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Senseye's OBCI Diagnostic Tool for PTSD

Sponsor
Senseye, Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05372523
Collaborator
(none)
68
Enrollment
1
Location
6.5
Anticipated Duration (Months)
10.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Anticipated Enrollment :
68 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Pilot Investigation of Senseye's Ocular Brain-Computer Interface (OBCI) for Diagnosis of Adult With Post-Traumatic Stress Disorder (PTSD)
Actual Study Start Date :
Apr 25, 2022
Anticipated Primary Completion Date :
Aug 25, 2022
Anticipated Study Completion Date :
Nov 10, 2022

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. 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.

  2. Feasibility of the Senseye tool [9 weeks]

    Feasibility will be assessed by evaluating retention rate.

  3. 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

  1. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Olive View - UCLA Medical Center Sylmar California United States 91342

Sponsors and Collaborators

  • Senseye, Inc.

Investigators

  • Principal Investigator: Naser Ahmadi, MD, Olive View - UCLA

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Senseye, Inc.
ClinicalTrials.gov Identifier:
NCT05372523
Other Study ID Numbers:
  • SEN-01-2022
First Posted:
May 12, 2022
Last Update Posted:
May 12, 2022
Last Verified:
May 1, 2022
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

Study Results

No Results Posted as of May 12, 2022