Developing Functional Connectivity-Guided TMS for Alcohol Use Disorder

Launched by VA PALO ALTO HEALTH CARE SYSTEM · May 9, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new approach to help people with Alcohol Use Disorder (AUD), which includes problems like alcohol abuse and alcoholism. The researchers want to see if a single session of a treatment called transcranial magnetic stimulation (TMS), guided by brain imaging, can help reduce the brain's reaction to alcohol cues in the environment. This is important because many people relapse to drinking after trying existing treatments, and understanding how the brain responds to alcohol can help improve outcomes.

To participate, individuals need to be between the ages of 25 and 75 and have a moderate to severe diagnosis of AUD. They should be able to attend clinic visits and understand the study's information. However, certain people can't participate, including those with specific medical devices, recent history of suicidal thoughts, or certain neurological conditions. If eligible, participants can expect a supportive environment where they will receive care and possibly benefit from a new treatment aimed at helping reduce their alcohol cravings.

Gender

ALL

Eligibility criteria

• 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.