NCT06415721 · VA Palo Alto Health Care System
Developing Functional Connectivity-Guided TMS for Alcohol Use Disorder
What this study is about
Alcohol Use Disorders are currently positioned as the third leading cause of preventable death in the United States, constituting a humanitarian crisis with substantial financial burden on society and medical facilities. While several pharmacological interventions exist, 60% of individuals who seek these treatments relapse to alcohol within 6 months.
View original scientific description
Alcohol Use Disorders are currently positioned as the third leading cause of preventable death in the United States, constituting a humanitarian crisis with substantial financial burden on society and medical facilities. While several pharmacological interventions exist, 60% of individuals who seek these treatments relapse to alcohol within 6 months. These high relapse rates are due in part to elevated brain response to alcohol cues in the environment. This study seeks to evaluate the efficacy of one session of functional Magnetic Resonance Imaging (fMRI) guided transcranial magnetic stimulation (TMS) as a strategy to reduce brain reactivity to alcohol cues.
Interventions
DEVICE
Active Transcranial Magnetic Simulation
1 session of active continuous theta burst stimulation (3600 pulses, 110% RMT) will be delivered to the cortical region demonstrating maximal functional connectivity with the striatum during alcohol cue presentation. TMS will be delivered using the Magventure MagPro X100.
DEVICE
Sham
1 session of sham continuous theta burst stimulation (3600 pulses, 110% RMT) will be delivered to the cortical region demonstrating maximal functional connectivity with the striatum during alcohol cue presentation. The MagVenture MagPro x100 is capable of administering a sham stimulation. The reverse side of the TMS coil is plated with a magnetic shield such that electromagnetic energy cannot stimulate the brain. The device offers compatibility with Transcutaneous Electrical Nerve Stimulation devices such that titrated electrical pulses can be delivered to the scalp location to mimic the sensation of a TMS pulse without stimulating the brain.
Primary outcome measures
Change in blood-oxygen level dependent signal as a measure of change in alcohol cue reactivity
Time frame: Baseline (pre-TMS) and Day 2 (post-TMS)
The effect of real versus sham fMRI-guided TMS on alcohol cue reactivity will be assessed by comparing brain reactivity to images of alcohol ('alcohol cues') shown during the fMRI scan. Change in blood-oxygen level dependent signal magnitude will be measured within the striatum, a key brain region involved in cue-reactivity.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Between age 25 and 75.
- Current DSM-5 diagnosis of moderate to severe AUD (≥4 diagnostic symptoms).
- Able to attend scheduled clinic visits
- Able to read, understand and voluntarily sign Informed Consent prior to participating in any study-specific procedures or assessments.
- If on a medication regimen, that regimen will be stable for the duration of the study;
- Fluency in English.
Exclusion criteria
- Transcranial magnetic stimulation (TMS) and magnetic resonance imaging (MRI) contraindications: such as a cardiac pacemaker, cochlear implant, or an implanted device (deep brain stimulation, metal in the head, metal in the body, claustrophobia, pregnant or breastfeeding or other ferromagnetic device/objected in the head and body within 30 cm of the treatment coil.
- General medical condition, disease or neurological disorder that interferes with the assessments or participation.
- Unable to safely withdraw, at least two weeks prior to treatment, from medications that increase seizure risk.
- Current substance abuse (except caffeine or nicotine) as determined by positive toxicology screen.
- Have a mass lesion, cerebral infarct, or other active CNS disease, including an alcohol-related seizure or a seizure disorder. • A recent suicide attempt (defined as within the last 30 days) or presence of current suicidal plan or intent. Patients at risk for suicide will be required to establish a written safety plan involving their primary therapist before entering the study.
- Severe impediment to vision, hearing and/or hand movement, likely to interfere with the ability to follow study protocols. • Greater than mild traumatic brain injury (defined as greater than 10 minutes loss of consciousness).
- Taking benzodiazepine or neuroleptic medications, or any medication known to alter seizure threshold
- unstable chronic illness.
- Current or lifetime history of bipolar disorder or psychosis.
- Participation in another concurrent intervention based clinical trial.
Where
- Palo Alto, California
Collaborators
Stanford University, National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 13, 2025 · Source of record for eligibility and locations