NCT04751864进行中（未招募）4 期
Fisher Wallace Brain Stimulation & Generalized Anxiety Study
适应症
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 发起方
- ProofPilot
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Change in Beck Anxiety Inventory (BAI) Score
研究概览
简要总结
Examine the safety and effectiveness of the Fisher Wallace Cranial Electrotherapy Stimulator (CES) Device on Generalized Anxiety Disorder using two (2) 20-minute per day treatment sessions over eight weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age greater than 21
- •US resident
- •Can receive packages to their home via UPS/Fedex/USPS
- •Licensed Physician Diagnosis of Generalized Anxiety Disorder
- •Beck Anxiety Inventory Score between 8 and 25
- •Read/write English
- •Have not contemplated suicide in the past year
- •Not been institutionalized for mental health issues.
- •Not currently experiencing problems with alcohol or drug abuse
- •Can commit to not drinking alcohol 4 hours before bedtime for the duration of the study
- •Can commit to two (2) 20 minute sessions per day for 8 weeks
- •Not under medical supervision for serious medical condition
- •Not currently being treated for or suspect a mental health issue
- •Has not used a brain stimulation treatment in one year
- •No suspected or known history of heart disease
- •No pacemaker, or any form of medical electronics, including but not limited to a deep - brain stimulator, electronic stent, etc.
- •Not taking opioids
- •Are a resident of states in which we have licensed medical professionals
- •Does not have any co-occurring significant psychiatric disorder that would impair - participant's particationion.
- •Does not use any illicit drugs
- •Not participating in any other anxiety study
- •Not taking medications affecting the nervous system (e.g. psychiatric medications)
- •Not taking hypnotics or any sleep aid or marijuana (in any form)
排除标准
- 未提供
结局指标
主要结局
Change in Beck Anxiety Inventory (BAI) Score
时间窗: baseline versus week 4
The Beck is a 21 item self-reported scale measuring anxiety
次要结局
- Device safety, tolerability and adherence as measured by SAFTEE(baseline versus week 8)
- Change in Promise Sleep-SD(baseline versus week 4)
- Change in Beck Anxiety Inventory (BAI) Score(week 4 versus week 8)
- Change in Patient Health Questionnaire - 8 (PHQ-8)(baseline versus week 4)
研究者
研究点 (1)
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