Status:
COMPLETED
taVNS to Reduce PTSD Symptoms in WTC Responders
Lead Sponsor:
Northwell Health
Conditions:
Stress Disorders, Post-Traumatic
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 wi...
Detailed Description
Participants will be randomized to one of two groups; one that receives stimulation and one that does not. Once their device is ready (roughly 1 month), they will be asked to participate in a baseline...
Eligibility Criteria
Inclusion
- 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 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
- 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, 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
Exclusion
Key Trial Info
Start Date :
March 31 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 15 2024
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT05212714
Start Date
March 31 2022
End Date
February 15 2024
Last Update
April 3 2024
Active Locations (1)
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1
Feinstein Institutes for Medical Research
Manhasset, New York, United States, 11030