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Stress Disorders, Post-TraumatictaVNSNCT05212714

taVNS to Reduce PTSD Symptoms in WTC Responders

A study testing taVNS in people with Stress Disorders, Post-Traumatic, run by Northwell Health at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Stress Disorders, Post-Traumatic
What is being tested?
taVNS
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
30 participants
Where
1 siteUnited States
Study dates
31 Mar 2022to 15 Feb 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)
Show all 17Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Feinstein Institutes for Medical Research

    Manhasset, New York, 11030

Other trials in United States

About this study

Official title: Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) to Reduce Post Traumatic Stress Disorder (PTSD) Symptoms in World Trade Center (WTC) Responders

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.

Read the 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.

Being tested
taVNS
Keywords
feasibility and acceptability, WTC responders, taVNS
Medical subject headings
Stress Disorders, Post-Traumatic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • taVNSDevice

    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.

Study groups in NCT05212714
Study groupRoleWhat they receive
taVNS TreatmentExperimentaln = 20
Receives: Device: taVNS
Sham ComparatorSham comparatorn = 10
Receives: Device: taVNS

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 8 week follow-up

  2. 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.

    Measured: 8 week follow-up

  3. 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.

    Measured: 8 week follow-up

  4. 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.

    Measured: 8 week follow-up

  5. 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.

    Measured: 8 week follow-up

Secondary outcomes (4)

  1. Acceptability of taVNS by WTCHP Responders As Assessed by Time to Completion of Questionnaires and Biological Data

    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.

    Measured: 8 week follow-up

  2. Acceptability of taVNS by WTCHP Responders As Assessed by Percentage Missing Data

    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.

    Measured: 8 week follow-up

  3. Acceptability of taVNS by WTCHP Responders As Assessed by Rate of Refusal

    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.

    Measured: 8 week follow-up

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

    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.

    Measured: 8 week follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jan 2022
  2. Study start31 Mar 2022
  3. Primary completion15 Feb 2024
  4. Study completion15 Feb 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
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.
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05212714
Sponsor's protocol ID
21-0640
Other IDs
U01OH012050
Acronym
taVNS
Status last verified
Apr 2024
First submitted
9 Sep 2021
Last updated
3 Apr 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes

Publications

  • Debnath S, Cook HM, Shaam P, Ryniker L, Fylaktou F, Lieberman L, McCann Pineo M, Deligiannidis KM, Zanos TP, Schwartz RM. Effects of Transcutaneous Auricular Vagus Nerve Stimulation on Posttraumatic Stress Disorder Symptoms in World Trade Center Responders: A Feasibility and Acceptability Study. Int J Environ Res Public Health. 2026 Mar 21;23(3):401. doi: 10.3390/ijerph23030401.

    PubMed 41899778

Questions about this trial

What is this clinical trial studying?

A study testing taVNS in people with Stress Disorders, Post-Traumatic, run by Northwell Health at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility of Utilizing taVNS with WTCHP Responders as Measured By Rates of Recruitment (time frame: 8 week follow-up). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05212714, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2024.

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