Phase
Condition
Post-traumatic Stress Disorders
Anxiety Disorders
Panic Disorders
Treatment
Senseye DT
CAPS-5-R
Clinical Study ID
Ages > 18 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Willing and able to read, understand, and sign the IRB-approved Informed ConsentForm.
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 ofadverse events (AEs), mental health treatment history, current and past psychiatricmedication, 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 aniPhone 11 or newer.
Exclusion
Exclusion Criteria:
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 moreschizophrenia-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, orother neurological conditions).
Current diagnosis of dementia, delirium, amnestic disorders, autism, hydrocephalus,posterior cortical atrophy, aphasia, multiple sclerosis, or stroke-related cognitivedysfunction.
Current eye disorders which prevent the patient from using the Senseye DT (completelist in full protocol).
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.
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).
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.
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).
Traumatic Brain Injury (TBI) within the last 12 months.
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.
Pregnant or intending on becoming pregnant during the duration of the study asdetermined by self-report.
Currently incarcerated.
Participant requires a legal guardian to consent.
Study Design
Study Description
Connect with a study center
University of Colorado Anschutz Medical Campus
Aurora, Colorado 80045
United StatesSite Not Available
Velocity Clinical Research
Meridian, Idaho 83642
United StatesSite Not Available
Ralph H. Johnson VA Health Care System
Charleston, South Carolina 29401
United StatesSite Not Available
Future Search Trials
Dallas, Texas 75231
United StatesSite Not Available
DHR Health Institute for Research and Development
Edinburg, Texas 78539
United StatesSite Not Available

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