Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) to Reduce Post Traumatic Stress Disorder (PTSD) Symptoms in World Trade Center (WTC) Responders
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Stress Disorders, Post-Traumatic
- Sponsor
- Northwell Health
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Feasibility of Utilizing taVNS with WTCHP Responders as Measured By Rates of Recruitment
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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.
Investigators
Rebecca Schwartz
Associate Professor and Chief, Social Behavioral Sciences
Northwell Health
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.
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Feasibility of Utilizing taVNS with WTCHP Responders as Measured By Rates of Recruitment
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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 Outcomes
- Acceptability of taVNS by WTCHP Responders As Assessed by Percentage Missing Data(8 week follow-up)
- Acceptability of taVNS by WTCHP Responders As Assessed by Score of taVNS Satisfaction and Usefulness Questionnaire(8 week follow-up)
- Acceptability of taVNS by WTCHP Responders As Assessed by Time to Completion of Questionnaires and Biological Data(8 week follow-up)
- Acceptability of taVNS by WTCHP Responders As Assessed by Rate of Refusal(8 week follow-up)