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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
Awards & highlights

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.Check my eligibility
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.See study design
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:
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I have a history of heart or blood vessel disease.
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I am taking medication that affects my nervous system.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
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
~110

Find a Location

Who is running the clinical trial?

US Department of Veterans AffairsFED
871 Previous Clinical Trials
497,847 Total Patients Enrolled
24 Trials studying Hypertension
50,436 Patients Enrolled for Hypertension
Emory UniversityLead Sponsor
1,655 Previous Clinical Trials
2,572,383 Total Patients Enrolled
31 Trials studying Hypertension
13,724 Patients Enrolled for Hypertension
Jeanie Park, MDPrincipal Investigator - Emory University and the Atlanta VA Medical Center
Emory University Hospital, Emory University Hospital Midtown, Select Specialty Hospital-Atlanta
University Of Alabama School Of Medicine (Medical School)
4 Previous Clinical Trials
474 Total Patients Enrolled

Media Library

Device-Guided Breathing (DGB) (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT01627301 — N/A
Hypertension Research Study Groups: Sham DGB, Device-guided Breathing (DGB), Transcutaneous Vagal Nerve Stimulation (tVNS), Sham tVNS
Hypertension Clinical Trial 2023: Device-Guided Breathing (DGB) Highlights & Side Effects. Trial Name: NCT01627301 — N/A
Device-Guided Breathing (DGB) (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01627301 — N/A
~3 spots leftby Dec 2024