NCT05372523

Senseye's OBCI Diagnostic Tool for PTSD

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

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 61 (actual)
• Sponsor: Senseye, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• PTSD

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	CAPS-5 Assessment	A validated, semi-structured clinical interview to assess core PTSD symptoms
DIAGNOSTIC_TEST	Senseye 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.

Timeline

• Start date: 2022-04-25
• Primary completion: 2023-01-11
• Completion: 2023-01-11
• First posted: 2022-05-12
• Last updated: 2023-04-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study