Clinical trial NCT05372523: Senseye's OBCI Diagnostic Tool for PTSD
Official title: Pilot Investigation of Senseye's Ocular Brain-Computer Interface (OBCI) for Diagnosis of Adult With Post-Traumatic Stress Disorder (PTSD)
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: PTSD
Lead sponsor: Senseye, Inc.
Sponsor class: INDUSTRY
First posted: 2022-05-12
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults presenting to the clinic with potential psychiatric disorder, to include PTSD

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Agreement between Senseye OBCI measures and gold-standard measures
timeFrame: 9 weeks
measure: Feasibility of the Senseye tool
timeFrame: 9 weeks
measure: Test-retest for repeatability of the Senseye tool
timeFrame: 1 week
Secondary outcomes:
measure: Prognostic value by comparing Senseye OBCI to core PTSD symptoms
timeFrame: 9 weeks
Other outcomes:
Locations:
city: Sylmar
country: United States
facility: Olive View - UCLA Medical Center
state: California
Study officials:
affiliation: Olive View - UCLA
name: Naser Ahmadi, MD
role: PRINCIPAL_INVESTIGATOR
References: