being in the waitlist control group for 3 months, the subjects will have a repeat of the questionnaires and physiological testing. Subjects in the waitlist group will then be provided the TaVNS program to be used for 3 months. This group will be asked to complete one final set of symptom questionnaires at the completion of using the TaVNS program.
Two subgroups will be included in fMRI scans performed during the initial evaluation period (pre) and at 3 months (post). Subgroup I of 30 subjects (15 in TaVNS group and 15 in waitlist control) will undergo fMRI scans that will include structural imaging and functional imaging with Blood Oxygen Level Dependent Imaging (BOLD) scan and arterial spin labeling (ASL) scans. Specifically, during the ASL scans (each approximately 5 minutes long), a script of the subject's most distressing recollection(s) will be read from an audio file script while each subject is in the MRI scanner. Changes in brain function will be compared between the stress script and a neutral script (that describes a typical morning waking up). 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. The imaging protocol will take a total of about 45 minutes. In addition to the 10 study subjects, the researchers 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 subgroups will be filled with eligible and interested subjects. If the subject is interested and is able to undergo fMRI scanning, the subject will be placed in Subgroup I until enrollment is filled and then subsequently subjects will be enrolled into Subgroup II until enrollment is filled. Any eligible subject that is unwilling or unable to undergo fMRI scanning will be placed in the general, non-scanning group. Once the two subgroups are filled, any remaining eligible subjects will be placed in the general, non-scanning group.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Transcutaneous Auricular Vagal Nerve Stimulation Intervention Group Distressed Healthcare Workers 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. |
Other: Neuvana 2.0 Transcutaneous Auricular Vagal Nerve Stimulation (TaVNS)
The intervention administered is the TaVNS program and the fMRI scans to evaluate changes in the brain. The TaVNS program consists of placing ear buds from the device into each ear. They are initially sprayed once with a small amount of saline that is also provided as part of the TaVNS materials. Once the ear buds are placed in each ear, the test subject will start a preprogramed session of vibrations that will stimulate the vagus nerve. The session will last for 15 minutes and then the subject will take the ear buds out and clean them. They will use the TaVNS program once a day for 3 months.
Other Names:
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| Other: Waitlist Control Distressed Healthcare Workers Delayed TaVNS Group 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. |
Other: Waitlist Control
Baseline imaging and follow up imaging for comparison to the TaVNS health device 3 group at approximately 3 months. The TaVNS intervention is offered after completion of the imaging.
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| Active Comparator: Healthy Controls 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. |
Other: Neuvana 2.0 Transcutaneous Auricular Vagal Nerve Stimulation (TaVNS)
The intervention administered is the TaVNS program and the fMRI scans to evaluate changes in the brain. The TaVNS program consists of placing ear buds from the device into each ear. They are initially sprayed once with a small amount of saline that is also provided as part of the TaVNS materials. Once the ear buds are placed in each ear, the test subject will start a preprogramed session of vibrations that will stimulate the vagus nerve. The session will last for 15 minutes and then the subject will take the ear buds out and clean them. They will use the TaVNS program once a day for 3 months.
Other Names:
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Outcome Measures
Primary Outcome Measures
- Subjective Units of Distress Survey [Screening Measure Subjects will be evaluated at baseline.]
The Subjective Units of Distress Survey (SUDS) is a way for participants to communicate how much distress they are currently feeling using a 0 to 10 scale with zero corresponding to a relaxed state without distress and ten corresponding to extreme distress filled with panic, tension, fear, and anxiety.
- Subjective Units of Distress Survey [Change from baseline and after using the TaVNS system approximately 90 days (~3 months)] .]
The Subjective Units of Distress Survey (SUDS) is a way for participants to communicate how much distress they are currently feeling using a 0 to 10 scale with zero corresponding to a relaxed state without distress and ten corresponding to extreme distress filled with panic, tension, fear, and anxiety.
- Heart Rate Variability [Screening Measure Subjects will be evaluated at baseline]
Heart rate variability (HRV) is the physiological phenomenon of the variation in the time interval between consecutive heartbeats in milliseconds.
- Heart Rate Variability [Change from baseline and after using the TaVNS system approximately 90 days (~3 months)] .]
Heart rate variability (HRV) is the physiological phenomenon of the variation in the time interval between consecutive heartbeats in milliseconds.
- Galvanic Skin Resistance (GSR) [Screening Measure Subjects will be evaluated at baseline]
To measure changes in sweat gland activity, which reflect the intensity of participants' emotional state
- Galvanic Skin Resistance (GSR) [Change from baseline and after using the TaVNS System approximately 90 days (~3 months)]]
To measure changes in sweat gland activity, which reflect the intensity of participants' emotional state
- Functional magnetic resonance imaging (fMRI) [Subjects will be evaluated at baseline]
This scan will be used to assess functional connectivity, tractography, and brain volume
- Functional magnetic resonance imaging (fMRI) [Change from baseline and after using the TaVNS system approximately 90 days (~3 months)] .]
This scan will be used to assess functional connectivity, tractography, and brain volume
- Blood Oxygen Level Dependent Imaging scan [Subject will be evaluated at baseline]
Blood Oxygen Level Dependent Imaging (BOLD) scan analysis, used to observe different areas of the brain or other organs, which are found to be active at any given time.
- Blood Oxygen Level Dependent Imaging scan [Change from baseline and after using the TaVNS System approximately 90 days (~3 months)]]
Blood Oxygen Level Dependent Imaging (BOLD) scan fMRI analysis, used to observe different areas of the brain or other organs, which are found to be active at any given time.
- Arterial spin labeling scan [Subjects will be evaluated at baseline]
Arterial spin labeling (ASL) scan fMRI analysis, used to quantify cerebral blood perfusion by labelling blood water as it flows throughout the brain.
- Arterial spin labeling scan [Change from baseline and after using the TaVNS System approximately 90 days (~3 months)]]
Arterial spin labeling (ASL) scan fMRI analysis used to quantify cerebral blood perfusion by labelling blood water as it flows throughout the brain.
Secondary Outcome Measures
- The Maslach Burnout Scale [Subjects will be evaluated at baseline with questionnaires.]
To measure feelings of being emotionally overextended and exhausted for health care professionals.The higher the score in each subgroup, the higher the emotional exhaustion and depersonalization, or the lower the sense of personal accomplishment.
- The Maslach Burnout Scale [Subjects will be evaluated at approximately three months follow up with questionnaires.]
To measure feelings of being emotionally overextended and exhausted for health care professionals.The higher the score in each subgroup, the higher the emotional exhaustion and depersonalization, or the lower the sense of personal accomplishment.
- The Maslach Burnout Scale [Subjects will be evaluated approximately six months follow up with questionnaires.]
To measure feelings of being emotionally overextended and exhausted for health care professionals. The higher the score in each subgroup, the higher the emotional exhaustion and depersonalization, or the lower the sense of personal accomplishment.
- Patient Health Questionnaire [Subjects will be evaluated at baseline with questionnaires.]
Patient Health Questionnaire (PHQ-9)(depression) is the depression module to monitor the severity of depression and response to treatment. The range of the possible scores for the PHQ-9 are 0-27 with higher scores for worse symptoms.
- Patient Health Questionnaire [Subjects will be evaluated at approximately three months follow up with questionnaires.]
Patient Health Questionnaire (PHQ-9)(depression) is the depression module to monitor the severity of depression and response to treatment. The range of the possible scores for the PHQ-9 are 0-27 wither higher scores for worse symptoms.
- Patient Health Questionnaire (PHQ-9)(depression) [Subjects will be evaluated at baseline and approximately six months follow up with questionnaires.]
Patient Health Questionnaire (PHQ-9)(depression) is the depression module to monitor the severity of depression and response to treatment.The range of the possible scores for the PHQ-9 are 0-27 with higher scores for worse symptoms.
- General Anxiety Disorder [Subjects will be evaluated at baseline with questionnaires.]
The General Anxiety Disorder (GAD-7) is a valid tool for screening for General Anxiety Disorder and assessing its severity. The GAD-7 consists of 7 questions that correspond to scores of anxiety. The range of scores is from 0 to 21; a higher score indicates greater anxiety.
- General Anxiety Disorder [Subjects will be evaluated at baseline and approximately three months follow up with questionnaires.]
The General Anxiety Disorder (GAD-7) is a valid tool for screening for General Anxiety Disorder and assessing its severity. The GAD-7 consists of 7 questions that correspond to scores of anxiety. The range of scores is from 0 to 21; a higher score indicates greater anxiety.
- General Anxiety Disorder [Subjects will be evaluated at baseline and approximately six months follow up with questionnaires.]
The General Anxiety Disorder (GAD-7) is a valid tool for screening for General Anxiety Disorder and assessing its severity. The GAD-7 consists of 7 questions that correspond to scores of anxiety. The range of scores is from 0 to 21; a higher score indicates greater anxiety.
- Connor Davidson Resilience Scale-25 (CD-RISC) [Subjects will be evaluated at baseline with questionnaires.]
The Conner Davidson Resilience Scale-25 (CD-RISC-25) consists of 25 questions. The range of possible scores is 0-100 with a higher score indicating a higher chance of resiliency. The Connor-Davidson Resilience Scale is a test that measures resilience or how well one is equipped to bounce back after stressful events, tragedy, or trauma.
- Connor Davidson Resilience Scale-25 [Subjects will be evaluated at approximately three months follow up with questionnaires.]
The Conner Davidson Resilience Scale-25 (CD-RISC-25) consists of 25 questions. The range of possible scores is 0-100 with a higher score indicating a higher chance of resiliency. The Connor-Davidson Resilience Scale is a test that measures resilience or how well one is equipped to bounce back after stressful events, tragedy, or trauma.
- Connor Davidson Resilience Scale-25 [Subjects will be evaluated at baseline and approximately six months follow up with questionnaires.]
The Conner Davidson Resilience Scale-25 (CD-RISC-25) consists of 25 questions. The range of possible scores is 0-100 with a higher score indicating a higher chance of resiliency. The Connor-Davidson Resilience Scale is a test that measures resilience or how well one is equipped to bounce back after stressful events, tragedy, or trauma.
- Insomnia Severity Index [Subjects will be evaluated at baseline with questionnaires.]
The Insomnia Severity Index (ISI) is a brief instrument comprised of 7 questions designed to assess the severity of both nighttime and daytime components of insomnia. The scores are rated 0-28 with higher scores corresponding to more sleep difficulties.
- Insomnia Severity Index [Subjects will be evaluated at baseline and approximately three months follow up with questionnaires.]
The Insomnia Severity Index (ISI) is a brief instrument comprised of 7 questions designed to assess the severity of both nighttime and daytime components of insomnia. The scores are rated 0-28 with higher scores corresponding to more sleep difficulties.
- Insomnia Severity Index [Subjects will be evaluated at baseline and approximately six months follow up with questionnaires.]
The Insomnia Severity Index (ISI) is a brief instrument comprised of 7 questions designed to assess the severity of both nighttime and daytime components of insomnia. The scores are rated 0-28 with higher scores corresponding to more sleep difficulties.
- Global Severity Index of the Brief Symptom Inventory-18 [Subjects will be evaluated at baseline .]
The Brief Symptom Inventory (BSI-18) is a brief self-report survey to assess the extent of distress or annoyance. Responses were rated ranging from 1 to 5 for a total score of 18-90. A higher score indicates greater distress or annoyance.
- Global Severity Index of the Brief Symptom Inventory-18 [Subjects will be evaluated at three months after using the TaVNS system.]
The Brief Symptom Inventory (BSI-18) is a brief self-report survey to assess the extent of distress or annoyance. Responses were rated ranging from 1 to 5 for a total score of 18-90. A higher score indicates greater distress or annoyance.
- Global Severity Index of the Brief Symptom Inventory-18 [Subjects will be evaluated at six months after using the TaVNS system.]
The Brief Symptom Inventory (BSI-18) is a brief self-report survey to assess the extent of distress or annoyance. Responses were rated ranging from 1 to 5 for a total score of 18-90. A higher score indicates greater distress or annoyance.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Healthy male and female persons who work in health care and health care workers (all races and ethnicity) >21 years of age
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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.
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Distressing job related recollection(s) that causes physiological reactivity (i.e., increased heart rate and/or increased skin conductance level - SCL), as described above.
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All subjects must have a smartphone device that can be used in conjunction the Neuvana 2.0
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Drug-free from medications that may affect brain physiology such that the imaging results will not be useful as determined by the PI.
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Able to understand and provide signed informed consent. Available and willing to be followed -up according to study protocol
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Female subjects of childbearing potential have a negative pregnancy test
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Subjects have no significant medical neurological or psychological disorders
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Stable health problems that should have no substantial effect on cerebral blood flow will be allowed (i.e. controlled hypertension, medication controlled diabetes).
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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).
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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:
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Any medical conditions that may interfere with cerebral blood flow as determined by the PI.
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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)
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Subject is unable or unwilling to lie still in the scanner (i.e. due to claustrophobia or weight)
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Subject has metal in their body or other reason that they cannot undergo magnetic resonance imaging.
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Previous brain surgery or intracranial abnormalities they may complicate interpretation of the brain scans (e.g., stroke, tumor, vascular abnormality).
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Pregnancy or breastfeeding
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Concurrent participation in another research protocol that might affect the outcome of this study.
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Use of a defibrillator or pacemaker or other implanted or metallic electronic device. Doing so could cause electric shock, burns, electrical interference, or death.
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Epilepsy
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History of Seizures
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Temporomandibular Joint Disorder, Bell's Palsy, impaired cranial nerve function, or facial pain.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Thomas Jefferson University, Marcus Institute of Integrative Health Centers | Philadelphia | Pennsylvania | United States | 19107 |
Sponsors and Collaborators
- Thomas Jefferson University
Investigators
- Principal Investigator: Andrew B Newberg, Department of Integrative Medicine and Nutritional Sciences
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 221D.069