taVNS to Reduce PTSD Symptoms in WTC Responders

Completed · Not applicable · Has a placebo group

Conditions studied: Stress Disorders, Post-Traumatic

In brief

This study seeks to conduct a randomized, double-blind pilot study, to determine whether the Transcutaneous Auricular Vagus Nerve Stimulation and study procedure are feasible and acceptable for use with World Trade Center responders with Post Traumatic Stress Disorder.

Key facts

Study ID

NCT05212714

Run by

Northwell Health

People needed

30

Starts

2022-03-31

Expected to finish

2024-02-15

Last updated by the study team

2024-04-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 annual monitoring visit between 2018-2020
• having a score of 33 or greater on the PCL-594 delivered during the initial phone screen to determine current symptomatology
• meeting diagnostic indication of PTSD using a Clinician-Administered PTSD Scale (CAPS), which is a clinical interview assessment.95

You may not qualify if…

• 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, or current suicidal or homicidal intent/plan, as per the standard MINI neuropsychological assessment.96
• active disease involving the auricle or ear canal (e.g., otitis media, tinnitus, infection, perforated tympanic membrane, vestibular and/or balance, excessive cerumen production, 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 of the 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 the participant 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 severe congestive heart failure (New York Heart Association class III or IV); Recent (within past 6 months) cerebrovascular accident, myocardial infarction, coronary stenting; Uncontrolled hypertension as defined by a confirmed systolic blood pressure > 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 of the cervix) within the 5 years prior to study entry.
• history of concurrent illness that requires hospitalization within 30 days prior to study entry
• have hypertension/hypotension uncontrolled by medication
• participation in another investigational trial during the 30 days prior to study entry or during this project

Where it is running

• Feinstein Institutes for Medical Research — Manhasset, New York, United States

Full record on ClinicalTrials.gov

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