Senseye's OBCI Diagnostic Tool for PTSD

Senseye

Status: Terminated

Conditions: PTSD

Treatments: Diagnostic Test: Senseye OBCI; Diagnostic Test: CAPS-5 Assessment

Study type: Observational

Funder types: Industry

Identifiers

NCT05372523

SEN-01-2022

Details and patient eligibility

About

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.

Full 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.

Enrollment: 61 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

61 participants in 3 patient groups

Trauma+ & PTSD

Description:

Patients diagnosed with significant trauma exposure and PTSD

Treatment:

Diagnostic Test: Senseye OBCI

Diagnostic Test: CAPS-5 Assessment

Trauma+ & No PTSD

Description:

Patients diagnosed with significant trauma exposure but no PTSD

Treatment:

Diagnostic Test: Senseye OBCI

Diagnostic Test: CAPS-5 Assessment

No trauma or PTSD

Description:

Healthy adults without known major psychiatric disorders

Treatment:

Diagnostic Test: Senseye OBCI

Diagnostic Test: CAPS-5 Assessment