Deep TMS targeting salience-network brain circuits to reduce relapse in Veterans with alcohol use disorder
Accessing the Impact of Deep TMS Neuromodulation on Neural Circuits Associated With Alcohol Use Disorder
This trial tests whether deep transcranial magnetic stimulation (dTMS) aimed at salience-network targets can help Veterans with moderate to severe alcohol use disorder stay abstinent and lower relapse risk.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Stanford University Academic / other |
| Locations | 1 site (Palo Alto, California) |
| Trial ID | NCT06949423 on ClinicalTrials.gov |
What this trial studies
Veteran participants with moderate-to-severe alcohol use disorder receive either active or sham deep transcranial magnetic stimulation (dTMS) using an H7 coil, combined with neuroimaging before and after the treatment course. The protocol targets deep cortical nodes in the salience network, including the dorsal anterior cingulate cortex (dACC), to produce measurable changes in activation and connectivity. Clinical outcomes such as abstinence and relapse rates are tracked alongside neural measures to link brain changes with behavior. The design tests whether modulation of identified neural targets produces durable reductions in relapse risk among Veterans.
Who should consider this trial
Good fit: Ideal candidates are Veterans aged 18–75 with a DSM-5 diagnosis of moderate-to-severe alcohol use disorder who can undergo TMS and MRI, have a stable living/medication situation, and can attend clinic visits at the study site.
Not a fit: Patients with contraindications to TMS or MRI (for example pacemakers, certain implants, pregnancy), unstable medical or psychiatric conditions, or those unable to attend repeated clinic visits are unlikely to be eligible and therefore unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, this approach could lower relapse rates and improve sustained abstinence by normalizing salience-network function in Veterans with AUD.
How similar studies have performed: Preclinical work and early clinical neuromodulation studies targeting the dACC and salience network have produced promising neural and behavioral signals, but large randomized trials are still limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 18-75. * Current DSM-5 diagnosis of moderate to severe AUD (\≥4 diagnostic symptoms). * Ability to obtain a Motor Threshold (MT) will be determined during the screening process. * Has an adequately stable condition and environment to enable attendance at scheduled clinic visits. * Able to read, understand and voluntarily sign the Informed Consent Form prior to participating in any study-specific procedures or assessments. * If on a medication regimen for comorbid symptoms, that regimen will be stable for the duration of the study and patient will be willing to remain on this regimen during the treatment phase. * 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 * Acute or unstable chronic illness. * Current or lifetime history of bipolar disorder or psychosis
Where this trial is running
Palo Alto, California
- VA Palo Alto Health Care System — Palo Alto, California, United States (Recruiting)
Study contacts
- Principal investigator: Claudia B Padula, PhD — Stanford University
- Study coordinator: Samantha J Ward, BS
- Email: samward@stanford.edu
- Phone: 650-493-5000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.