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

NeurGear

Status: Active, not recruiting

Conditions: Anxiety Disorders

Study type: Interventional

Funder types: Industry

Identifiers

NCT06574971

1360094

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)