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Device

Non-Invasive Vagus Nerve Stimulation for Post-Traumatic Stress Disorder (taVNS Trial)

N/A
Waitlist Available
Led By Rebecca Schwartz, PhD
Research Sponsored by Northwell Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Meeting diagnostic indication of PTSD using a Clinician-Administered PTSD Scale (CAPS), which is a clinical interview assessment.
Having PTSD as per DSM criteria indicated by the GRDC
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 week follow-up
Awards & highlights

taVNS Trial Summary

This trial will study whether a non-invasive vagus nerve stimulator can help people with PTSD from the World Trade Center respond better to treatment.

Who is the study for?
This trial is for Queens WTCHP responders with PTSD, scoring above certain thresholds on PTSD assessments. Participants must have a diagnosis of PTSD and elevated symptoms from recent visits. Exclusions include current severe mental health issues, inability to consent, non-English speakers, pregnancy, electronic medical implants, certain medications or cardiovascular conditions.Check my eligibility
What is being tested?
The study tests Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) feasibility and acceptability in treating PTSD in World Trade Center responders. It's a randomized pilot study where participants won't know if they're getting the real treatment or a placebo.See study design
What are the potential side effects?
While not explicitly listed here, taVNS can potentially cause side effects like headache, dizziness, skin irritation at the stimulation site or ear discomfort due to its action on the vagus nerve.

taVNS Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been diagnosed with PTSD by a professional using the CAPS assessment.
Select...
I have been diagnosed with PTSD according to the DSM.

taVNS Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 week follow-up
This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 week follow-up for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Feasibility of Utilizing taVNS with WTCHP Responders as Measured By Completion Rates
Feasibility of Utilizing taVNS with WTCHP Responders as Measured By Duration
Feasibility of Utilizing taVNS with WTCHP Responders as Measured By Intervention Adherence
+2 more
Secondary outcome measures
Acceptability of taVNS by WTCHP Responders As Assessed by Percentage Missing Data
Acceptability of taVNS by WTCHP Responders As Assessed by Rate of Refusal
Acceptability of taVNS by WTCHP Responders As Assessed by Score of taVNS Satisfaction and Usefulness Questionnaire
+1 more
Other outcome measures
Biologic Potential Endpoints - Blood Pressure
Electroencephalography
Electromyography
+8 more

taVNS Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: taVNS TreatmentExperimental Treatment1 Intervention
n = 20
Group II: Sham ComparatorPlacebo Group1 Intervention
n = 10
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
taVNS
2011
Completed Phase 4
~220

Find a Location

Who is running the clinical trial?

Northwell HealthLead Sponsor
458 Previous Clinical Trials
470,903 Total Patients Enrolled
Rebecca Schwartz, PhDPrincipal InvestigatorNorthwell Health

Media Library

taVNS (Device) Clinical Trial Eligibility Overview. Trial Name: NCT05212714 — N/A
Post-Traumatic Stress Disorder Research Study Groups: taVNS Treatment, Sham Comparator
Post-Traumatic Stress Disorder Clinical Trial 2023: taVNS Highlights & Side Effects. Trial Name: NCT05212714 — N/A
taVNS (Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05212714 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what capacity has this experiment been populated?

"Affirmative. Information on clinicaltrials.gov indicates that this research project is in the process of recruiting participants and was initially posted on March 31st 2022, with a subsequent update made April 1st 2022. 30 individuals are required to be recruited from one centre for participation."

Answered by AI

What outcomes does this medical trial hope to accomplish?

"This experiment, to be assessed over an 8 week period, seeks to explore the practicality of utilising taVNS with WTCHP Responders as measured by recruitment rates. Further metrics include acceptability (refusal rate, time-to-completion and percentage missing data) between taVNS and sham groups which will be described using frequency/percentage or mean values along with corresponding 95% confidence intervals for precision."

Answered by AI

Are there any enrollment slots currently available for this research endeavor?

"Affirmative. According to the clinicaltrials.gov records, this clinical trial is actively enrolling participants who meet their criteria. It was first announced on March 31st 2022 and last modified on April 1st 2022; 30 patients are needed at a single medical centre for its completion."

Answered by AI

Who else is applying?

What state do they live in?
New York
How old are they?
18 - 65
What site did they apply to?
Feinstein Institutes for Medical Research
What portion of applicants met pre-screening criteria?
Met criteria
~10 spots leftby Apr 2025