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Alcohol Use DisorderPhase 2rTMS-TARGET-IDNCT04043442

rTMS Target Identification for Functional Disability in AUD+mTBI

A Phase 2 study testing Magventure MagProX100 with MagOption stimulator and Magpro Cool Coil B65 A/P in people with Alcohol Use Disorder and Mild Traumatic Brain Injury, run by VA Office of Research and Development at 1 site in United States.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 22 to 65 years
What is being tested?
Magventure MagProX100 with MagOption stimulator and Magpro Cool Coil B65 A/P
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteUnited States
Study dates
1 Jan 2019to 31 Mar 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 22 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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
Show all 9Show fewer
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site
  • Edward Hines Jr. VA Hospital, Hines, IL

    Hines, Illinois, 60141-3030

Other trials in United States

About this study

Official title: Neural Target Identification for Functional Disability Associated With Alcohol Related Characteristics Among Veterans With Co-occurring Alcohol Use Disorder and Traumatic Brain Injury

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.

Read the 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+mTBI) leads to an exacerbation of brain dysfunction, symptom manifestation, and ultimately, functional disability. Alcohol-related characteristics are operationally defined per AUD symptoms and outcomes including, but not limited to, alcohol consumption, alcohol craving, and AUD severity. Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive neuromodulatory treatment that will soon be a treatment option at 30 VAs nationwide. Preliminary rTMS efficacy is demonstrated for AUD alone and mTBI alone using a variety of neural targets. rTMS is, thus, a promising treatment for AUD+mTBI. The objectives of this study are to 1) identify neural targets (i.e. site of stimulation) associated with both alcohol-related characteristics and self-reported functional disability, and 2) assess preliminary efficacy and sustainability of a high frequency rTMS protocol applied to these customized neural targets relative to the commonly used left dorsolateral prefrontal cortex (DLPFC) site. Addressing these objectives are essential steps towards the long-term research goal [to customize and clinically implement a rTMS treatment] that can improve brain function resulting in optimal recovery for Veterans with AUD+mTBI. To address the first study objective, Veterans will be recruited and classified into one of two groups based on structured-interviews, self-report measures, and neuropsychological assessments: 1) AUD+mTBI, and 2) [Veteran controls] without a history or symptoms of mTBI or AUD. Alcohol-related characteristics will be assessed through objective measures of alcohol use, self-report measures, and structured interviews. Self-reported functional disability will be assessed using the World Health Organization Disability Assessment Schedule 2.0 (WHODAS). Neuroimaging metrics will be assessed through a multi-modal, functional and structural Magnetic Resonance Imaging (MRI) scan. Participants will complete a functional MRI (fMRI) protocol where brain activation will be measured in response to viewing images related to alcohol, compared to neutral images. Advanced neuroimaging procedures to determine the structural integrity of white matter fibers in the brain and spontaneous activity in brain networks, a process called resting state functional connectivity (rsFC), will also be conducted. To address the second study objective, AUD+mTBI Veterans will receive rTMS at one site randomly assigned from a set of 4 sites: 3 customized neural targets identified in this study, and the commonly used left DLPFC. AUD+mTBI Veterans will complete 10 PLACEBO, then 10 ACTIVE rTMS sessions in a within-subjects design. Follow-up WHODAS assessments will occur at 2-weeks, 1-month and 6-months post-ACTIVE rTMS. Aim 1 will identify unique neural targets for rTMS to treat AUD+mTBI by determining which multi-modal neuroimaging metrics are most strongly associated with both alcohol-related characteristics and functional disability. Aim 2 will [test preliminary efficacy of high-frequency rTMS administered over the customized neural targets] to treat functional disability among Veterans with AUD+mTBI. Aim 3 will assess sustainability of rTMS effects on functional disability for Veterans with AUD+mTBI. The investigators hypothesize that for Veterans with AUD+mTBI, there are neural substrates of AUD related to functional disability, and that neuromodulation of these substrates will be related to gains in functional disability. The investigators' innovative approach represents an advancement in the field of neurorehabilitation because a neural target will be systematically defined, using multi-modal neuroimaging, prior to preliminary rTMS efficacy and sustainability testing. These steps are necessary to customize rTMS treatment for a population of Veterans with co-occurring conditions and unique health care needs. Thus, the outcomes of this research will optimize function for Veterans with AUD+mTBI.

Being tested
Magventure MagProX100 with MagOption stimulator and Magpro Cool Coil B65 A/P
Medical subject headings
Alcoholism, Brain Concussion

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Magventure MagProX100 with MagOption stimulator and Magpro Cool Coil B65 A/PDevice

    Also called rTMS device

    rTMS device

Study groups in NCT04043442
Study groupRoleWhat they receive
Active + Placebo rTMS for Custom Neural Target Group 1Active comparatorCustom neural anatomical target 1 defined by neuroimaging data
Receives: Device: Magventure MagProX100 with MagOption stimulator and Magpro Cool Coil B65 A/P
Active + Placebo rTMS for Custom Neural Target Group 2Active comparatorCustom neural anatomical target 2 defined by neuroimaging data
Receives: Device: Magventure MagProX100 with MagOption stimulator and Magpro Cool Coil B65 A/P
Active + Placebo rTMS for Custom Neural Target Group 3Active comparatorCustom neural anatomical target 3 defined by neuroimaging data
Receives: Device: Magventure MagProX100 with MagOption stimulator and Magpro Cool Coil B65 A/P
Active + Placebo rTMS for Left DLPFC Neural TargetActive comparatorNeural anatomical target will be the Left Dorsolateral Prefrontal Cortex identified using the 5cm from the motor "hot spot" rule.
Receives: Device: Magventure MagProX100 with MagOption stimulator and Magpro Cool Coil B65 A/P

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Aug 2019
  2. Study start1 Jan 2019
  3. Primary completion31 Mar 2027 (estimated)
  4. Study completion31 Mar 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Magventure MagProX100 with MagOption stimulator and Magpro Cool Coil B65 A/P and Magpro C-B60
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04043442
Sponsor's protocol ID
D2916-R
Other IDs
I01RX002916
Acronym
rTMS-TARGET-ID
Status last verified
Apr 2026
First submitted
31 Jul 2019
Last updated
8 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
Yes: A de-identified, anonymized dataset will be created and shared. MRI images will anonymized and made available through the Northwestern University Neuroimaging Data Archive (NUNDA). Final data sets will be made available as per Hines VA Hospital local policy for long term storage and access until enterprise-level resources become available. These data will be available upon request by researchers and scientists in accordance with federal guidelines and Hines local policy.The data provided will be sufficient for anyone to perform analogous or supplemental analyses that would permit validation of the analysis and results. The sharing of data will enable others to evaluate the data and to validate and interpret the data independently. In order to insure that replication is possible and transparency, statistical code complementary to datasets will be made available through the Federal Interagency Traumatic Brain Injury Research Informatics System.

Publications

  • 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.

    PubMed 40550124

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Magventure MagProX100 with MagOption stimulator and Magpro Cool Coil B65 A/P in people with Alcohol Use Disorder and Mild Traumatic Brain Injury, run by VA Office of Research and Development at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 8 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

World Health Organization Disability Assessment Schedule 2.0 (WHODAS) Change (time frame: baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks, 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04043442, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2026.

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