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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05372523
• Other study ID #: SEN-01-2022
• Status: Terminated
• Start date: April 25, 2022
• Est. completion date: January 11, 2023

Study information

• Verified date: April 2023
• Source: Senseye, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 61
• Est. completion date: January 11, 2023
• Est. primary completion date: January 11, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• PTSD

Intervention

Diagnostic Test:
• CAPS-5 Assessment
A validated, semi-structured clinical interview to assess core PTSD symptoms
• 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.

Locations

Country	Name	City	State
United States	Olive View - UCLA Medical Center	Sylmar	California

Sponsors (1)

Lead Sponsor	Collaborator
Senseye, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Feasibility of the Senseye tool	Feasibility will be assessed by evaluating retention rate.	9 weeks
Primary	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	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