Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
No participants completed study
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Trauma+ & PTSD | Patients diagnosed with significant trauma exposure and PTSD |
| |
| Trauma+ & No PTSD | Patients diagnosed with significant trauma exposure but no PTSD |
| |
| No trauma or PTSD | Healthy adults without known major psychiatric disorders |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CAPS-5 Assessment | Diagnostic Test | A validated, semi-structured clinical interview to assess core PTSD symptoms |
|
| 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 |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Adults presenting to the clinic with potential psychiatric disorder, to include PTSD
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Naser Ahmadi, MD | Olive View - UCLA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Olive View - UCLA Medical Center | Sylmar | California | 91342 | United States |
Not provided
| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
Not provided
Not provided
Not provided
| Senseye OBCI | Diagnostic Test | 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. |
|