Impact of Peripheral Sensory Stimulation of the Hand and Synchronized Deep Breathing in the Treatment of Post-Traumatic Stress Disorder: Assessing Safety and Effectiveness
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Portion of participants with adverse events
研究概览
简要总结
This is a prospective, home-based, interventional clinical study in which 6 subjects will be enrolled. Six (6) subjects who suffer from post-traumatic stress disorder will receive treatment using the NeuroGlove.
详细描述
This is a prospective, home-based, interventional clinical study in which 6 subjects will be enrolled. Six (6) subjects who suffer from post-traumatic stress disorder will receive treatment using the NeuroGlove.
There will be a single cohort in the study consisting of the subjects with PTSD who will receive treatment with NeuroGlove.
The trial is intended to evaluate the impact of the device use on active PTSD symptoms and subject sense of well-being.
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
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able to and willing to provide informed consent. Legally authorized representatives (LARs) will not be allowed to consent on behalf of the subject.
- •Men and women ≥18 and <85 years of age.
- •Carry an active diagnosis of PTSD.
- •Suffer from PTSD symptoms that impact subject's daily activities and quality of life.
排除标准
- •Physical limitations of the upper extremity (e.g., fracture, joint deformity, severe spasticity/contracture, wounds, skin breakdown, lymphedema, etc.)
- •Subject lacks the ability to comprehend or following instructions, or for any reason, in the opinion of the investigator, would be unlikely or unable to comply with study protocol requirements.
- •Currently participating in another interventional clinical trial. (Observational clinical trial participation is allowed for study enrollment.)
结局指标
主要结局
Portion of participants with adverse events
时间窗: 4 weeks
Rate and severity of adverse events related to the use of the NeuroGlove.
PTSD Symptom Reduction
时间窗: 4 weeks
Change in PTSD symptoms and subject's sense of well-being
次要结局
- PTSD Symptom Severity(4 weeks)