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)

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.

Study Overview

• Status: Terminated
• Conditions: PTSD
• Intervention / Treatment: Diagnostic test: CAPS-5 Assessment; Diagnostic test: Senseye OBCI

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.

• Study Type: Observational
• Enrollment (Actual): 61

Contacts and Locations

Study Locations

• United States
  • California
    • Sylmar, California, United States, 91342
      • Olive View - UCLA Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Adults presenting to the clinic with potential psychiatric disorder, to include PTSD

Description

Inclusion Criteria:

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

Exclusion Criteria:

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.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Trauma+ & PTSD; Patients diagnosed with significant trauma exposure and PTSD	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.
Trauma+ & No PTSD; Patients diagnosed with significant trauma exposure but no PTSD	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.
No trauma or PTSD; Healthy adults without known major psychiatric disorders	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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Senseye, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): April 25, 2022
• Primary Completion (Actual): January 11, 2023
• Study Completion (Actual): January 11, 2023

Study Registration Dates

• First Submitted: April 27, 2022
• First Submitted That Met QC Criteria: May 10, 2022
• First Posted (Actual): May 12, 2022

Study Record Updates

• Last Update Posted (Actual): April 12, 2023
• Last Update Submitted That Met QC Criteria: April 10, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: SEN-01-2022

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No