NCT06949423

Assessing the Impact of Deep TMS Neuromodulation on Neural Circuits Associated With Alcohol Use Disorder

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Stanford University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Alcohol Use Disorder (AUD)
• Transcranial Magnetic Stimilation

Interventions

Type	Name	Description
DEVICE	Deep Transcranial Magnetic Stimulation (dTMS) H7 coil - Active	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.
DEVICE	Deep Transcranial Magnetic Stimulation (dTMS) H7 coil - Sham	The study will utilize an identical protocol using the H7 coil to administer a sham condition.

Timeline

• Start date: 2025-07-01
• Primary completion: 2029-09-01
• Completion: 2029-09-01
• First posted: 2025-04-29
• Last updated: 2025-04-29

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study