Feasibility and ML Training Investigation of the Senseye DT for Diagnosis of Adults with PTSD
NCT ID: NCT05717439
Last Updated: 2024-12-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
338 participants
OBSERVATIONAL
2023-03-01
2024-07-25
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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PTSD positive
Subjects meet criteria for PTSD, with or without comorbid Generalized Anxiety Disorder or Major Depressive Disorder
CAPS-5-R
A semi-structured clinical interview to assess core PTSD symptoms for diagnosis and severity rating.
Senseye DT
Using a machine learning algorithm, Senseye DT will record a series of visual tasks, pupil light reflex, vascular function and heart rate measurement throughout.
Primary GAD
Subjects DO NOT meet criteria for PTSD, but meet criteria for Generalized Anxiety Disorder
CAPS-5-R
A semi-structured clinical interview to assess core PTSD symptoms for diagnosis and severity rating.
Senseye DT
Using a machine learning algorithm, Senseye DT will record a series of visual tasks, pupil light reflex, vascular function and heart rate measurement throughout.
Primary MDD
Subjects DO NOT meet criteria for PTSD, but meet criteria for Major Depressive Disorder
CAPS-5-R
A semi-structured clinical interview to assess core PTSD symptoms for diagnosis and severity rating.
Senseye DT
Using a machine learning algorithm, Senseye DT will record a series of visual tasks, pupil light reflex, vascular function and heart rate measurement throughout.
Comorbid GAD/MDD
Subjects DO NOT meet criteria for PTSD, but meet criteria for Generalized Anxiety Disorder and Major Depressive Disorder
CAPS-5-R
A semi-structured clinical interview to assess core PTSD symptoms for diagnosis and severity rating.
Senseye DT
Using a machine learning algorithm, Senseye DT will record a series of visual tasks, pupil light reflex, vascular function and heart rate measurement throughout.
Trauma-positive, PTSD/GAD/MDD-negative
Subjects have trauma exposure meeting DSM-5-TR Criterion A, but DO NOT meet criteria for PTSD, GAD, or MDD
CAPS-5-R
A semi-structured clinical interview to assess core PTSD symptoms for diagnosis and severity rating.
Senseye DT
Using a machine learning algorithm, Senseye DT will record a series of visual tasks, pupil light reflex, vascular function and heart rate measurement throughout.
Trauma-negative
Subjects DO NOT have trauma exposure meeting DSM-5-TR Criterion A and DO NOT meet criteria for PTSD, GAD, or MDD
Senseye DT
Using a machine learning algorithm, Senseye DT will record a series of visual tasks, pupil light reflex, vascular function and heart rate measurement throughout.
Interventions
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CAPS-5-R
A semi-structured clinical interview to assess core PTSD symptoms for diagnosis and severity rating.
Senseye DT
Using a machine learning algorithm, Senseye DT will record a series of visual tasks, pupil light reflex, vascular function and heart rate measurement throughout.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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 of adverse events (AEs), mental health treatment history, current and past psychiatric medication, 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 an iPhone 11 or newer.
Exclusion Criteria
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 more schizophrenia-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, or other neurological conditions).
5. Current diagnosis of dementia, delirium, amnestic disorders, autism, hydrocephalus, posterior cortical atrophy, aphasia, multiple sclerosis, or stroke-related cognitive dysfunction.
6. Current eye disorders which prevent the patient from using the Senseye DT (complete list in full protocol).
7. Active suicidal and/or homicidal intent which may put the participant and/or others at risk per the investigator's clinical judgement, or has suicidal ideation with intent to act within 6 months prior to the start of the screening phase as determined by a C-SSRS score \> 3, or history of suicidal behavior within the past year prior to the start of the screening phase.
8. Current reported usage (within 2 weeks of Initial Study Visit and/or planned ongoing usage during the study) of psychotropic and/or non-psychotropic drugs/medication which 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 ongoing usage 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 accurately complete clinical assessments, questionnaires, or to follow instructions necessary to administer the Senseye DT (e.g., significant developmental disabilities, language disorders, 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 or meninges, encephalitis, meningitis, degenerative central nervous system (CNS) disorder (e.g., Alzheimer's Disease, Parkinson's Disease), epilepsy, mental retardation, or any other disease/procedure/accident/intervention that, according to the 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 as determined by self-report.
14. Currently incarcerated.
15. Participant requires a legal guardian to consent.
18 Years
ALL
Yes
Sponsors
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Senseye, Inc.
INDUSTRY
Responsible Party
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Locations
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University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States
Velocity Clinical Research
Meridian, Idaho, United States
Ralph H. Johnson VA Health Care System
Charleston, South Carolina, United States
Future Search Trials
Dallas, Texas, United States
DHR Health Institute for Research and Development
Edinburg, Texas, United States
Countries
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Other Identifiers
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CSP-PT-0003
Identifier Type: -
Identifier Source: org_study_id