Senseye's OBCI Diagnostic Tool for PTSD

Study Overview
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Brief Summary
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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
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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.

Official Title
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Pilot Investigation of Senseye's Ocular Brain-Computer Interface (OBCI) for Diagnosis of Adult With Post-Traumatic Stress Disorder (PTSD)

Conditions
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PTSD

Intervention / Treatment
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* Diagnostic Test: CAPS-5 Assessment
* Diagnostic Test: Senseye OBCI


Participation Criteria
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Eligibility Criteria
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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 mania current suicidality diagnosis of a substance use disorder impaired functioning to the degree that requires immediate initiation of psychotropic medication.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Trauma+ & PTSD<br>Patients diagnosed with significant trauma exposure and PTSD | Diagnostic Test: CAPS-5 Assessment<br>* A validated, semi-structured clinical interview to assess core PTSD symptoms<br>Diagnostic Test: Senseye OBCI<br>* 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.<br>|
| Trauma+ & No PTSD<br>Patients diagnosed with significant trauma exposure but no PTSD | Diagnostic Test: CAPS-5 Assessment<br>* A validated, semi-structured clinical interview to assess core PTSD symptoms<br>Diagnostic Test: Senseye OBCI<br>* 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.<br>|
| No trauma or PTSD<br>Healthy adults without known major psychiatric disorders | Diagnostic Test: CAPS-5 Assessment<br>* A validated, semi-structured clinical interview to assess core PTSD symptoms<br>Diagnostic Test: Senseye OBCI<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Agreement between Senseye OBCI measures and gold-standard measures | Assessments for the presence and severity of PTSD symptoms will be compared between the Senseye tool and the gold-standard measures for percent agreement. | 9 weeks | 
| Feasibility of the Senseye tool | Feasibility will be assessed by evaluating retention rate. | 9 weeks | 
| Test-retest for repeatability of the Senseye tool | Senseye OBCI assessments will be repeated the same day and again at one week. | 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prognostic value by comparing Senseye OBCI to core PTSD symptoms | Analyses of data collected on the Senseye tool will be compared with the core PTSD symptoms. | 9 weeks |