Clinical trial NCT06574971: Pre-Post Intervention Study to Investigate the Safety, Feasibility, & Efficacy of the NeurGear ZenBud System for the Treatment of Anxiety & Anxiety-Related Symptoms
Official title: Pre-Post Intervention Study to Investigate the Safety, Feasibility, & Efficacy of the NeurGear ZenBud System for the Treatment of Anxiety & Anxiety-Related Symptoms
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Anxiety Disorders
Keywords: Anxiety disorders
low intensity focused ultrasound
auricular nerve
vagus nerve
Lead sponsor: NeurGear
Sponsor class: INDUSTRY
First posted: 2024-08-28
Enrollment: 30
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Becks Anxiety Inventory
timeFrame: From enrollment to the end of treatment at 4 weeks
Secondary outcomes:
measure: Pittsburg Sleep Quality Index
timeFrame: From enrollment to the end of treatment at 4 weeks
measure: Becks Depression Inventory
timeFrame: From enrollment to the end of treatment at 4 weeks
measure: PTSD Checklist for DSM-5
timeFrame: From enrollment to the end of treatment at 4 weeks
Other outcomes:
Locations:
city: Rochester
country: United States
facility: NeurGear
state: New York
Study officials:
References:
citation: 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.