taVNS to Reduce PTSD Symptoms in WTC Responders

Inclusion Criteria:

• being a Queens WTCHP responder who agreed to be contacted to participate in research
• having PTSD as per DSM criteria indicated by the GRDC
• having elevated PTSD symptoms, indicated by a PCL-S93 score > 44 during an annualmonitoring visit between 2018-2020
• having a score of 33 or greater on the PCL-594 delivered during the initial phonescreen to determine current symptomatology
• meeting diagnostic indication of PTSD using a Clinician-Administered PTSD Scale (CAPS), which is a clinical interview assessment.95

Exclusion criteria:

• being physically/mentally unable to consent and participate
• inability to speak, read, or write in English,
• exhibiting any current psychotic or manic symptoms, active substance dependence, orcurrent suicidal or homicidal intent/plan, as per the standard MINI neuropsychologicalassessment.96
• active disease involving the auricle or ear canal (e.g., otitis media, tinnitus,infection, perforated tympanic membrane, vestibular and/or balance, excessive cerumenproduction, skin irritation), unwilling to remove a piercing (e.g., daith or tragus),or use a device (e.g., hearing aid, cochlear implant) that would preclude daily use ofthe earpiece.
• history of unilateral or bilateral vagotomy.
• Current pregnancy (self-report)
• previously implanted electrically active medical devices (e.g., cardiac pacemakers,automatic implantable cardioverter-defibrillators, VNS).
• other major conditions, that in the judgment of the investigators/WTCHP medical staff,would make the participant unsuitable for inclusion or would interfere with theparticipant participating in or completing the study. these include:
• current treatment with psychotropic medication, including tricyclics,antipsychotics, mood stabilizers, bupropion, barbiturates, stimulants,antiepileptics, opioid medications.
• current diagnosis or history of any clinically significant cardiac,endocrinologic, pulmonary, neurologic, psychiatric, hepatic, renal, hematologic,neurologic, gastrointestinal, or immunologic.
• history of any of the following cardiovascular conditions: Moderate to severecongestive heart failure (New York Heart Association class III or IV); Recent (within past 6 months) cerebrovascular accident, myocardial infarction, coronarystenting; Uncontrolled hypertension as defined by a confirmed systolic bloodpressure > 160 mmHg or diastolic blood pressure > 100 mmHg.
• history of or active seizure disorder.
• history of recurrent vasovagal syncope episodes.
• diagnosis of cancer (other than non-invasive skin cancer or carcinoma in-situ ofthe cervix) within the 5 years prior to study entry.
• history of concurrent illness that requires hospitalization within 30 days priorto study entry
• have hypertension/hypotension uncontrolled by medication
• participation in another investigational trial during the 30 days prior to studyentry or during this project