taVNS to Reduce PTSD Symptoms in WTC Responders

Not Applicable

Completed

• Conditions: Stress Disorders, Post-Traumatic
• Interventions: Device: taVNS

• Registration Number: NCT05212714
• Lead Sponsor: Northwell Health

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.

Study Timeline

• Study First Submitted: 2021-09-09
• Study First Submitted QC: 2022-01-14
• Study First Posted: 2022-01-28
• Study Start: 2022-03-31
• Primary Completion: 2024-02-15
• Study Completion: 2024-02-15
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-02
• Last Update Posted: 2024-04-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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 Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham Comparator	taVNS	n = 10
taVNS Treatment	taVNS	n = 20

Primary Outcome Measures

Name	Time	Method
Feasibility of Utilizing taVNS with WTCHP Responders as Measured By Rates of Recruitment	8 week follow-up	Evaluated as: (1) rates of recruitment (per month); All measures will be described using frequency and percent or mean (SD) as appropriate, overall and by taVNS and sham group, with corresponding 95% confidence intervals to interpret the precision of the estimates. Median and interquartile range may also be used if discrete data are skewed.
Feasibility of Utilizing taVNS with WTCHP Responders as Measured By Intervention Adherence	8 week follow-up	Evaluated as: (2) adherence to the taVNS intervention; All measures will be described using frequency and percent or mean (SD) as appropriate, overall and by taVNS and sham group, with corresponding 95% confidence intervals to interpret the precision of the estimates. Median and interquartile range may also be used if discrete data are skewed.
Feasibility of Utilizing taVNS with WTCHP Responders as Measured By Duration	8 week follow-up	Evaluated as: (4) duration of study assessments; All measures will be described using frequency and percent or mean (SD) as appropriate, overall and by taVNS and sham group, with corresponding 95% confidence intervals to interpret the precision of the estimates. Median and interquartile range may also be used if discrete data are skewed.
Feasibility of Utilizing taVNS with WTCHP Responders as Measured By Retention Rates	8 week follow-up	Evaluated as: (3) 8-week retention; All measures will be described using frequency and percent or mean (SD) as appropriate, overall and by taVNS and sham group, with corresponding 95% confidence intervals to interpret the precision of the estimates. Median and interquartile range may also be used if discrete data are skewed.
Feasibility of Utilizing taVNS with WTCHP Responders as Measured By Completion Rates	8 week follow-up	Evaluated as: (5) completion rate of study assessments; All measures will be described using frequency and percent or mean (SD) as appropriate, overall and by taVNS and sham group, with corresponding 95% confidence intervals to interpret the precision of the estimates. Median and interquartile range may also be used if discrete data are skewed.

Secondary Outcome Measures

Name	Time	Method
Acceptability of taVNS by WTCHP Responders As Assessed by Percentage Missing Data	8 week follow-up	Assessing: (2) percentage of missing data from questionnaires; All measures will be described using frequency and percent or mean (SD) as appropriate, overall and by taVNS and sham group, with corresponding 95% confidence intervals to interpret the precision of the estimates. Median and interquartile range may also be used if discrete data are skewed.
Acceptability of taVNS by WTCHP Responders As Assessed by Score of taVNS Satisfaction and Usefulness Questionnaire	8 week follow-up	Assessing: (4) the score on the taVNS Satisfaction and Usefulness Questionnaire; All measures will be described using frequency and percent or mean (SD) as appropriate, overall and by taVNS and sham group, with corresponding 95% confidence intervals to interpret the precision of the estimates. Median and interquartile range may also be used if discrete data are skewed.
Acceptability of taVNS by WTCHP Responders As Assessed by Time to Completion of Questionnaires and Biological Data	8 week follow-up	Assessing: (1) the time to completion of questionnaires and biological data/blood draw; All measures will be described using frequency and percent or mean (SD) as appropriate, overall and by taVNS and sham group, with corresponding 95% confidence intervals to interpret the precision of the estimates. Median and interquartile range may also be used if discrete data are skewed.
Acceptability of taVNS by WTCHP Responders As Assessed by Rate of Refusal	8 week follow-up	Assessing: (3) the rate of refusal of biologic measurements and blood draw; All measures will be described using frequency and percent or mean (SD) as appropriate, overall and by taVNS and sham group, with corresponding 95% confidence intervals to interpret the precision of the estimates. Median and interquartile range may also be used if discrete data are skewed.

Trial Locations

Locations (1)

Feinstein Institutes for Medical Research; 🇺🇸 Manhasset, New York, United States