Anxiety DisordersNCT06574971
Pre-Post Intervention Study to Investigate the Safety, Feasibility, & Efficacy of the NeurGear ZenBud System for the Treatment of Anxiety & Anxiety-Related Symptoms
A study testing Low intensity focused ultrasound using the NeurGear Zenbud in people with Anxiety Disorders, run by NeurGear at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Anxiety Disorders
- What is being tested?
- Low intensity focused ultrasound using the NeurGear Zenbud
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Aug 2024to 15 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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?
Read more
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.
- Conditions
- Anxiety Disorders
- Being tested
- Low intensity focused ultrasound using the NeurGear Zenbud
- Keywords
- Anxiety disorders, low intensity focused ultrasound, auricular nerve, vagus nerve
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| Primary arm | Experimental | All participants in the study we receive the intervention Receives: Device: Low intensity focused ultrasound using the NeurGear Zenbud |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment to the end of treatment at 4 weeks
Secondary outcomes (3)
Pittsburg Sleep Quality Index
The Pittsburgh Sleep Quality Index (PSQI) is a 19-question questionnaire that assesses sleep quality and disturbances over a one-month period. It's designed for clinical populations and is valid and has acceptable psychometric properties when used in men and non-pregnant women in diverse global settings.
Measured: From enrollment to the end of treatment at 4 weeks
Becks Depression Inventory
The Beck Depression Inventory (BDI) is a 21-item self-report questionnaire that assesses the level of depression in adults. The BDI measures both cognitive and physical symptoms of depression, such as sadness, pessimism, and worthlessness. It generates a single score that indicates the severity of depression as minimal, mild, moderate, or severe. The individual scale items are scored on a 4-point continuum, with a total summed score range of 0-63. Higher scores indicate greater depressive severity.
Measured: From enrollment to the end of treatment at 4 weeks
PTSD Checklist for DSM-5
The Post-Traumatic Stress Disorder (PTSD) Checklist for DSM-5 (PCL-5) is a 20-item self-report tool that assesses the 20 symptoms of PTSD in adults. It's designed for people who have experienced traumatic events. The PCL-5 can help with: Monitoring symptom changes during and after treatment, Screening people for PTSD, and Making provisional PTSD diagnoses
Measured: From enrollment to the end of treatment at 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2024
- Study start15 Aug 2024
- Primary completion15 Oct 2024 (estimated)
- Study completion15 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anxiety DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NeurGear
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Izzy Kohler, NeurGear
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06574971
- Sponsor's protocol ID
- 1360094
- Status last verified
- Aug 2024
- First submitted
- 26 Aug 2024
- Last updated
- 28 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 29844694
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06574971
- Acronym / sponsor ID
- 1360094
- Conditions
- Anxiety Disorders
- Keywords
- Anxiety disorders, low intensity focused ultrasound, auricular nerve, vagus nerve
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- NeurGearIndustry (pharma, biotech, devices)
- Study start
- 15 Aug 2024 (actual)
- Primary completion
- 15 Oct 2024 (estimated)
- Study completion
- 15 Aug 2025 (estimated)
- First posted
- 28 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Primary arm | Experimental | Device: Low intensity focused ultrasound using the NeurGear ZenbudAll participants in the study we receive the intervention |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low intensity focused ultrasound using the NeurGear ZenbudThe NeurGear Zenbud is a wearable earbud that delivers low intensity focused ultrasound to the auricular branch of the vagus nerve | Device | Primary arm |
Primary outcome
Becks Anxiety Inventory
Time frame: From enrollment to the end of treatment at 4 weeks
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.
3 secondary outcomes
Pittsburg Sleep Quality Index
Time frame: From enrollment to the end of treatment at 4 weeks
Becks Depression Inventory
Time frame: From enrollment to the end of treatment at 4 weeks
PTSD Checklist for DSM-5
Time frame: From enrollment to the end of treatment at 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2024.
- Background: PubMed 29844694Johnson 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.
- Individual participant dataSharing planned: No
Related trials for Anxiety Disorders
Not yet recruiting
Building Resilience Through Anxiety Virtual Education in PICU Survivors
Critical Illness Recovery, Mental Health
Not yet recruiting
Mandala Coloring in Late Pregnancy
Pregnancy, Anxiety
Recruiting
Modulating Escape Using Focused Ultrasound
Anxiety Disorders
Not yet recruitingObservational study
Ecological Momentary Assessment of State-Dependent Decision-Making and Metacognition Across a Psychopathology Continuum
Depression, Anxiety
Recruiting
Stress and Anxiety Effects on Valuation
Reward Value Level
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low intensity focused ultrasound using the NeurGear Zenbud in people with Anxiety Disorders, run by NeurGear at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Becks Anxiety Inventory (time frame: From enrollment to the end of treatment at 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06574971, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2024.