Status:
ACTIVE_NOT_RECRUITING
Pre-Post Intervention Study to Investigate the Safety, Feasibility, & Efficacy of the NeurGear ZenBud System for the Treatment of Anxiety & Anxiety-Related Symptoms
Lead Sponsor:
NeurGear
Conditions:
Anxiety Disorders
Eligibility:
All Genders
21+ years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
August 15 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 15 2025
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06574971
Start Date
August 15 2024
End Date
August 15 2025
Last Update
August 28 2024
Active Locations (1)
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1
NeurGear
Rochester, New York, United States, 14618