NeurGear ZenBud System for Anxiety Disorders

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: NeurGear

Disqualifiers: Cancer, Pacemaker, Vagotomy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

30 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It might be best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the NeurGear ZenBud System treatment for anxiety disorders?

The research suggests that treatments combining cognitive-behavioral therapy (CBT) and technology, like virtual reality or computer-delivered programs, can effectively reduce anxiety symptoms. These approaches, similar to the NeurGear ZenBud System, have shown promise in helping people manage anxiety by providing accessible and engaging therapeutic experiences. ^{1 2 3 4 5}

How does the NeurGear ZenBud System treatment for anxiety disorders differ from other treatments?

The NeurGear ZenBud System is unique because it likely combines elements of biofeedback and virtual reality, offering a novel approach to anxiety treatment by providing immersive relaxation and exposure experiences, potentially even in outpatient settings through mobile devices. This differs from traditional medication or therapy by integrating technology to enhance treatment accessibility and engagement. ^{3 6 7 8 9}

What is the purpose of this trial?

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

This trial is for adults over 18 who score at least 28 on the Beck's Anxiety Inventory, indicating they have anxiety. They must be able to follow daily treatments and weekly assessments, communicate in English, and consent independently.

Inclusion Criteria

My anxiety score is 28 or higher on Beck's scale.

I can understand and agree to the study on my own.

I can follow the daily treatment plan and attend weekly check-ups.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use the ZenBud device for 5 minutes a day, every day for 4 weeks and complete weekly questionnaires

4 weeks

Weekly virtual check-ins

Follow-up

Participants complete a post-study survey asking questions about subjective efficacy and quality of life improvements

4 weeks

Treatment Details

Interventions

• NeurGear ZenBud System

Trial Overview The study tests if a wearable device called ZenBud can reduce anxiety symptoms by delivering low intensity focused ultrasound to a nerve near the ear. Participants use it for 5 minutes daily over four weeks while their anxiety, sleep quality, depression levels are monitored.

Participant Groups

Group I: Primary arm Experimental Treatment 1 Intervention

All participants in the study we receive the intervention

Who Is Running the Clinical Trial?

NeurGear

Lead Sponsor

Trials

1

Recruited

30+

Findings from Research

Selective serotonin reuptake inhibitors (SSRIs) remain the first-line treatment for generalized anxiety disorder (GAD), with alternatives like duloxetine and buspirone also recommended for initial treatment.

The updated algorithm considers special patient populations and includes a wider range of options for treatment-resistant cases, such as benzodiazepines and second-generation antipsychotics, reflecting new evidence and treatment developments from 2008 to 2014.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Psychopharmacology Algorithm Project at the Harvard South Shore Program: An Algorithm for Generalized Anxiety Disorder. Abejuela, HR., Osser, DN.[2018]

In a pilot study with 10 older adults, adding modular cognitive-behavioral therapy (mCBT) to the SSRI escitalopram significantly reduced anxiety symptoms, leading to full remission in most participants.

Some patients maintained their improvement even after stopping both the medication and therapy, suggesting that mCBT may provide lasting benefits beyond the treatment period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Augmenting antidepressant medication with modular CBT for geriatric generalized anxiety disorder: a pilot study. Wetherell, JL., Stoddard, JA., White, KS., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

The Psychopharmacology Algorithm Project at the Harvard South Shore Program: An Algorithm for Generalized Anxiety Disorder. [2018]

2. England pubmed.ncbi.nlm.nih.gov

Combining computerized home-based treatments for generalized anxiety disorder: an attention modification program and cognitive behavioral therapy. [2023]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Virtual reality in the treatment of generalized anxiety disorders. [2018]

4. Netherlands pubmed.ncbi.nlm.nih.gov

A Single-blinded, Randomized Clinical Trial of How to Implement an Evidence-based Treatment for Generalized Anxiety Disorder [IMPLEMENT]--Effects of Three Different Strategies of Implementation. [2018]

5. England pubmed.ncbi.nlm.nih.gov

Augmenting antidepressant medication with modular CBT for geriatric generalized anxiety disorder: a pilot study. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

An open trial of nefazodone in adult patients with generalized anxiety disorder. [2018]

7. England pubmed.ncbi.nlm.nih.gov

A randomized controlled trial of a smartphone-based application for the treatment of anxiety. [2022]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Quetiapine as an adjunctive pharmacotherapy for the treatment of non-remitting generalized anxiety disorder: a flexible-dose, open-label pilot trial. [2015]

9. United States pubmed.ncbi.nlm.nih.gov

Pilot open-label study of nefazodone in panic disorder. [2018]