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New treatment option for Stress Disorders, Post-Traumatic
Official title Transcutaneous Vagal Nerve Stimulation in Veterans With Posttraumatic Stress Disorder
ClinicalTrials.gov ID: NCT05517304
What this study is testing
- What it's testing
- This study effects the effects of transcutaneous cervical vagal nerve stimulation (tcVNS) or a sham control on brain, physiology, and PTSD symptoms in Veterans with posttraumatic stress disorder (PTSD). Veterans undergo brain imaging and physiological measures in conjunction with traumatic scripts before and after three months of twice daily treatment with tcVNS or sham stimulation at home.
- This is a blinded study.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Veterans between the ages of 18 and 75 will be included with a diagnosis of PTSD based on DSM-5 criteria
You likely can't join if
- people will be excluded with:
- a history of mild traumatic brain injury (mTBI) based on VA Criteria
- moderate or greater TBI
- positive pregnancy test
- meningitis or other neurological disorder
- alcohol or substance abuse use disorder based on DSM-5 criteria within the past 12 months
See the full eligibility criteria
- Veterans between the ages of 18 and 75 will be included with a diagnosis of PTSD based on DSM-5 criteria
- people will be excluded with:
- a history of mild traumatic brain injury (mTBI) based on VA Criteria
- moderate or greater TBI
- positive pregnancy test
- meningitis or other neurological disorder
- alcohol or substance abuse use disorder based on DSM-5 criteria within the past 12 months
- current or lifetime history of schizophrenia, schizoaffective disorder, bipolar I disorder, anorexia nervosa or bulimia, based on DSM-5
- active suicidal ideation with a plan
- a history of serious medical or neurological illness, such as cardiovascular, gastrointestinal, hepatic, renal, neurologic or other systemic illness that would preclude participation based on clinical judgment of the PI
- active opiate or benzodiazepine treatment
- history of structural abnormality on brain MRI or CT if one has been performed in the past
The study team makes the final eligibility decision.
Where it's taking place
- Decatur, Georgia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Decatur, Georgia, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.