Summary

Eligibility
for people ages 18-65 (full criteria)
Healthy Volunteers
healthy people welcome
Location
at UCLA
Dates
study started
estimated completion
Principal Investigator
by Naser Ahmadi, MD (ucla)
Headshot of Naser Ahmadi
Naser Ahmadi

Description

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.

Official Title

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

Details

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.

Keywords

PTSD CAPS-5 Assessment Senseye OBCI

Eligibility

You can join if…

Open to people ages 18-65

  1. Male/Female diagnosed with PTSD (only for PTSD group)
  2. aged 18- 65 years old
  3. able to read/write in English

You CAN'T join if...

  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.

Location

  • Olive View - UCLA Medical Center accepting new patients
    Sylmar California 91342 United States

Lead Scientist at University of California Health

  • Naser Ahmadi, MD (ucla)
    HS Assistant Clinical Professor, Psychiatry and Biobehavioral Sciences, Medicine. Authored (or co-authored) 72 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Senseye, Inc.
ID
NCT05372523
Study Type
Observational
Participants
Expecting 68 study participants
Last Updated