Status:
ENROLLING_BY_INVITATION
rTMS Target Identification for Functional Disability in AUD+mTBI
Lead Sponsor:
VA Office of Research and Development
Conditions:
Alcohol Use Disorder
Mild Traumatic Brain Injury
Eligibility:
All Genders
22-65 years
Phase:
PHASE2
Brief Summary
The objectives of this VA Merit application are to identify a neural target unique to Veterans with co-occurring alcohol use disorder and mild traumatic brain injury (AUD+mTBI) and to test the efficac...
Detailed Description
Alcohol use disorder (AUD) and mild traumatic brain injury (mTBI) impact functional abilities. AUD occurs in up to 35% of Veterans with mTBI. Evidence suggests that co-occurrence of AUD and mTBI (AUD+...
Eligibility Criteria
Inclusion
- Can read and speak English
- Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria for AUD
- Symptom Attribution and Classification (SACA) criteria (Pape, Herrold et al 2016, JHTR) for mTBI (without requirement of clinical neuropsychological impairment)
Exclusion
- History of moderate to severe TBI
- Neurodegenerative disease (e.g., Alzheimer's disease, Parkinson's disease, multiple sclerosis)
- History of or current psychotic spectrum disorders (i.e., schizophrenia, schizoaffective and bipolar disorders)
- Intellectual disability (WTAR predicted full-scale IQ score \< 70)42
- Are pregnant or nursing
- Use of benzodiazepines, opiates, cocaine, or amphetamines in the past 30 days
- Meet DSM-5 criteria for moderate to severe cannabis use disorder
- Contraindications to MRI (e.g., claustrophobia, ferromagnetic metal in eyes or face, congestive heart failure, implanted cardiac pacemaker or defibrillator, cochlear implant, nerve stimulator)
- Meet SACA criteria for 'Questionable Validity' of performance effort and symptom reporting
Key Trial Info
Start Date :
January 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2026
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04043442
Start Date
January 1 2019
End Date
March 31 2026
Last Update
March 18 2025
Active Locations (1)
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1
Edward Hines Jr. VA Hospital, Hines, IL
Hines, Illinois, United States, 60141-3030