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NCT Number: NCT06574971

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Anxiety Disorders Mental Disorders

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NeurGear

Rochester, New York, 14618, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Low intensity focused ultrasound using the NeurGear Zenbud

Device

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

Primary outcomes

  1. Becks Anxiety Inventory

    Time frame: From enrollment to the end of treatment at 4 weeks

    The Beck Anxiety Inventory (BAI) is a 21-question self-report inventory that measures anxiety levels in adults and adolescents. It was written by Aaron T. Beck, M.D., and R.A. Steer. The BAI is used to assess the intensity of physical and cognitive anxiety symptoms during the past week.

Secondary outcomes

  1. Pittsburg Sleep Quality Index

    Time frame: From enrollment to the end of treatment at 4 weeks

    The Pittsburgh Sleep Quality Index (PSQI) is a 19-question questionnaire that assesses sleep quality and disturbances over a one-month period. It's designed for clinical populations and is valid and has acceptable psychometric properties when used in men and non-pregnant women in diverse global settings.

  2. Becks Depression Inventory

    Time frame: From enrollment to the end of treatment at 4 weeks

    The Beck Depression Inventory (BDI) is a 21-item self-report questionnaire that assesses the level of depression in adults. The BDI measures both cognitive and physical symptoms of depression, such as sadness, pessimism, and worthlessness. It generates a single score that indicates the severity of depression as minimal, mild, moderate, or severe. The individual scale items are scored on a 4-point continuum, with a total summed score range of 0-63. Higher scores indicate greater depressive severity.

  3. PTSD Checklist for DSM-5

    Time frame: From enrollment to the end of treatment at 4 weeks

    The Post-Traumatic Stress Disorder (PTSD) Checklist for DSM-5 (PCL-5) is a 20-item self-report tool that assesses the 20 symptoms of PTSD in adults. It's designed for people who have experienced traumatic events. The PCL-5 can help with: Monitoring symptom changes during and after treatment, Screening people for PTSD, and Making provisional PTSD diagnoses

Sponsors and collaborators

Lead sponsor

NeurGear

Industry

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Aug 28, 2024
Registry last updated
Aug 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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