PTSD
Conditions
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.
Interventions
DIAGNOSTIC_TESTCAPS-5 Assessment
A validated, semi-structured clinical interview to assess core PTSD symptoms
DIAGNOSTIC_TESTSenseye OBCI
Using a machine learning algorithm, Senseye's DT will record a series of visual tasks, pupil light reflex, vascular function and heart rate measurement throughout.
Sponsors
Senseye, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
1. Male/Female diagnosed with PTSD (only for PTSD group) 2. aged 18- 65 years old 3. able to read/write in English
Exclusion criteria
1. presence of intellectual disabilities 2. psychotic or self-injurious behavior 3. seizure disorder 4. major depression 5. traumatic brain injury (TBI) 6. language disorder 7. eye disorders 8. other neurodevelopmental disorders 9. history of lifetime psychosis 10. mania 11. current suicidality 12. diagnosis of a substance use disorder 13. impaired functioning to the degree that requires immediate initiation of psychotropic medication.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Agreement between Senseye OBCI measures and gold-standard measures | 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. |
| Feasibility of the Senseye tool | 9 weeks | Feasibility will be assessed by evaluating retention rate. |
| Test-retest for repeatability of the Senseye tool | 1 week | Senseye OBCI assessments will be repeated the same day and again at one week. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Prognostic value by comparing Senseye OBCI to core PTSD symptoms | 9 weeks | Analyses of data collected on the Senseye tool will be compared with the core PTSD symptoms. |
Countries
United States
Outcome results
None listed