Pre-Post Intervention Study to Investigate the Safety, Feasibility, & Efficacy of the NeurGear ZenBud System for the Treatment of Anxiety & Anxiety-Related Symptoms

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-15

Study Completion Date

2025-08-15

Brief Summary

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The goal of this clinical trial is to learn if low intensity fodused ultrasound stiulation delivered to the auricular branch of the vagus nerve works to mitigate symptoms of anxiety disorder in adults. It will also learn about the safety and feasibility of low intensity focused ultrasound stimulation. The main questions it aims to answer are:

Is low intensity ultrasound applied to the auricular branch of the vagus nerve effective for reducing the symptoms of anxiety disorders?

Is low intensity ultrasound applied to the auricular branch of the vagus nerve effective for improving quality of life and sleep for individuals who suffer from anxiety disorders?

Is low intensity ultrasound applied to the auricular branch of the vagus nerve effective for reducing the symptoms of depression for individuals who suffer from anxiety disorders?

Is the Neurgear Zenbud a safe, accessible, and feasible way of treatment for individuals who suffer from anxiety disorders?

Participants will:

Use the ZenBud device, a wearable low intensity focused ultrasound delivery device, for 5 minutes a day, every day for 4 weeks

Complete a weekly Becks Anxiety Inventory, Becks, Depression Inventory, Pittsburgh Sleep Quality Index questionnaire, and PCL-5 weekly

Complete a post study survey asking questions about subjective efficacy and quality of life improvements.

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Detailed Description

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Conditions

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Anxiety Disorders

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Primary arm

All participants in the study we receive the intervention

Group Type EXPERIMENTAL

Low intensity focused ultrasound using the NeurGear Zenbud

Intervention Type DEVICE

The NeurGear Zenbud is a wearable earbud that delivers low intensity focused ultrasound to the auricular branch of the vagus nerve

Interventions

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Low intensity focused ultrasound using the NeurGear Zenbud

The NeurGear Zenbud is a wearable earbud that delivers low intensity focused ultrasound to the auricular branch of the vagus nerve

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Scoring ≥ 28 on the Beck's Anxiety Inventory
2. Age 18 or older.
3. Ability to independently provide informed consent.
4. Ability to comply with the daily treatment and weekly assessments
5. Ability to communicate in English.

Exclusion Criteria

1. Scoring below the aforementioned cutoff on the BAI
2. Inability to comply with the treatment and assessment protocol
3. Age less than 18 years.
4. Inability to provide informed consent.
5. Conditions for which ultrasound is contraindicated including cancer, pacemaker, and impaired sensory sensitivity.
6. Conditions for which vagus nerve stimulation is contraindicated including history of vagotomy.

Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No