Accepted for/Published in: JMIR Research Protocols
Date Submitted: Dec 20, 2024
Date Accepted: Mar 24, 2025
Customized neural TMS target for functional disability among Veterans with co-occurring alcohol use disorder and mild traumatic brain injury: Protocol for TMS TARGET for AUD+mTBI Pilot Randomized Controlled Trial
ABSTRACT
Background:
Alcohol use disorder and mild traumatic brain injury (AUD+mTBI) commonly co-occur resulting in exacerbation of symptoms, and negatively impacting function. The co-occurrence of AUD+mTBI theoretically represents a unique and heterogenous brain state that impacts symptoms and function. Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive neuromodulatory treatment with burgeoning evidence for improving brain function and symptoms for AUD and mTBI each alone. However, there is no consensus on optimal neural target or treatment site of stimulation for either of these conditions alone, or when they co-occur.
Objective:
1) Test preliminary efficacy of high-frequency rTMS provided to a customized neural target or site of stimulation to treat functional disability among Veterans with AUD+mTBI. 2) Assess sustainability of rTMS effects on functional disability for Veterans with AUD+mTBI.
Methods:
This is a single-blind, RCT including Veterans with AUD+mTBI. Veterans will be randomized to one of 2 groups: (1) novel TMS target site of stimulation using neuronavigation and (2) standard clinical left DLPFC using the Beam F3 method. All participants first receive 10 sessions (1 session/day) sham rTMS followed by 10 sessions (1 session/day) active rTMS (10Hz). Veterans will complete study outcomes pre- and post- sham and active session blocks as well as at 2-week, 1-month, 3-month and 6-month post-treatment follow-up timepoints. The primary outcome is the World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0). Secondary outcomes include the following: alcohol use on the Timeline Followback (TLFB) Calendar, Penn alcohol Craving Scale (PACS), Obsessive Compulsive Drinking Scale (OCDS), Alcohol Craving Questionnaire (ACQ-NOW), Neurobehavioral Symptom Inventory (NSI), PTSD Checklist for DSM-5 (PCL-5), Beck Depression Inventory-II (BDI-II), Beck Anxiety Inventory (BAI), Mood and Anxiety Symptom Questionnaire (MASQ).
Results:
This study protocol was approved by Edward Hines Jr. Veterans Administration Hospital Institutional Review Board (Hines IRB 19-021). This study protocol as prospectively registered on ClinicalTrials.gov (NCT04043442). This study includes a Food and Drug Administration Investigational Device Exemption (IDE: G180292). A 6-year research plan timeline was developed including cost/no-cost extensions due to the COVID-19 pandemic. As of August 2024, a total of 27 Veterans with AUD+mTBI are enrolled in the study and completed the neural target identification phase and are awaiting enrollment in the RCT phase. Data collection is ongoing and will be completed by May 2026. We expect the results of this study to be available by May 2027.
Conclusions:
We will be able to provide preliminary evidence of efficacy as well as safety and feasibility, of a novel TMS target site of stimulation for improving functional disability for Veterans with co-occurring AUD+mTBI. Clinical Trial: ClinicalTrials.gov NCT04043442 https://clinicaltrials.gov/study/NCT04043442?tab=results
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