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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
Having PTSD as per DSM criteria indicated by the GRDC
Be older than 18 years old
Must not have
Have hypertension/hypotension uncontrolled by medication
History of concurrent illness that requires hospitalization within 30 days prior to study entry
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 week follow-up
Awards & highlights

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with PTSD according to the DSM.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My blood pressure is not controlled by medication.
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I have not been hospitalized for another illness in the last 30 days.
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I have had surgery to cut the nerves to my stomach.
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I have a history of fainting spells due to sudden drops in heart rate and blood pressure.
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I have a history of seizures or currently experience them.
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I am able to understand and agree to participate in the study.
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I am currently taking medication for mental health issues.

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

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
~250

Find a Location

Who is running the clinical trial?

Northwell HealthLead Sponsor
461 Previous Clinical Trials
471,105 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
~9 spots leftby Jul 2025
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