taVNS to Reduce PTSD Symptoms in WTC Responders

NCT05212714 | Completed DMC FDA Device

• 2 other identifiers: 21-0640U01OH012050
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Stress Disorders, Post-Traumatic

Keywords

feasibility and acceptability; WTC responders; taVNS

Outcome Measures

Primary Outcomes (5)

• Feasibility of Utilizing taVNS with WTCHP Responders as Measured By Rates of Recruitment

  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.

  8 week follow-up

• Feasibility of Utilizing taVNS with WTCHP Responders as Measured By Intervention Adherence

  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.

  8 week follow-up

• Feasibility of Utilizing taVNS with WTCHP Responders as Measured By Retention Rates

  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.

  8 week follow-up

• Feasibility of Utilizing taVNS with WTCHP Responders as Measured By Duration

  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.

  8 week follow-up

• Feasibility of Utilizing taVNS with WTCHP Responders as Measured By Completion Rates

  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.

  8 week follow-up

Secondary Outcomes (4)

• 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 Percentage Missing Data

  8 week follow-up

• Acceptability of taVNS by WTCHP Responders As Assessed by Rate of Refusal

  8 week follow-up

• Acceptability of taVNS by WTCHP Responders As Assessed by Score of taVNS Satisfaction and Usefulness Questionnaire

  8 week follow-up

Other Outcomes (11)

• Mental Health Measures

  Baseline and 8 week follow-up

• PTSD

  Baseline and 8 week follow-up

• Biologic Potential Endpoints - Heart Rate

  Baseline and 8 week follow-up

Study Arms (2)

taVNS Treatment

EXPERIMENTAL

n = 20

Device: taVNS

Sham Comparator

SHAM COMPARATOR

n = 10

Device: taVNS

Interventions

taVNS DEVICE

The non-invasive transcutaneous auricular vagus nerve stimulation (taVNS) device that will be used in this study is a wearable TENS unit called the Vorso STIM100 System. The Vorso system consists of a wearable, external stimulator, a neural interface ear piece, and an arm band designed to be safe for human contact. The external stimulator generates electrical pulses that are transcutaneously delivered to the auricular branch of the vagus nerve through the ear canal. The ear piece contains 4 electrodes that carry current from the external stimulator to the auricular branch of vagus nerve. The external stimulator connects to a flexible arm band that attaches to the upper arm for ease of use during each stimulation session. The type of stimulation (including shape, frequency, pulse width, amplitude, total charge, and energy delivered) is comparable to the levels applied by commercially available TENS stimulators. The sham control group will not receive any stimulation.

Sham Comparator; taVNS Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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).
• 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

Sponsors & Collaborators

• Northwell Health: lead

Study Sites (1)

Feinstein Institutes for Medical Research

Manhasset, New York, 11030, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Rebecca Schwartz, PhD

  Northwell Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor and Chief, Social Behavioral Sciences

Model Details: 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.

Study Record Dates

• First Submitted: September 9, 2021
• First Posted: January 28, 2022
• Study Start: March 31, 2022
• Primary Completion: February 15, 2024
• Study Completion: February 15, 2024
• Last Updated: April 3, 2024

Record last verified: 2024-04

Locations

US (1)