rTMS Target Identification for Functional Disability in AUD+mTBI

NCT04043442 | Enrolling By Invitation Phase 2 FDA Device

• 2 other identifiers: D2916-RI01RX002916
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Alcohol Use Disorder; Mild Traumatic Brain Injury

Outcome Measures

Primary Outcomes (1)

• World Health Organization Disability Assessment Schedule 2.0 (WHODAS) Change

  36-item self report measure of global functional disability. We will use the complex scoring method which creates a summary score into a metric ranging from 0 to 100 (where 0 = no disability; 100 = full disability).

  baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks, 6 months

Study Arms (4)

Active + Placebo rTMS for Custom Neural Target Group 1

ACTIVE COMPARATOR

Custom neural anatomical target 1 defined by neuroimaging data

Device: Magventure MagProX100 with MagOption stimulator and Magpro Cool Coil B65 A/P

Active + Placebo rTMS for Custom Neural Target Group 2

ACTIVE COMPARATOR

Custom neural anatomical target 2 defined by neuroimaging data

Device: Magventure MagProX100 with MagOption stimulator and Magpro Cool Coil B65 A/P

Active + Placebo rTMS for Custom Neural Target Group 3

ACTIVE COMPARATOR

Custom neural anatomical target 3 defined by neuroimaging data

Device: Magventure MagProX100 with MagOption stimulator and Magpro Cool Coil B65 A/P

Active + Placebo rTMS for Left DLPFC Neural Target

ACTIVE COMPARATOR

Neural anatomical target will be the Left Dorsolateral Prefrontal Cortex identified using the 5cm from the motor "hot spot" rule.

Device: Magventure MagProX100 with MagOption stimulator and Magpro Cool Coil B65 A/P

Interventions

Magventure MagProX100 with MagOption stimulator and Magpro Cool Coil B65 A/P DEVICE

rTMS device

Also known as: rTMS device

Active + Placebo rTMS for Custom Neural Target Group 1; Active + Placebo rTMS for Custom Neural Target Group 2; Active + Placebo rTMS for Custom Neural Target Group 3; Active + Placebo rTMS for Left DLPFC Neural Target

Eligibility Criteria

• Age: 22 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Edward Hines Jr. VA Hospital, Hines, IL

Hines, Illinois, 60141-3030, United States

Location

Related Publications (1)

• Herrold AA, Aaronson AL, Bhaumik D, Durazzo T, Livengood SL, Ramic A, Riordan P, Jordan N, Parrish T, Mallinson T, Kale IO, Billups A, Krese K, Kletzel S, Philip NS, Bender Pape TL. A Customized Neural Transcranial Magnetic Stimulation Target for Functional Disability Among Veterans With Co-Occurring Alcohol Use Disorder and Mild Traumatic Brain Injury: Protocol for a Pilot Randomized Controlled Trial. JMIR Res Protoc. 2025 Jun 23;14:e64909. doi: 10.2196/64909.

  PMID: 40550124 DERIVED

MeSH Terms

Conditions

Alcoholism; Brain Concussion

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Brain Injuries, Traumatic; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating

Study Officials

• Amy A Herrold, PhD BA

  Edward Hines Jr. VA Hospital, Hines, IL

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Single Blind. A single blind will be maintained. Veterans will not know when they are receiving which treatment. Researchers will be unblinded to treatment order. rTMS Device and Blinding Procedures. PLACEBO and ACTIVE rTMS will be delivered with the Magventure MagProX100 with MagOption stimulator and Magpro Cool Coil B65 A/P, which can be switched to active or placebo (A/P). The PLACEBO rTMS looks, sounds, and feels like ACTIVE rTMS. Each rTMS treater will be assigned a specific site of stimulation (Group 1, 2, 3, or 4) and will be blinded to the anatomical location of the other 3 sites. rTMS treaters and assessment administrators will be different people for each participant.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Magventure MagProX100 with MagOption stimulator and Magpro Cool Coil B65 A/P and Magpro C-B60

Study Record Dates

• First Submitted: July 31, 2019
• First Posted: August 2, 2019
• Study Start: January 1, 2019
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): March 31, 2027
• Last Updated: April 8, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Three years after study completion or after all primary papers have been accepted for publication.
• Access Criteria: Federal Interagency Traumatic Brain Injury Research Informatics System.

Locations

US (1)