Feasibility and ML Training Investigation of the Senseye DT for Diagnosis of Adults with PTSD

Last updated: December 6, 2024
Sponsor: Senseye, Inc.
Overall Status: Completed

Phase

N/A

Condition

Post-traumatic Stress Disorders

Anxiety Disorders

Panic Disorders

Treatment

Senseye DT

CAPS-5-R

Clinical Study ID

NCT05717439
CSP-PT-0003
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

The aim of this study is to obtain data on the feasibility of the Senseye Diagnostic Tool (DT) to assess the presence and severity of post-traumatic stress disorder (PTSD) symptoms. The study will also collect data on Generalized Anxiety Disorder (GAD) and Major Depressive Disorder (MDD) to aid in assessing the presence and severity of these disorders both for the purpose of discerning them from PTSD and determining the feasibility of diagnosing them independently.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Willing and able to read, understand, and sign the IRB-approved Informed ConsentForm.

  2. Age 18+.

  3. Study groups: Diagnosed with PTSD, GAD, and/or MDD.

  4. Control groups: Not diagnosed with PTSD, GAD, or MDD.

  5. Deemed likely to comply with the study protocol, including willing communication ofadverse events (AEs), mental health treatment history, current and past psychiatricmedication, and ability to attend all study follow-up visits.

  6. Medically stable as determined by the clinician or investigator.

  7. Virtual sites: Subject has access to a stable internet and WIFI connection and aniPhone 11 or newer.

Exclusion

Exclusion Criteria:

  1. Psychotic or self-injurious behavior.

  2. Current diagnosis of epilepsy and/or other current seizure disorders.

  3. A history of or positive at screening for bipolar I or II, mania, or one or moreschizophrenia-spectrum or other psychotic disorders, including schizophrenia,schizoaffective disorder, delusional disorder, and psychosis.

  4. Compromised facial neuro-ophthalmic integrity (e.g., due to stroke, MS, ALS, orother neurological conditions).

  5. Current diagnosis of dementia, delirium, amnestic disorders, autism, hydrocephalus,posterior cortical atrophy, aphasia, multiple sclerosis, or stroke-related cognitivedysfunction.

  6. Current eye disorders which prevent the patient from using the Senseye DT (completelist in full protocol).

  7. Active suicidal and/or homicidal intent which may put the participant and/or othersat risk per the investigator's clinical judgement, or has suicidal ideation withintent to act within 6 months prior to the start of the screening phase asdetermined by a C-SSRS score > 3, or history of suicidal behavior within the pastyear prior to the start of the screening phase.

  8. Current reported usage (within 2 weeks of Initial Study Visit and/or planned ongoingusage during the study) of psychotropic and/or non-psychotropic drugs/medicationwhich may affect use of the Senseye DT (complete list in full protocol).

  9. Current reported usage (within 2 weeks of Initial Study Visit and/or planned ongoingusage during the study) of vagal nerve stimulation, deep brain stimulation,transcranial magnetic stimulation, or electroconvulsive therapy.

  10. Any condition which precludes the ability for subjects to safely and accuratelycomplete clinical assessments, questionnaires, or to follow instructions necessaryto administer the Senseye DT (e.g., significant developmental disabilities, languagedisorders, cognitive deficiencies, or other neurodevelopmental disorders).

  11. Traumatic Brain Injury (TBI) within the last 12 months.

  12. Lifetime history of any of the following: surgical procedures involving the brain ormeninges, encephalitis, meningitis, degenerative central nervous system (CNS)disorder (e.g., Alzheimer's Disease, Parkinson's Disease), epilepsy, mentalretardation, or any other disease/procedure/accident/intervention that, according tothe clinician, is deemed associated with significant injury to, or malfunction of,the CNS.

  13. Pregnant or intending on becoming pregnant during the duration of the study asdetermined by self-report.

  14. Currently incarcerated.

  15. Participant requires a legal guardian to consent.

Study Design

Total Participants: 338
Treatment Group(s): 2
Primary Treatment: Senseye DT
Phase:
Study Start date:
March 01, 2023
Estimated Completion Date:
July 25, 2024

Study Description

This clinical study will be conducted to inform and train the Senseye DT's machine learning algorithm, to be evaluated in a future study for effectiveness in identifying people with PTSD compared to the Clinician-Administered PTSD Scale for DSM-5, revised version (CAPS-5-R) assessment. The Senseye DT is designed to utilize video data captured from a subject's eyes while they are presented various visual stimuli to extract ocular metrics (i.e., pupil size, gaze pattern, etc.) and heart rate data and use this information to detect the presence and severity of PTSD. Due to the overlapping symptomatology between PTSD, GAD, and MDD and common elements of ANS abnormalities (e.g., hyperarousal in both PTSD and GAD), it is necessary for the Senseye DT's specificity to discern between PTSD, GAD and MDD. This study is therefore designed to fully assess the presence and severity of each of these disorders in subjects to ensure device specificity as well as to test the feasibility to diagnose and rate severity of these conditions.

The study will be divided into two concurrent phases:

Phase I will focus on assessing the presence of PTSD via Screening through Baseline Study Visits. The objective of this phase is to obtain an accurate baseline diagnosis and severity rating for PTSD using Standard of Care methods and to use the Senseye DT to obtain data necessary for the device to be trained to produce a PTSD diagnosis. Baseline diagnosis and severity of GAD and MDD will also be determined.

Phase II will focus on assessing the severity of PTSD symptoms over time, with the objective to collect data necessary to train the Senseye DT machine learning algorithm to accurately determine a subject's PTSD severity rating correlated to the CAPS-5-R. Phase II consists of follow-up time points of 4 weeks, 8 weeks, and 12 weeks, and assesses changes in PTSD since the baseline severity determined in Phase I. Changes in GAD and MDD from baseline will also be assessed.

Connect with a study center

  • University of Colorado Anschutz Medical Campus

    Aurora, Colorado 80045
    United States

    Site Not Available

  • Velocity Clinical Research

    Meridian, Idaho 83642
    United States

    Site Not Available

  • Ralph H. Johnson VA Health Care System

    Charleston, South Carolina 29401
    United States

    Site Not Available

  • Future Search Trials

    Dallas, Texas 75231
    United States

    Site Not Available

  • DHR Health Institute for Research and Development

    Edinburg, Texas 78539
    United States

    Site Not Available

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