Senseye's OBCI Diagnostic Tool for PTSD

Terminated

• Conditions: PTSD
• Interventions: Diagnostic Test: CAPS-5 Assessment; Diagnostic Test: Senseye OBCI

• Registration Number: NCT05372523
• Lead Sponsor: Senseye, Inc.

Brief 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.

Study Timeline

• Study Start: 2022-04-25
• Study First Submitted: 2022-04-27
• Study First Submitted QC: 2022-05-10
• Study First Posted: 2022-05-12
• Primary Completion: 2023-01-11
• Study Completion: 2023-01-11
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-10
• Last Update Posted: 2023-04-12

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 61

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Trauma+ & No PTSD	CAPS-5 Assessment	Patients diagnosed with significant trauma exposure but no PTSD
Trauma+ & No PTSD	Senseye OBCI	Patients diagnosed with significant trauma exposure but no PTSD
No trauma or PTSD	CAPS-5 Assessment	Healthy adults without known major psychiatric disorders
No trauma or PTSD	Senseye OBCI	Healthy adults without known major psychiatric disorders
Trauma+ & PTSD	CAPS-5 Assessment	Patients diagnosed with significant trauma exposure and PTSD
Trauma+ & PTSD	Senseye OBCI	Patients diagnosed with significant trauma exposure and PTSD

Primary Outcome Measures

Name	Time	Method
Feasibility of the Senseye tool	9 weeks	Feasibility will be assessed by evaluating retention rate.
Agreement between Senseye OBCI measures and gold-standard measures	9 weeks	Assessments for the presence and severity of PTSD symptoms will be compared between the Senseye tool and the gold-standard measures for percent agreement.
Test-retest for repeatability of the Senseye tool	1 week	Senseye OBCI assessments will be repeated the same day and again at one week.

Secondary Outcome Measures

Name	Time	Method
Prognostic value by comparing Senseye OBCI to core PTSD symptoms	9 weeks	Analyses of data collected on the Senseye tool will be compared with the core PTSD symptoms.

Trial Locations

Locations (1)

Olive View - UCLA Medical Center; 🇺🇸 Sylmar, California, United States