Pre-Post Intervention Study to Investigate the Safety, Feasibility, & Efficacy of the NeurGear ZenBud System for the Treatment of Anxiety & Anxiety-Related Symptoms
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Becks Anxiety Inventory
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Becks Anxiety Inventory
时间窗: 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.
次要结局
- Pittsburg Sleep Quality Index(From enrollment to the end of treatment at 4 weeks)
- Becks Depression Inventory(From enrollment to the end of treatment at 4 weeks)
- PTSD Checklist for DSM-5(From enrollment to the end of treatment at 4 weeks)
研究者
Izzy Kohler
Chief Science Officer
NeurGear