What side effects are associated with this type of intervention?

Common treatments for anxiety that are similar to Transauricular Vagal Nerve Stimulation (TaVNS) include various forms of neuromodulation such as noninvasive vagus nerve stimulation (nVNS) and transcranial magnetic stimulation (TMS). The known side effects of these treatments are generally mild and may include sensations such as warmth, tingling, redness, itching, and muscle spasms. More specific to nVNS, side effects can also include arm or hand numbness, shoulder pain, and neck pain. Serious adverse events are rare. For broader anxiety treatments, side effects can vary widely depending on the specific medication or therapy used, but common ones include dizziness, headaches, gastrointestinal issues, and sleep disturbances.

What prior FDA approvals exist?

The FDA has approved several treatments for anxiety, including pharmacological agents and neuromodulation techniques. Pharmacological treatments include selective serotonin reuptake inhibitors (SSRIs) like sertraline and fluoxetine, serotonin-norepinephrine reuptake inhibitors (SNRIs) like venlafaxine, and benzodiazepines like alprazolam. In terms of neuromodulation, the FDA has approved devices such as transcranial magnetic stimulation (TMS) for depression, which may also have applications in anxiety treatment. While TaVNS specifically is still under investigation, vagus nerve stimulation (VNS) has been approved for treatment-resistant depression and epilepsy, indicating a potential pathway for future anxiety treatments.

What other types of research exist?

Promising novel alternatives to TaVNS for anxiety treatment in 2024 include: 1) Repetitive Transcranial Magnetic Stimulation (rTMS), which has shown efficacy in altering cortical excitability and reducing symptoms of anxiety and depression. 2) Transcranial Direct Current Stimulation (tDCS), a non-invasive method that modulates neuronal activity and has been studied for its anxiolytic effects. 3) Deep Brain Stimulation (DBS), though more invasive, has been explored for treatment-resistant anxiety disorders. 4) Neurofeedback, which trains individuals to alter their brain activity through real-time feedback and has shown promise in reducing anxiety symptoms.

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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

Must not have

Epilepsy

Previous brain surgery or intracranial abnormalities that may complicate interpretation of the brain scans (e.g., stroke, tumor, vascular abnormality)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up subjects will be evaluated at baseline and approximately six months follow up with questionnaires.

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to see if a device that sends mild electrical signals to the ears can reduce stress and anxiety in healthcare workers. Researchers will use brain scans to observe changes in brain activity while using the device. The study focuses on healthcare workers in Philadelphia who are experiencing high levels of distress. This method has been researched and applied as a non-invasive treatment for various conditions over the past two decades.

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I feel very distressed, scoring at least a 6 out of 10, and have physical reactions to stressful memories.

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I do not have any major neurological or psychological conditions.

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I am of childbearing age and have a negative pregnancy test.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have epilepsy.

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I have had brain surgery or conditions that could affect brain scan results.

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I have a history of seizures.

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I cannot stay still in a scanner due to claustrophobia or weight.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ subjects will be evaluated approximately six months follow up with questionnaires.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~subjects will be evaluated approximately six months follow up with questionnaires.

This trial's timeline: 3 weeks for screening, Varies for treatment, and subjects will be evaluated approximately six months follow up with questionnaires. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 more

Secondary study objectives

Connor Davidson Resilience Scale-25

Connor Davidson Resilience Scale-25 (CD-RISC)

Anxiety Disorders

+5 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 7Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Transauricular Vagal Nerve Stimulation (TaVNS) works by stimulating the vagus nerve through the ear, which can reduce distress and alter brain activity, potentially leading to decreased anxiety. This method leverages the vagus nerve's role in the parasympathetic nervous system to promote a 'rest and digest' response, counteracting the 'fight or flight' response associated with anxiety. Other common treatments for anxiety include cognitive-behavioral therapy (CBT), which aims to change negative thought patterns and behaviors, and medications like selective serotonin reuptake inhibitors (SSRIs), which increase serotonin levels in the brain to improve mood. Understanding these mechanisms is crucial for anxiety patients as it helps them and their healthcare providers choose the most appropriate treatment based on how it works and its potential benefits.

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