RECRUITINGINTERVENTIONAL
Vagal Nerve Stimulation in mTBI
Non-Invasive Vagal Nerve Stimulation in Veterans With Mild Traumatic Brain Injury (mTBI)
About This Trial
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.
Who May Be Eligible (Plain English)
Who May Qualify:
- Veterans with mTBI and PTSD
Who Should NOT Join This Trial:
- 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 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 MRI or CT
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
Inclusion Criteria:
* Veterans with mTBI and 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 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 MRI or CT
Treatments Being Tested
DEVICE
sham stimulation
non invasive vagal nerve stimulation
DEVICE
nVNS
active vns stimulation
Locations (1)
Atlanta VA Medical and Rehab Center, Decatur, GA
Decatur, Georgia, United States