Clinical trial NCT05212714: taVNS to Reduce PTSD Symptoms in WTC Responders
Official title: Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) to Reduce Post Traumatic Stress Disorder (PTSD) Symptoms in World Trade Center (WTC) Responders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress Disorders, Post-Traumatic
Keywords: feasibility and acceptability
WTC responders
taVNS
Lead sponsor: Northwell Health
Sponsor class: OTHER
First posted: 2022-01-28
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study seeks to conduct a randomized, double-blind placebo-controlled parallel-design pilot study, to determine whether the taVNS intervention and study methodology are feasible and acceptable for use with WTC responders with PTSD. It is important that the design is double-blind and placebo-controlled in order to have the most appropriate control and to limit bias on the part of the participant and investigators. In addition, as this is a feasibility study, it is important to replicate the methodology that will eventually be used with a larger trial in order to truly assess whether the intervention and methodology are acceptable, feasible and efficacious.
Primary purpose: OTHER

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 with World Trade Center responders with Post Traumatic Stress Disorder.

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 questionnaire. They will also be given a phone to interface with the device and record their usage and will use the device for one 15-minute session under the supervision of members of the research team and be monitored using a combination of non-invasive equipment, including an brain activity monitoring cap, blood pressure cuff (to monitor blood pressure), a respiratory belt (to monitor respirations) and an eye tracking device (to monitor eye movement). Researchers are using these tests to see if there are any inflammatory, neural, and cardiovascular changes that relate to the treatment. A research nurse will collect 12 mL of blood (roughly 2 tsp) before and after their session. Blood will be drawn to look at markers of inflammation before using the device, after using the device, and again at the 6-week follow-up visit. They will then be asked to complete a survey regarding the stimulation device on an iPad. After their initial visit, they will be instructed to use the device twice a day, every day at home, for 15 minutes over 8 weeks. After 8 weeks, they will be asked to come in for a final visit, where they will be asked to complete another 15-minute device session, blood draw and survey regarding their experiences.

Eligibility criteria: 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

Primary outcomes:
measure: Feasibility of Utilizing taVNS with WTCHP Responders as Measured By Rates of Recruitment
timeFrame: 8 week follow-up
measure: Feasibility of Utilizing taVNS with WTCHP Responders as Measured By Intervention Adherence
timeFrame: 8 week follow-up
measure: Feasibility of Utilizing taVNS with WTCHP Responders as Measured By Retention Rates
timeFrame: 8 week follow-up
measure: Feasibility of Utilizing taVNS with WTCHP Responders as Measured By Duration
timeFrame: 8 week follow-up
measure: Feasibility of Utilizing taVNS with WTCHP Responders as Measured By Completion Rates
timeFrame: 8 week follow-up
Secondary outcomes:
measure: Acceptability of taVNS by WTCHP Responders As Assessed by Time to Completion of Questionnaires and Biological Data
timeFrame: 8 week follow-up
measure: Acceptability of taVNS by WTCHP Responders As Assessed by Percentage Missing Data
timeFrame: 8 week follow-up
measure: Acceptability of taVNS by WTCHP Responders As Assessed by Rate of Refusal
timeFrame: 8 week follow-up
measure: Acceptability of taVNS by WTCHP Responders As Assessed by Score of taVNS Satisfaction and Usefulness Questionnaire
timeFrame: 8 week follow-up
Other outcomes:
measure: Mental Health Measures
timeFrame: Baseline and 8 week follow-up
measure: PTSD
timeFrame: Baseline and 8 week follow-up
measure: Biologic Potential Endpoints - Heart Rate
timeFrame: Baseline and 8 week follow-up
measure: Biologic Potential Endpoints - Galvanic Skin Response
timeFrame: Baseline and 8 week follow-up
measure: Biologic Potential Endpoints - Skin Temperature
timeFrame: Baseline and 8 week follow-up
measure: Biologic Potential Endpoints - Respiratory Rate
timeFrame: Baseline and 8 week follow-up
measure: Biologic Potential Endpoints - Blood Pressure
timeFrame: Baseline and 8 week follow-up
measure: Biologic Potential Endpoints - EMG
timeFrame: Baseline and 8 week follow-up
measure: Biologic Potential Endpoints - EEG
timeFrame: Baseline and 8 week follow-up
measure: Biologic Potential Endpoints - Pupil Dilation
timeFrame: Baseline and 8 week follow-up
measure: Markers of Inflammation - TNFα, (IL)-1β, IL-6, IL-10, IL-12, IL-17, CRP, cortisol, and alpha amylase
timeFrame: Baseline and 8 week follow-up
Locations:
city: Manhasset
country: United States
facility: Feinstein Institutes for Medical Research
state: New York
Study officials:
affiliation: Northwell Health
name: Rebecca Schwartz, PhD
role: PRINCIPAL_INVESTIGATOR
References: