NCT06574971

Brief Summary

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2024

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 15, 2024

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

August 26, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 28, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2024

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2025

Completed
Last Updated

August 28, 2024

Status Verified

August 1, 2024

Enrollment Period

2 months

First QC Date

August 26, 2024

Last Update Submit

August 26, 2024

Conditions

Anxiety Disorders

Keywords

Anxiety disorderslow intensity focused ultrasoundauricular nervevagus nerve

Outcome Measures

Primary Outcomes (1)

  • Becks Anxiety Inventory

    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.

    From enrollment to the end of treatment at 4 weeks

Secondary Outcomes (3)

  • Pittsburg Sleep Quality Index

    From enrollment to the end of treatment at 4 weeks

  • Becks Depression Inventory

    From enrollment to the end of treatment at 4 weeks

  • PTSD Checklist for DSM-5

    From enrollment to the end of treatment at 4 weeks

Study Arms (1)

Primary arm

EXPERIMENTAL

All participants in the study we receive the intervention

Device: Low intensity focused ultrasound using the NeurGear Zenbud

Interventions

Low intensity focused ultrasound using the NeurGear ZenbudDEVICE

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

Primary arm

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NeurGear

Rochester, New York, 14618, United States

Location

Related Publications (1)

  • Johnson RL, Wilson CG. A review of vagus nerve stimulation as a therapeutic intervention. J Inflamm Res. 2018 May 16;11:203-213. doi: 10.2147/JIR.S163248. eCollection 2018.

    PMID: 29844694BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief Science Officer

Study Record Dates

First Submitted

August 26, 2024

First Posted

August 28, 2024

Study Start

August 15, 2024

Primary Completion

October 15, 2024

Study Completion

August 15, 2025

Last Updated

August 28, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)