← Back to Search

Behavioural Intervention

DGB + tVNS for Post-Traumatic Stress Disorder (SO-PTSD Trial)

N/A

Recruiting

Led By Jeanie Park, MD

Research Sponsored by Emory University

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Must not have

History of heart or vascular disease

Use of medications known to affect sympathetic nervous system (SNS) (e.g., clonidine)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, week 8

Summary

This trial will test whether two treatments, DGB therapy and transcutaneous vagus nerve stimulation (tVNS) therapy, can help improve symptoms of post-traumatic stress disorder (PTSD).

Who is the study for?

This trial is for prehypertensive and normotensive veterans with or without PTSD, aiming to study the effects of certain therapies on their nervous system. Pregnant individuals, those with serious systemic diseases, heart or vascular disease, autonomic dysfunction, excessive alcohol use, illicit drug users, and people on specific SNS-affecting medications or recent MAO inhibitors cannot participate.

What is being tested?

The study tests if 8 weeks of daily Device-Guided Breathing (DGB) therapy or Transcutaneous Vagal Nerve Stimulation (tVNS) can improve sympathetic nervous system activity in veterans with PTSD. It includes control interventions like Sham tVNS and Sham DGB to compare results against.

What are the potential side effects?

Potential side effects from DGB are minimal but may include discomfort due to breathing patterns. tVNS might cause local irritation at the stimulation site or slight headaches. However, these therapies are generally considered low-risk.

Eligibility Criteria

Exclusion Criteria

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

Select...

I have a history of heart or blood vessel disease.

Select...

I am taking medication that affects my nervous system.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, week 8

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, week 8

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 8 for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Change in BRS While Under Mental Stress

Change in Baroreflex Sensitivity (BRS) at Rest

Change in MSNA Burst Frequency While Under Mental Stress

+1 more

Secondary study objectives

Endothelial Function

Vascular Stiffness

Trial Design

4Treatment groups

Experimental Treatment

Placebo Group

Group I: Transcutaneous Vagal Nerve Stimulation (tVNS)Experimental Treatment1 Intervention

Participants randomized to use a tVNS device to deliver mild electrical stimulation to the vagal nerve.

Group II: Device-guided Breathing (DGB)Experimental Treatment1 Intervention

Participants randomized to the DGB group use a device to guide their breathing to a slow breathing rate.

Group III: Sham DGBPlacebo Group1 Intervention

Participants randomized to the sham DGB group use a device identical to the DGB device but respiratory rates are not guided lower than the physiological rate.

Group IV: Sham tVNSPlacebo Group1 Intervention

Participants randomized to use the sham tVNS device which vibrates but does not stimulate the vagal nerve.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Transcutaneous Vagal Nerve Stimulation (tVNS)

2019

N/A

~120

0 / 2Eligibility criteria met