NCT05517304 Transcutaneous Vagal Nerve Stimulation in Veterans With Posttraumatic Stress Disorder
| NCT ID | NCT05517304 |
| Status | Recruiting |
| Phase | — |
| Sponsor | VA Office of Research and Development |
| Condition | Stress Disorders, Post-Traumatic |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2022-10-01 |
| Primary Completion | 2027-07-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 80 participants in total. It began in 2022-10-01 with a primary completion date of 2027-07-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 between the ages of 18 and 75 will be included with a diagnosis of 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 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
Contact & Investigator
Doug J Bremner, MD
PRINCIPAL INVESTIGATOR
Atlanta VA Medical and Rehab Center, Decatur, GA
Frequently Asked Questions
Who can join the NCT05517304 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Stress Disorders, Post-Traumatic. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05517304 currently recruiting?
Yes, NCT05517304 is actively recruiting participants. Contact the research team at James.Bremner@va.gov for enrollment information.
Where is the NCT05517304 trial being conducted?
This trial is being conducted at Decatur, United States.
Who is sponsoring the NCT05517304 clinical trial?
NCT05517304 is sponsored by VA Office of Research and Development. The principal investigator is Doug J Bremner, MD at Atlanta VA Medical and Rehab Center, Decatur, GA. The trial plans to enroll 80 participants.