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Vagus Nerve Stimulation

Vagus Nerve Stimulation for Post-Traumatic Stress Disorder

N/A

Waitlist Available

Led By Michael Kilgard, PhD

Research Sponsored by Baylor Research Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Adult, aged 18-64

Patients diagnosed with chronic PTSD for at least 3 months based on the DSM-5 criteria (PSSI-5 score of 9-45)

Must not have

Significant comorbidities or conditions associated with high risk for surgical or anesthetic survival (e.g. renal failure, unstable cardiac disease, poorly controlled diabetes, immunosuppression, etc.)

Non-English speaking

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from week 1 through study follow-up, approximately two years from the date of implant

Awards & highlights

Summary

This trial is testing a new device to help people with PTSD by stimulating the vagus nerve. The device is paired with exposure therapy, which is a type of therapy that helps people with PTSD by having them face their fears. The trial will assess the safety of the device and the therapy, and will also help researchers understand if the device and therapy are effective.

Who is the study for?

Adults aged 18-64 with chronic PTSD for at least 3 months, who can give informed consent and follow study procedures. They must have normal vocal cord movement, use contraception if of reproductive potential, and be suitable for VNS implantation. Excluded are those on interfering therapies, pregnant or lactating women, individuals with significant health risks or conditions affecting the study's integrity, non-English speakers, prior vagus nerve injury cases, very severe PTSD sufferers (PSSI-5 score >45), and those with certain psychological conditions.

What is being tested?

The trial is testing a new device that delivers targeted plasticity therapy (TPT) via vagus nerve stimulation paired with prolonged exposure therapy to reduce PTSD symptoms. It aims to assess safety and provide an initial estimate of efficacy in preparation for a larger trial.

What are the potential side effects?

While not explicitly listed here, side effects may include discomfort from the device itself or surgical complications related to its implantation. Stimulation might cause voice changes due to its proximity to the vocal cords.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 64 years old.

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I have been diagnosed with chronic PTSD for over 3 months.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have major health issues like kidney failure or uncontrolled diabetes.

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I do not speak English.

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My symptoms are very severe, with a PSSI-5 score of 46 or more.

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I have health issues that make surgery risky for me.

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I don't have severe circulation issues that could affect a device being implanted.

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I have significant brain injuries.

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I have had or am currently undergoing vagus nerve stimulation treatment.

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I currently have active cancer.

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I am not on any treatments that would affect VNS therapy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from week 1 through study follow-up, approximately two years from the date of implant

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from week 1 through study follow-up, approximately two years from the date of implant

This trial's timeline: 3 weeks for screening, Varies for treatment, and from week 1 through study follow-up, approximately two years from the date of implant for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of Adverse Events [Device Safety]

Secondary study objectives

Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)

Generalized Anxiety Disorder 7-item Scale (GAD-7)

PTSD Checklist for DSM-5 (PCL-5)

+2 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Vagus Nerve Stimulation + Prolonged Exposure TherapyExperimental Treatment1 Intervention

Study treatment is vagus nerve stimulation (VNS) delivered during Prolonged Exposure Therapy.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Paired Vagus Nerve Stimulation

2017

N/A

~110

0 / 11Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Texas Southwestern Medical CenterOTHER

1,072 Previous Clinical Trials

1,056,253 Total Patients Enrolled

Defense Advanced Research Projects AgencyFED

18 Previous Clinical Trials

78,914 Total Patients Enrolled

Baylor Research InstituteLead Sponsor

205 Previous Clinical Trials

203,406 Total Patients Enrolled

Media Library

Paired Vagus Nerve Stimulation (Vagus Nerve Stimulation) Clinical Trial Eligibility Overview. Trial Name: NCT04064762 — N/A

Post-Traumatic Stress Disorder Research Study Groups: Vagus Nerve Stimulation + Prolonged Exposure Therapy

Post-Traumatic Stress Disorder Clinical Trial 2023: Paired Vagus Nerve Stimulation Highlights & Side Effects. Trial Name: NCT04064762 — N/A

Paired Vagus Nerve Stimulation (Vagus Nerve Stimulation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04064762 — N/A

Post-Traumatic Stress Disorder Patient Testimony for trial: Trial Name: NCT04064762 — N/A

~2 spots leftby Sep 2025

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