Your session is about to expire
← Back to Search
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
No Placebo-Only Group
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 belowSelect...
I am between 18 and 64 years old.
Select...
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:Select...
I do not have major health issues like kidney failure or uncontrolled diabetes.
Select...
I do not speak English.
Select...
My symptoms are very severe, with a PSSI-5 score of 46 or more.
Select...
I have health issues that make surgery risky for me.
Select...
I don't have severe circulation issues that could affect a device being implanted.
Select...
I have significant brain injuries.
Select...
I have had or am currently undergoing vagus nerve stimulation treatment.
Select...
I currently have active cancer.
Select...
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
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 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
1,089 Previous Clinical Trials
1,059,674 Total Patients Enrolled
Defense Advanced Research Projects AgencyFED
18 Previous Clinical Trials
78,914 Total Patients Enrolled
Baylor Research InstituteLead Sponsor
206 Previous Clinical Trials
203,416 Total Patients Enrolled
The University of Texas at DallasOTHER
67 Previous Clinical Trials
108,098 Total Patients Enrolled
Ann Marie Warren, PhDStudy DirectorBaylor Health Care System
2 Previous Clinical Trials
330 Total Patients Enrolled
Michael Kilgard, PhDPrincipal InvestigatorUniversity of Texas at Dallas
3 Previous Clinical Trials
70 Total Patients Enrolled
Robert Rennaker, PhDPrincipal InvestigatorUniversity of Texas at Dallas
3 Previous Clinical Trials
70 Total Patients Enrolled
Seth Hays, PhDStudy DirectorUniversity of Texas at Dallas
2 Previous Clinical Trials
50 Total Patients Enrolled
Jane Wigginton, MDPrincipal InvestigatorUniversity of Texas Southwestern Medical Center
3 Previous Clinical Trials
70 Total Patients Enrolled
Michael Foreman, MD FACSPrincipal InvestigatorBaylor Health Care System
1 Previous Clinical Trials
20 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am between 18 and 64 years old.I do not have major health issues like kidney failure or uncontrolled diabetes.I have an immunodeficiency or have been on drugs affecting my immune system in the last 6 months.You are currently feeling extremely sad and have thoughts of hurting yourself or have recently tried to hurt yourself.I have been diagnosed with chronic PTSD for over 3 months.I do not speak English.I am a suitable candidate for a vagus nerve stimulator implant.My symptoms are very severe, with a PSSI-5 score of 46 or more.I have health issues that make surgery risky for me.I don't have severe circulation issues that could affect a device being implanted.You have psychological conditions like schizophrenia, bipolar disorder, or psychosis that could make it difficult for you to participate in and keep up with the study.You are currently addicted to drugs or alcohol.I have significant brain injuries.I am willing and able to follow all study rules and be available for its duration.I have had or am currently undergoing vagus nerve stimulation treatment.I currently have active cancer.I am not on any treatments that would affect VNS therapy.You are currently receiving prolonged exposure therapy from another provider.You have had previous damage to your vagus nerve.
Research Study Groups:
This trial has the following groups:- Group 1: Vagus Nerve Stimulation + Prolonged Exposure Therapy
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Post-Traumatic Stress Disorder Patient Testimony for trial: Trial Name: NCT04064762 — N/A