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TaVNS for Healthcare Worker Anxiety (fMRIVNS Trial)
N/A
Recruiting
Led By Andrew B Newberg
Research Sponsored by Thomas Jefferson University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Additional Inclusion Criteria for the TaVNS program for Distressed Workers: Distress scored as at least a 6 or greater on the SUDS distress level from 1 to 10. Distressing recollection(s) that cause physiological reactivity (i.e., increased heart rate and/or increased skin conductance level - SCL)
Subjects have no significant medical neurological or psychological disorders
Timeline
Screening 3 weeks
Treatment Varies
Follow Up subjects will be evaluated at baseline and approximately six months follow up with questionnaires.
Awards & highlights
fMRIVNS Trial Summary
This trial is measuring whether Transauricular Vagal Nerve Stimulation (TaVNS) can help with anxiety and brain activity in people who work in healthcare and are distressed. They will be using functional magnetic resonance imaging (fMRI) to see changes in brain function while using VNS.
Who is the study for?
This trial is for health care workers over 21 years old in Philadelphia experiencing distress, with stable health conditions like controlled hypertension or diabetes. They must be able to consent and follow the study protocol, have a smartphone compatible with Neuvana 2.0, and not be on brain-affecting drugs. Pregnant women can't participate.Check my eligibility
What is being tested?
The study tests if TaVNS (a non-invasive earbud device) reduces anxiety and changes brain function in distressed health care workers using fMRI scans. A subgroup of healthy controls will also use TaVNS to compare brain activity changes.See study design
What are the potential side effects?
Potential side effects from using the TaVNS device may include discomfort at the stimulation site or headaches. Since it's non-invasive, risks are minimal but could involve unexpected reactions like skin irritation.
fMRIVNS Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I feel very distressed, scoring at least a 6 out of 10, and have physical reactions to stressful memories.
Select...
I do not have any major neurological or psychological conditions.
Select...
I am of childbearing age and have a negative pregnancy test.
fMRIVNS Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ subjects will be evaluated at approximately three months follow up with questionnaires.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~subjects will be evaluated at approximately three months follow up with questionnaires.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Arterial spin labeling scan in Active and Waitlist Groups
Arterial spin labeling scan in all groups
Blood Oxygen Level Dependent Imaging scan in Active and Waitlist Groups
+6 moreSecondary outcome measures
Connor Davidson Resilience Scale-25
Connor Davidson Resilience Scale-25 (CD-RISC)
Anxiety Disorders
+5 morefMRIVNS Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Healthy Controls: Group II and IIIExperimental Treatment2 Interventions
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.
Group II: Transcutaneous Auricular Vagal Nerve Stimulation Intervention Group Distressed Healthcare WorkersActive Control1 Intervention
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.
Group III: Waitlist Control Distressed Healthcare Workers Delayed TaVNS GroupActive Control1 Intervention
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.
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Who is running the clinical trial?
Thomas Jefferson UniversityLead Sponsor
445 Previous Clinical Trials
145,624 Total Patients Enrolled
Andrew B NewbergPrincipal InvestigatorDepartment of Integrative Medicine and Nutritional Sciences
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I feel very distressed, scoring at least a 6 out of 10, and have physical reactions to stressful memories.I am on medication that could affect my brain's blood flow, as decided by the study leader.You have a stressful job memory that causes physical reactions such as increased heart rate or skin conductance level.I have epilepsy.I am not taking any medications that could affect my brain, as confirmed by a doctor.My current medications and supplements have been stable for at least 3 months.My other health issues, like high blood pressure or diabetes, are well-controlled and shouldn't affect my brain's blood flow.I have had brain surgery or conditions that could affect brain scan results.I do not have any major neurological or psychological conditions.I can understand and am willing to sign the consent form.I am of childbearing age and have a negative pregnancy test.I have jaw joint issues, facial paralysis, nerve problems in my face, or facial pain.I have a history of seizures.I am a health care worker over 21 years old.My doctor has not identified any conditions that could affect my brain's blood flow.I cannot stay still in a scanner due to claustrophobia or weight.You have memories that make your heart rate and skin conductance level increase, causing distress.You have a distress level of 6 or higher on a scale from 1 to 10.You are a healthcare worker who has reported feeling job-related distress and scored 6 or higher on a scale of 1 to 10.
Research Study Groups:
This trial has the following groups:- Group 1: Transcutaneous Auricular Vagal Nerve Stimulation Intervention Group Distressed Healthcare Workers
- Group 2: Healthy Controls: Group II and III
- Group 3: Waitlist Control Distressed Healthcare Workers Delayed TaVNS Group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Anxiety Patient Testimony for trial: Trial Name: NCT05132881 — N/A
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Can new participants still enroll in this research endeavor?
"The clinical trial is actively seeking participants, as evidenced by the information found on clinicialtrials.gov. This study was initially published on April 1st 2021, and its details were last revised on April 29th 2022."
Answered by AI
What goals is this experiment striving to accomplish?
"The primary outcome monitored over 90 days of this clinical trial is an assessment of Heart Rate Variability. Secondary objectives include measuring levels of General Anxiety Disorder (GAD-7) through a range from 0 to 21, Global Severity Index of the Brief Symptom Inventory-18 (BSI 18) which ranges from 1-5 and Insomnia Severity Index (ISI), rated 0-28 with higher scores representing more difficulties sleeping."
Answered by AI
What is the aggregate number of research participants enrolled in this trial?
"Affirmative. The clinicaltrials.gov website displays that this experiment is actively recruiting, having been initially posted on April 1st 2021 and last updated on April 29th 2022. 90 individuals will be included at a single facility for the investigation."
Answered by AI
Who else is applying?
What state do they live in?
Pennsylvania
What site did they apply to?
Thomas Jefferson University, Marcus Institute of Integrative Health Centers
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
1
3+
0
What questions have other patients asked about this trial?
How long do visits take and is there compensation?
PatientReceived no prior treatments
Why did patients apply to this trial?
I saw it on Power. I was contacted by you indicating i may be a candidate.
PatientReceived no prior treatments
I was contacted by Power Trials and I have anxiety & emotional distress.
PatientReceived 1 prior treatment
How responsive is this trial?
Typically responds via
Email
Most responsive sites:
- Thomas Jefferson University, Marcus Institute of Integrative Health Centers: < 48 hours
Average response time
- < 2 Days
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