RECRUITING

Transcutaneous Vagal Nerve Stimulation in Veterans With Posttraumatic Stress Disorder

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Conditions

Stress Disorders, Post-TraumaticPTSDVagus Nerve

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Transcutaneous Vagal Nerve Stimulation in Veterans With Posttraumatic Stress Disorder

Quick Facts

Study Start:2022-10-01
Study Completion:2026-09-15
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05517304

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Veterans between the ages of 18 and 75 will be included with a diagnosis of PTSD based on DSM-5 criteria
  1. * a history of mild traumatic brain injury (mTBI) based on VA Criteria
  2. * moderate or greater TBI
  3. * positive pregnancy test
  4. * meningitis or other neurological disorder
  5. * alcohol or substance abuse use disorder based on DSM-5 criteria within the past 12 months
  6. * current or lifetime history of schizophrenia, schizoaffective disorder, bipolar I disorder, anorexia nervosa or bulimia, based on DSM-5
  7. * active suicidal ideation with a plan
  8. * 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
  9. * active opiate or benzodiazepine treatment
  10. * history of structural abnormality on brain MRI or CT if one has been performed in the past

Contacts and Locations

Study Contact

Doug J Bremner, MD
CONTACT
(404) 712-9569
James.Bremner@va.gov

Principal Investigator

Doug J Bremner, MD
PRINCIPAL_INVESTIGATOR
Atlanta VA Medical and Rehab Center, Decatur, GA

Study Locations (Sites)

Atlanta VA Medical and Rehab Center, Decatur, GA
Decatur, Georgia, 30033-4004
United States

Collaborators and Investigators

Sponsor: VA Office of Research and Development

  • Doug J Bremner, MD, PRINCIPAL_INVESTIGATOR, Atlanta VA Medical and Rehab Center, Decatur, GA

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-10-01
Study Completion Date2026-09-15

Study Record Updates

Study Start Date2022-10-01
Study Completion Date2026-09-15

Terms related to this study

Keywords Provided by Researchers

  • Stress Disorders, Post-Traumatic
  • PTSD
  • Vagus Nerve

Additional Relevant MeSH Terms

  • Stress Disorders, Post-Traumatic