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Completed NCT04437498

Vagal Nerve Stimulation in mTBI

Conditions: PTSD, mTBI

Sex: All
Ages: 18 Years – 55 Years
Healthy volunteers: No
Phase: NA
Enrollment: 28
Sponsor: VA Office of Research and Development

Location: Atlanta VA Medical and Rehab Center, Decatur, GA Decatur Georgia

Summary

Mild traumatic brain injury (mTBI) and posttraumatic stress disorder (PTSD) are important conditions for the Veterans Administration (VA) that frequently occur together in combat Veterans from the conflicts in Afghanistan and Iraq. In many Veterans these become chronic, raising the risk the burden of neurotrauma can worsen over time. This study will examine a new intervention called non-invasive Vagal Nerve Stimulation (nVNS) and its effects on memory and symptoms of PTSD and mTBI as well as brain and physiology in Veterans with mTBI and PTSD.

Eligibility Criteria

Inclusion Criteria: * Veterans with Mild Traumatic Brain Injury (mTBI) and post-Traumatic Stress Disorder (PTSD) Exclusion Criteria: * amnesia for the inciting event lasted longer than 24 hours * Glasgow Coma Scale Score after 30 minutes was less than 13 * loss of consciousness more than 30 minutes * positive pregnancy test * meningitis or other neurological disorder other than Mild Traumatic Brain Injury (mTBI) * alcohol or substance abuse use disorder based on the SCID within the past 12 months * current or lifetime history of schizophrenia, schizoaffective disorder, bipolar disorder, anorexia nervosa or bulimia, based on the SCID * active suicidal ideation based on criteria outlined below * a history of serious medical or neurological illness, such as cardiovascular, gastrointestinal, hepatic, renal, neurologic or other systemic illness * active neuroleptic, opiate, or benzodiazepine treatment * structural abnormality on brain magnetic resonance imaging (MRI) or computed tomography (CT)

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT04437498). StuddyBuddy aggregates publicly available trial information.