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Alcohol Use Disorder (AUD)NEST-ANCT06949423

Assessing the Impact of dTMS on Neural Targets Associated With Alcohol Use Disorder

A study testing Deep Transcranial Magnetic Stimulation (dTMS) H7 coil - Active in people with Alcohol Use Disorder (AUD) and Transcranial Magnetic Stimilation, run by Stanford University at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The purpose of this study is to evaluate the efficacy of deep transcranial magnetic stimulation as a treatment for Veterans with Alcohol Use Disorder (AUD) to decrease the exceedingly high rate of relapse associated with this condition. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Deep Transcranial Magnetic Stimulation (dTMS) H7 coil - Active
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
100 participants
Where
1 siteUnited States
Study dates
17 Dec 2025to 30 Jun 2030
Phase
Interventional
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 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 11Show fewer
  • 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

Trial locations and contacts

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

Eileen G Fischer, BS contact

210-993-2065

grace.fischer@stanford.edu

United States1 site, 1 recruiting
  • VA Palo Alto Health Care System

    Palo Alto, California, 94304

    Eileen G Fischer, BS, 210-993-2065, grace.fischer@stanford.edu

    Claudia B Padula, PhD

    Recruiting

Other trials in United States

About this study

Official title: Accessing the Impact of Deep TMS Neuromodulation on Neural Circuits Associated With Alcohol Use Disorder

The purpose of this study is to evaluate the efficacy of deep transcranial magnetic stimulation as a treatment for Veterans with Alcohol Use Disorder (AUD) to decrease the exceedingly high rate of relapse associated with this condition.

Read the detailed description

Alcohol use disorder (AUD) is a highly prevalent disorder with a chronic relapse-remit cycle, and over 60% of individuals relapse within months of treatment. Preclinical and human research over the last several decades have defined AUD as a neural circuit-based disorder, which are driven by changes in salience network (SN) function. Emerging non-invasive neuromodulation techniques, such as deep transcranial magnetic stimulation (dTMS), can directly modify neural targets that are related to AUD relapse risk, including the SN.

Preclinical and clinical studies have shown that manipulation of deep cortical nodes within the salience network (SN), such as the dorsal anterior cingulate cortex (dACC), can reduce compulsive drinking. Our lab has demonstrated that blunted dACC activation to affective cues predicts relapse - identifying dACC as a promising neuromodulation target. A systematic interrogation of salience network neuromodulation bridges preclinical and clinical research and has the potential to revolutionize AUD treatment. Our preliminary data demonstrates 1) feasibility of the proposed dTMS protocol and 2) promising neural and clinical outcomes. Specifically, those who received this innovative intervention demonstrated increased dACC activation to affective cues from pre- to post-treatment, dynamic changes in functional connectivity and 100% abstinence at follow up.

Building on these data and a theory-driven conceptual framework, the current proposal aims to systematically address three remaining scientific gaps: 1) to what extent does dTMS stimulation of the dACC modify drinking rates and neural targets, 2) can target engagement be a marker of early treatment response, and 3) how long do the effects of dTMS last? This research is significant and innovative as it utilizes a novel, neuromodulation technique to directly manipulate neural networks that drive relapse in AUD.

Being tested
Deep Transcranial Magnetic Stimulation (dTMS) H7 coil - Active, Deep Transcranial Magnetic Stimulation (dTMS) H7 coil - Sham
Keywords
Veterans, Deep Transcranial Magnetic Stimulation (dTMS), Neuroimaging, Relapse
Medical subject headings
Alcoholism, Recurrence

What participants receive

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

  • Deep Transcranial Magnetic Stimulation (dTMS) H7 coil - ActiveDevice

    The study will utilize the H7 coil to administer active Deep Transcranial Magnetic Stimulation (dTMS) to the dorsal anterior cingulate cortex (dACC), a core salience network node.

  • Deep Transcranial Magnetic Stimulation (dTMS) H7 coil - ShamDevice

    The study will utilize an identical protocol using the H7 coil to administer a sham condition.

Study groups in NCT06949423
Study groupRoleWhat they receive
Active dTMSExperimentalParticipants will receive 30 sessions of active-dTMS to the dACC/mPFC with the H7 coil, administered 3 times per day over 10 consecutive business days. Each treatment visit will last approximately 30 minutes in total.
Receives: Device: Deep Transcranial Magnetic Stimulation (dTMS) H7 coil - Active
Sham dTMSSham comparatorParticipants will receive 30 sham dTMS sessions, administered 3 times per day over 10 consecutive business days. Each treatment visit will last approximately 30 minutes in total.
Receives: Device: Deep Transcranial Magnetic Stimulation (dTMS) H7 coil - Sham

What is being measured

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

  1. Change in Dorsal Anterior Cingulate Cortex Function (dACC) Activation During the FACES Task, Measured via fMRI

    dACC activation to threat faces will be measured using fMRI during the FACES task, designed to assess emotional processing. Activation will be quantified as percent signal change from baseline (pre-treatment) to post-treatment scan.

    Measured: 1-4 days post treatment

  2. Percentage of Days Abstinent from Alcohol, Assessed by Timeline Followback (TLFB)

    Alcohol abstinence will be assessed using the TLFB structured interview method. The outcome will be calculated as the percentage of alcohol-free days out of the total number of days in the 3-month follow-up period post-treatment.

    Measured: 3-months post treatment

  3. Percentage of Heavy Drinking Days, Assessed by Timeline Followback (TLFB)

    Heavy drinking days are defined as ≥5 drinks/day for men and ≥4 drinks/day for women within a 2-hour period. Self-reported data via TLFB used to calculate the percentage of heavy drinking days during the 3-month follow-up treatment.

    Measured: 3 months post-treatment

Secondary outcomes (5)
  1. Change in Salience Network Functional Connectivity During FACES Task, Measured via fMRI

    Functional connectivity between the dACC and prefrontal cortex (PFC) will be assessed using fMRI during the FACES Task. Connectivity strength will be calculated using psychophysiological interaction (PPI) analysis or similar methods.

    Measured: 1-4 days post treatment

  2. Change in Resting-State Salience Network Activation, Measured via fMRI

    Resting-state fMRI will assess dACC activation. Measures will include percent signal change pre- to post-treatment.

    Measured: 1-4 days post-treatment

  3. Change in Resting-State Salience Network Functional Connectivity, Measured via fMRI

    Resting-state functional connectivity between the dACC and prefrontal cortex (PFC) will be measured using CONN.

    Measured: 1-4 days post treatment

  4. Relapse Status, assessed by Timeline Followback (TLFB)

    Relapse will be defined as any alcohol use following the post-treatment period, assessed using TLFB. Outcome will be reported as a binary (yes/no) variable.

    Measured: 3 months post-treatment

  5. Total Number of Alcoholic Drinks Consumed, Assessed by Timeline Followback (TLFB)

    Self-reported alcohol use over the 3-month follow-up period will be assessed via TLFB, and the total number of standard alcoholic drinks consumed will be calculated and reported.

    Measured: 3 months post-treatment

Timeline

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

  1. First posted29 Apr 2025
  2. Study start17 Dec 2025
  3. Primary completion30 Jun 2030 (estimated)
  4. Study completion30 Jun 2030 (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 N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
2-arm, 1:1 ratio, randomized, double-blind, sham-controlled
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06949423
Sponsor's protocol ID
78836
Other IDs
R01AA031552, 1R01AA031552-01A1
Acronym
NEST-A
Status last verified
Feb 2026
First submitted
7 Apr 2025
Last updated
15 May 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
Yes: Any data, specimens, forms, reports, and other records that leave the site will be identified only by a participant ID number to maintain confidentiality. The ID Number will have no relationship to any aspect of identifiable private information. Therefore, the data associated with each participant will be completely de-identified and there will be no mechanism by which users can re-identify participant data (e.g., name, address) with the subject code.

Publications

  • Padula CB, Tenekedjieva LT, McCalley DM, Al-Dasouqi H, Hanlon CA, Williams LM, Kozel FA, Knutson B, Durazzo TC, Yesavage JA, Madore MR. Targeting the Salience Network: A Mini-Review on a Novel Neuromodulation Approach for Treating Alcohol Use Disorder. Front Psychiatry. 2022 May 17;13:893833. doi: 10.3389/fpsyt.2022.893833. eCollection 2022.

    PubMed 35656355
  • Padula CB, Tenekedjieva LT, McCalley DM, Morales JM, Madore MR. Accelerated deep TMS in alcohol use disorder: A preliminary pilot trial targeting the dorsal anterior cingulate cortex increases neural target engagement and abstinence. Brain Stimul. 2024 Sep-Oct;17(5):1098-1100. doi: 10.1016/j.brs.2024.09.002. Epub 2024 Sep 13. No abstract available.

    PubMed 39265786
  • Harel M, Perini I, Kampe R, Alyagon U, Shalev H, Besser I, Sommer WH, Heilig M, Zangen A. Repetitive Transcranial Magnetic Stimulation in Alcohol Dependence: A Randomized, Double-Blind, Sham-Controlled Proof-of-Concept Trial Targeting the Medial Prefrontal and Anterior Cingulate Cortices. Biol Psychiatry. 2022 Jun 15;91(12):1061-1069. doi: 10.1016/j.biopsych.2021.11.020. Epub 2021 Dec 6.

    PubMed 35067356
  • Peters SK, Dunlop K, Downar J. Cortico-Striatal-Thalamic Loop Circuits of the Salience Network: A Central Pathway in Psychiatric Disease and Treatment. Front Syst Neurosci. 2016 Dec 27;10:104. doi: 10.3389/fnsys.2016.00104. eCollection 2016.

    PubMed 28082874
  • Koob GF, Volkow ND. Neurocircuitry of addiction. Neuropsychopharmacology. 2010 Jan;35(1):217-38. doi: 10.1038/npp.2009.110.

    PubMed 19710631

Questions about this trial

What is this clinical trial studying?

A study testing Deep Transcranial Magnetic Stimulation (dTMS) H7 coil - Active in people with Alcohol Use Disorder (AUD) and Transcranial Magnetic Stimilation, run by Stanford University 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 7 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 15 May 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

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?

Contact Samantha J Ward, BS (650-493-5000 ext. 64975, samward@stanford.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Dorsal Anterior Cingulate Cortex Function (dACC) Activation During the FACES Task, Measured via fMRI (time frame: 1-4 days post treatment). The study lists 3 primary outcomes in all. 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 NCT06949423, which also lists 5 linked publications.

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 15 May 2026; AzTrials last refreshed its copy on 8 Nov 2026.

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