Last reviewed · How we verify
NCT06574971
Pre-Post Intervention Study to Investigate the Safety, Feasibility, & Efficacy of the NeurGear ZenBud System for the Treatment of Anxiety & Anxiety-Related Symptoms
NA trial testing Low intensity focused ultrasound using the NeurGear Zenbud in Anxiety Disorders in 30 participants. Participants enrolled and being followed up; not accepting new ones.
15 October 2024
Quick facts
| Lead sponsor | NeurGear |
|---|---|
| Phase | NA |
| Status | Active, enrolled |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 30 |
| Start date | 15 August 2024 |
| Primary completion | 15 October 2024 |
| Estimated completion | 15 August 2025 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Low intensity focused ultrasound using the NeurGear Zenbud
Conditions studied
- Anxiety Disorders — all drugs for Anxiety Disorders →
Sponsor
NeurGear
Who can join
21 and older, any sex, with Anxiety Disorders. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Reduction of Anxiety-Related Symptoms Using Low-Intensity Ultrasound Neuromodulation on the Auricular Branch of the Vagus Nerve: Preliminary Study.
Kohler I, Hacker J, Martin E. · · 2025 · PMID 41341418 · DOI 10.2196/69770
Verify or expand the search:
- PubMed search for NCT06574971
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06574971 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by NeurGear
- Last refreshed: 28 August 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06574971.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing