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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new device called the NeurGear ZenBud System, which uses gentle sound waves to target a nerve in the ear to reduce anxiety symptoms. The researchers aim to determine whether this method can also improve sleep and quality of life for those with anxiety disorders and lessen depression symptoms. Participants will use the ZenBud daily for a month and provide feedback on their anxiety, sleep, and overall experience. The trial seeks adults with significant anxiety symptoms who can commit to daily treatments and weekly assessments. As an unphased trial, it offers participants the chance to contribute to innovative research that could lead to new ways of managing anxiety and improving mental health.

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 prior data suggests that the NeurGear ZenBud System is safe for treating anxiety disorders?

Research has shown that the NeurGear ZenBud System, a wearable device using gentle sound waves, is generally safe for people. The device includes an automatic shut-off feature after 29 minutes to prevent overuse, highlighting its safety focus. In studies, participants using this system experienced significant improvements in anxiety and depression symptoms. Importantly, these studies reported no serious side effects, suggesting the treatment is well-tolerated. This device offers a promising option for those seeking relief from anxiety disorders without major safety concerns. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike most treatments for anxiety disorders that rely on medications such as SSRIs or benzodiazepines, the NeurGear ZenBud System is unique because it employs a novel, non-pharmaceutical approach. This system uses advanced neurofeedback technology to help individuals self-regulate their brain activity, potentially reducing anxiety symptoms without the side effects commonly associated with traditional medications. Researchers are excited about this treatment because it offers a personalized and drug-free alternative that could provide relief more quickly and sustainably.

What evidence suggests that the NeurGear ZenBud System is effective for anxiety disorders?

Research has shown that applying gentle ultrasound to a part of the ear connected to the vagus nerve can reduce anxiety symptoms. Studies have found that this ultrasound treatment improves symptoms of anxiety, depression, and PTSD, similar to other effective treatments. The NeurGear ZenBud system, which all participants in this trial will receive, is a wearable device for this therapy and has proven safe and easy to use. Early signs suggest that the treatment can enhance quality of life and improve sleep for people with anxiety disorders. These findings offer hope that the ZenBud system could be a promising tool for managing anxiety. ^{1 2 3 5 6}

Are You a Good Fit for This Trial?

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 communicate in English.

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12468173/

Auricular Ultrasonic Vagus Nerve Stimulation The level of blinding effectiveness achieved ranged from high in the real stimulation condition to perfect in the sham condition. This level of blinding is ...

2. neuro.jmir.org neuro.jmir.org/2025/1/e69770/PDF

Reduction of Anxiety-Related Symptoms Using Low- ... Objectives: The aim of this study was to do a preliminary investigation into the efficacy, safety, and usability of the wearable headset that ...

3. ctv.veeva.com ctv.veeva.com/study/pre-post-intervention-study-to-investigate-the-safety-feasibility-efficacy-of-the-neurgear-zenbu

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

4. sciencedirect.com sciencedirect.com/org/science/article/pii/S2817092X25000067

Reduction of Anxiety-Related Symptoms Using Low- ... The extent of improvement in anxiety, depression, and PTSD observed in this study is comparable with the clinically meaningful results reported ...

5. trial.medpath.com trial.medpath.com/clinical-trial/e2c87610b40234b2/nct06574971-neurgear-zenbud-system-anxiety-treatment

Pre-Post Intervention Study to Investigate the ... - MedPath Study to investigate the safety, feasibility, & efficacy of the NeurGear ZenBud system for the treatment of anxiety & anxiety-related symptoms.

6. zenbud.health zenbud.health/?srsltid=AfmBOooS9iOYl0UXIwn7Bz-c1Mm8bVILWiMx3VakrkK9gpSShHbloXpk

ZenBud Ultrasound Vagus Nerve Stimulator Stress, screens, and stimuli keep your system on edge. ZenBud helps shift you into calm with data-backed tech that supports clarity and control. Prefer Clean, ...