Senseye's OBCI Diagnostic Tool for PTSD

PTSD Clinical Trial

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

Status Terminated

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• PTSD

• NCT number: NCT05372523
• Study type: Observational
• Source: Senseye, Inc.
• Status: Terminated
• Start date: April 25, 2022
• Completion date: January 11, 2023