Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:11 PM
Ignite Modification Date:
2025-12-24 @ 4:11 PM
NCT ID:
NCT03702166
Eligibility Criteria:
Inclusion Criteria:
* Adult military Veterans (age 18-60) who deployed in support of combat operations post-9/11 seeking behavioral health treatment for PTSD and/or tinnitus
* Diagnosis of PTSD determined by the Clinician-Administered PTSD Scale - Interview - Version 5 (CAPS-5)
* Ability to speak and read English
* Meets criteria for tinnitus and considers their tinnitus bothersome, as defined by a score on the Tinnitus Functional Index of 32 or greater
Exclusion Criteria:
* Currently receiving evidence based treatment for PTSD
* Current suicidal ideation severe enough to warrant immediate attention (as determined by the Depressive Symptoms Index- Suicidality Subscale and corroborated by a clinical risk assessment by a credentialed provider
* Psychiatric hospitalization in the last 12 months
* Current and severe alcohol use warranting immediate intervention based on clinical judgment
* Current manic episode or psychotic symptoms requiring immediate stabilization or hospitalization (as determined by the manic and psychosis modules of the MINI)
* Evidence of a moderate or severe traumatic brain injury (as determined by the inability to comprehend the baseline screening questionnaires)
* Neurobiological disorders
* Meniere's disease, temporomandibular joint disorders
* History of seizures
* History of penetrating head trauma or neurosurgery
* Metal objects implanted in the head, ferrous metal filings in the eye
* Inflammation of the brain
* Cardiac pacemaker
* Implanted medical pump or cardiac lines
* Heart disease
* Currently taking certain types of medication for depression or seizures (tricyclic antidepressants or neuroleptics which lower seizure threshold)
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT03702166
Study Brief:
Protocol Section:
NCT03702166