rTMS Target Identification for Functional Disability in AUD+mTBI

Enrolling by invitation · Phase 2 · Has a placebo group

Conditions studied: Alcohol Use Disorder, Mild Traumatic Brain Injury

In brief

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 efficacy of this target as a stimulation site for repetitive transcranial magnetic stimulation (rTMS) treatment to maximize functional recovery. rTMS will soon be a treatment option at 30 VAs nationwide and preliminary studies show promise for AUD and mTBI treatment. A better understanding of how AUD+mTBI impacts the brain needs to occur in order to advance rTMS to optimize function. This research is aligned with the VA RR\&D's mission to generate knowledge and innovations to advance the rehabilitative health and care of Veterans, to effectively integrate clinical and applied rehabilitation research, and translate research results into practice. This research is also aligned with the goal of the Psychological Health \& Social Reintegration portfolio to develop interventions improving psychological health status of Veterans enabling them to function more fully in society.

Key facts

Study ID

NCT04043442

Run by

VA Office of Research and Development

People needed

100

Starts

2019-01-01

Expected to finish

2027-03-31

Last updated by the study team

2026-04-08

Who can join

Age: 22 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Edward Hines Jr. VA Hospital, Hines, IL — Hines, Illinois, United States

Full record on ClinicalTrials.gov

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