RECRUITINGINTERVENTIONAL

Developing Functional Connectivity-Guided TMS for Alcohol Use Disorder

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 willing to sign a consent form 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. Who Should NOT Join This Trial: - 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. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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.

Treatments Being Tested

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.

Locations (1)

VA Palo Alto Health Care System

Palo Alto, California, United States