Examining the Effectiveness of Deep TMS in Veterans With Alcohol Use Disorder

Not Applicable

Active, not recruiting

• Conditions: Alcohol Use Disorder (AUD); Transcranial Magnetic Stimulation
• Interventions: Device: Deep Transcranial Magnetic Stimulation (dTMS) H7 coil

• Registration Number: NCT04927364
• Lead Sponsor: Stanford University

Brief Summary

This study aims to evaluate the efficacy of deep transcranial magnetic stimulation (dTMS) as a treatment for Veterans with an alcohol use disorder (AUD).

Detailed Description

At least 60% of those with AUD will experience a major relapse period within 6 months of treatment, irrespective of the intervention (psychosocial and/or pharmacological) employed. Consequently, the high prevalence of AUD and relapse following treatment in Veterans is associated with substantial resource allocation and costs for the VA Health Care System. Current pharmacological and psychosocial interventions demonstrate only a moderate level of efficacy, which is reflected in the high rate of relapse in AUD.

TMS is a neurostimulation method that is at the forefront of innovative, non-invasive, and safe treatments for AUD, and other psychiatric disorders. To reduce the high rate of relapse in Veterans with AUD, it is necessary for interventions to more effectively address the associated neurobiological dysfunction. Non-invasive neuromodulation techniques are showing promise toward the aim of modifying specific and selective neural targets related to AUD and relapse. However, device-based interventions to date for AUD have focused on cortical stimulation. In contrast, preclinical and clinical studies, including our research team's preliminary data, suggest that subcortical nodes within the salience network could be promising novel neuromodulation targets. The dorsal anterior cingulate cortex (dACC) is a core node of the salience network, and hence the target of this proposal. Deep repetitive transcranial magnetic stimulation (dTMS) is one type of neuromodulation technique, and utilizing an H7 coil design can reach the dACC. Monitoring periodically throughout the first 6 months following treatment is crucial, given relapse within the first 6 months of treatment is robustly related to poor psychosocial functioning over the ensuing 1-3 years. The ultimate goal of this proposal is to provide treatment that more effectively promotes sustained abstinence in the Veteran with AUD, as extended abstinence is robustly associated with optimum biomedical, neuropsychological, psychiatric, and psychosocial recovery and functioning.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2021-06-01
• Study First Submitted QC: 2021-06-08
• Study First Posted: 2021-06-16
• Study Start: 2022-09-06
• Primary Completion: 2023-05-17
• Results First Submitted: 2024-05-15
• Results First Submitted QC: 2024-07-05
• Results First Posted: 2024-07-10
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-26
• Last Update Posted: 2024-12-16
• Study Completion: 2025-07-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 8

Inclusion Criteria

• The study will be open to male and females, regardless of race and ethnic origin, 21-70 years of age, who are in active treatment for an AUD at the VAPAHCS, Foundations of Recovery.
• Participants must meet Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria for AUD, and alcohol is self-identified as the primary substance of misuse.
• Able to read, verbalize understanding, and voluntarily sign the Informed Consent Form prior to participation in study procedures in English.
• Participants will be accepted if taking medications specifically for the treatment of major depressive disorders, cigarette smoking, or for other psychiatric conditions as long as the medications are not documented to lower seizure threshold - it would be clinically contraindicated to require participants to discontinue such medications for research. rTMS is safely administered to individuals who are taking psychotropic medications that do not lower seizure threshold.
• Participants will be abstinent from alcohol and non-prescribed substances for at least 7 consecutive days prior to rTMS to ensure no participant is experiencing active acute withdrawal.

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Exclusion Criteria

Psychiatric:

• Current diagnosis of Schizophrenia Spectrum Disorders and Bipolar Disorders;
• Current moderate-severe substance use disorder other than alcohol, tobacco, or marijuana, based on DSM-5 diagnostic criteria;
• Active current suicidal intent or plan (patients with a previous clinical flag for risk for suicide will be required to have an established safety plan involving their primary psychiatrist and the treatment team before entering the clinical trial, any form of previous rTMS or electroconvulsive treatment)

Biomedical:

Including, but not limited to:

• Uncontrolled thyroid disease,
• Unstable congestive heart failure,
• Angina
• Other severe cardiac illness as defined by treatment regimen changes in the prior 3 months
• Cerebrovascular accident, cancer if < 1 year since end of treatment;
• Unstable diabetes
• COPD requiring oxygen supplementation
• Alzheimer's disease
• Parkinson's disease
• Any biomedical implants with ferromagnetic content, neurostimulation devices, cardiac pacemakers or any magnetic resonance contraindications;
• Traumatic brain injury with self-reported or observed loss of consciousness > 30 minutes, any primary or traumatically induced seizure disorder, and alcohol-related seizure(s) in the past 30 days.

General:

• Lack of fluency in English;
• Wechsler Adult Reading Test below the 7th percentile (i.e., moderate or greater impairment in estimated general intelligence);
• Females who are pregnant or actively attempting pregnancy;
• Conservative exclusion for magnetic resonance research, current use of any medication or substance that is documented to lower seizure threshold or has been identified as a contraindication for rTMS treatment.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Active dTMS	Deep Transcranial Magnetic Stimulation (dTMS) H7 coil	Participants will receive 30 dTMS treatments, administered 3 times per day over 10 consecutive business days, Each treatment visit will last approximately 30 minutes in total.

Primary Outcome Measures

Name	Time	Method
Percentage of Days of Heavy Drinking	6 months	Heavy drinking is defined as consuming (in a 24 hour period) 3 or more drinks for women, or 4 or more drinks for men.
Percentage of Days Abstinent	6 months	Abstinence defined as no drinks consumed.
Number of Participants With Relapse to Alcohol 6 Months After Treatment	6 months	Six months after completing the intervention, participants will be contacted to determine self-reported relapse status. To determine relapse status, participants complete brief standardized measures of alcohol and substance use, Alcohol Timeline Followback (TLFB) and the Brief Addiction Monitor (BAM) questionnaire.

Trial Locations

Locations (1)

VA Palo Alto Health Care System; 🇺🇸 Palo Alto, California, United States