RecruitingNot ApplicableNCT05517304
Transcutaneous Vagal Nerve Stimulation in Veterans With Posttraumatic Stress Disorder
Sponsor
VA Office of Research and Development
Enrollment
80 participants
Start Date
Oct 1, 2022
Study Type
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Min Age: 18 YearsMax Age: 75 Years
Inclusion Criteria1
- Veterans between the ages of 18 and 75 will be included with a diagnosis of PTSD based on DSM-5 criteria
Exclusion Criteria11
- Subjects 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
Interventions
DEVICEtcVNS
Active stimulation with transcutaneous Vagal Nerve Stimulation (tcVNS)
DEVICESham
Sham stimulation
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT05517304
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