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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)
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

Study 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.Check my eligibility
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.See study design
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.
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I am a suitable candidate for a vagus nerve stimulator implant.
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I am willing and able to follow all study rules and be available for its duration.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of Adverse Events [Device Safety]
Secondary outcome measures
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

Find a Location

Who is running the clinical trial?

University of Texas Southwestern Medical CenterOTHER
1,040 Previous Clinical Trials
1,048,092 Total Patients Enrolled
Defense Advanced Research Projects AgencyFED
18 Previous Clinical Trials
78,914 Total Patients Enrolled
Baylor Research InstituteLead Sponsor
198 Previous Clinical Trials
202,743 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

Frequently Asked Questions

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

Does this study permit octogenarians to participate?

"As per the stipulations of this clinical trial, participants must not exceed 64 years in age and should have surpassed 18."

Answered by AI

Does this research offer enrollment opportunities for participants?

"As indicated by clinicaltrials.gov, this research project is still enrolling participants. It was initially listed on December 16th 2020 and its details were last modified on May 25th 2021."

Answered by AI

Who is the ideal demographic for this research investigation?

"This clinical experiment is searching for 10 participants who have the corresponding ailment and are aged between 18 to 64."

Answered by AI

What is the current enrollment cap for this clinical trial?

"Correct. According to clinicaltrials.gov, the medical trial which first opened its doors on December 16th 2020 is currently accepting candidates. There are 10 places available at one location for this study."

Answered by AI

Who else is applying?

What state do they live in?
Texas
What site did they apply to?
Baylor University Medical Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
1
2
3+

What questions have other patients asked about this trial?

How long is the total study. And what is the compensation for it?
PatientReceived no prior treatments

Why did patients apply to this trial?

I've tried pills meditation I don't think it's working. I've tried multiple medications and counseling without any positive results. I think this trial would be a benefit to help me with my ptsd.
PatientReceived 1 prior treatment
I have tried several things with my psychologist and nothing has worked. A friend has been helped my VNS treatments and I would like to see if this will help me as well.
PatientReceived no prior treatments
I have been diagnosed with PTSD and tried several prescribed medications over the years. I now take 3 medications but still have problems. Three weeks ago I experienced my first anxiety attack and was rushed to an ER. The attack was terrifying to me and the two people with me. I desperately need help.
PatientReceived 1 prior treatment
Recent research and studies
~2 spots leftby Mar 2025