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

Completed

Conditions studied: PTSD, Generalized Anxiety Disorder, Major Depressive Disorder

In brief

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.

Key facts

Study ID

NCT05717439

Run by

Senseye, Inc.

People needed

338

Starts

2023-03-01

Expected to finish

2024-07-25

Last updated by the study team

2024-12-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Willing and able to read, understand, and sign the IRB-approved Informed Consent Form.
• Age 18+.
• Study groups: Diagnosed with PTSD, GAD, and/or MDD.
• Control groups: Not diagnosed with PTSD, GAD, or MDD.
• 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.
• Medically stable as determined by the clinician or investigator.
• Virtual sites: Subject has access to a stable internet and WIFI connection and an iPhone 11 or newer.

You may not qualify if…

• Psychotic or self-injurious behavior.
• Current diagnosis of epilepsy and/or other current seizure disorders.
• 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.
• Compromised facial neuro-ophthalmic integrity (e.g., due to stroke, MS, ALS, or other neurological conditions).
• Current diagnosis of dementia, delirium, amnestic disorders, autism, hydrocephalus, posterior cortical atrophy, aphasia, multiple sclerosis, or stroke-related cognitive dysfunction.
• Current eye disorders which prevent the patient from using the Senseye DT (complete list in full protocol).
• 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.
• 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).
• 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.
• 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).
• Traumatic Brain Injury (TBI) within the last 12 months.
• 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.
• Pregnant or intending on becoming pregnant during the duration of the study as determined by self-report.
• Currently incarcerated.
• Participant requires a legal guardian to consent.

Where it is running

• 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

Full record on ClinicalTrials.gov

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