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Completed
NCT05517304
Transcutaneous Vagal Nerve Stimulation in Veterans With Posttraumatic Stress Disorder
Conditions: Stress Disorders, Post-Traumatic
Sex: All
Ages: 18 Years – 75 Years
Healthy volunteers: No
Phase: NA
Enrollment: 23
Sponsor: VA Office of Research and Development
Location: Atlanta VA Medical and Rehab Center, Decatur, GA Decatur Georgia
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 Criteria
Inclusion Criteria:
* Veterans will be included with a diagnosis of post-traumatic stress disorder (PTSD) based on DSM-5 criteria
Exclusion Criteria:
Subjects will be excluded with:
* a history of mild traumatic brain injury (mTBI) based on VA Criteria
* moderate or greater traumatic brain injury
* 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 magnetic resonance imaging (MRI) or computerized tomography (CT) if one has been performed in the past
Source: ClinicalTrials.gov (NCT05517304). StuddyBuddy aggregates publicly available trial information.