Pilot Investigation of Senseye's Ocular Brain-Computer Interface (OBCI) for Diagnosis of Adult With Post-Traumatic Stress Disorder (PTSD)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- PTSD
- Sponsor
- Senseye, Inc.
- Enrollment
- 61
- Locations
- 1
- Primary Endpoint
- Feasibility of the Senseye tool
- Status
- Terminated
- Last Updated
- 3 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Male/Female diagnosed with PTSD (only for PTSD group)
- •aged 18- 65 years old
- •able to read/write in English
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Feasibility of the Senseye tool
Time Frame: 9 weeks
Feasibility will be assessed by evaluating retention rate.
Agreement between Senseye OBCI measures and gold-standard measures
Time Frame: 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
Time Frame: 1 week
Senseye OBCI assessments will be repeated the same day and again at one week.
Secondary Outcomes
- Prognostic value by comparing Senseye OBCI to core PTSD symptoms(9 weeks)