Pilot Investigation of Senseye's Ocular Brain-Computer Interface (OBCI) for Diagnosis of Adult With Post-Traumatic Stress Disorder (PTSD)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 61
- 试验地点
- 1
- 主要终点
- Feasibility of the Senseye tool
研究概览
简要总结
This pilot study will investigate the feasibility, acceptability, repeatability, accuracy and efficacy of the Senseye OBCI diagnostic tool to assess the presence and severity of PTSD symptoms and monitor response to trauma-informed interventions. A total of 68 adults will be included in the study with a follow-up time point of 9 weeks post-initial intervention.
详细描述
This pilot study will investigate the feasibility, acceptability, repeatability, accuracy, and efficacy of operator-independent Senseye Ocular Brain-Computer Interface (OBCI) diagnostic tool to assess the presence and severity of PTSD symptoms and monitor response to trauma-informed interventions. After informed consent, 68 adults - 34 with PTSD and 17 adults with significant trauma exposure but no PTSD, and 17 healthy adults without known major psychiatric disorders, aged 18-65 years old, will be recruited and undergo OBCI diagnostic tool, comparing against gold standards tools- the CAPS-5, UCLA PTSD Reaction Index for DSM-5 (PTSD-RI). Fifteen participants will undergo repeatability and reproducibility assessments. Adults with PTSD will receive a standard of care trauma-informed interventions for eight weeks, and their biopsychosocial characteristics, Senseye OBCI, neuropsychiatric measures will be measured at baseline and week 9. Using Senseye's machine learning algorithm, Senseye OBCI will use a facecam recorder during a series of visual tasks, pupil light reflex, and heart rate measurement throughout.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male/Female diagnosed with PTSD (only for PTSD group)
- •aged 18- 65 years old
- •able to read/write in English
排除标准
- •presence of intellectual disabilities
- •psychotic or self-injurious behavior
- •seizure disorder
- •major depression
- •traumatic brain injury (TBI)
- •language disorder
- •eye disorders
- •other neurodevelopmental disorders
- •history of lifetime psychosis
- •current suicidality
- •diagnosis of a substance use disorder
- •impaired functioning to the degree that requires immediate initiation of psychotropic medication.
结局指标
主要结局
Feasibility of the Senseye tool
时间窗: 9 weeks
Feasibility will be assessed by evaluating retention rate.
Agreement between Senseye OBCI measures and gold-standard measures
时间窗: 9 weeks
Assessments for the presence and severity of PTSD symptoms will be compared between the Senseye tool and the gold-standard measures for percent agreement.
Test-retest for repeatability of the Senseye tool
时间窗: 1 week
Senseye OBCI assessments will be repeated the same day and again at one week.
次要结局
- Prognostic value by comparing Senseye OBCI to core PTSD symptoms(9 weeks)
