Assessing the Impact of Deep TMS Neuromodulation on Neural Circuits Associated With Alcohol Use Disorder
Launched by STANFORD UNIVERSITY · Apr 21, 2025
Trial Information
Current as of July 04, 2025
Not yet recruiting
Keywords
ClinConnect Summary
This clinical trial is looking at a treatment called deep transcranial magnetic stimulation (TMS) to help Veterans with Alcohol Use Disorder (AUD). The goal is to see if this method can reduce the chances of relapse, which is when someone goes back to drinking after trying to quit. The study is not yet recruiting participants, but it will involve adults aged 18 to 75 who have been diagnosed with moderate to severe AUD.
To participate, individuals must be able to attend scheduled visits, understand and sign consent forms, and be stable in their overall health and medication use. However, there are some important criteria that could exclude someone from the study, such as having certain medical devices (like a pacemaker) or active health issues that might interfere with the trial. Participants will receive treatment at a clinic and be monitored throughout the study to ensure their safety and well-being. This trial aims to explore a new treatment option for those struggling with alcohol dependency.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • 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.
- 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
- • Acute or unstable chronic illness.
- • Current or lifetime history of bipolar disorder or psychosis
About Stanford University
Stanford University is a prestigious academic institution renowned for its cutting-edge research and innovation in healthcare and medicine. As a clinical trial sponsor, Stanford leverages its extensive resources, including a collaborative network of world-class researchers and state-of-the-art facilities, to advance medical knowledge and improve patient care. The university is committed to conducting rigorous, ethical research that adheres to the highest standards of scientific integrity, fostering an environment where groundbreaking discoveries can translate into effective clinical applications. Through its clinical trials, Stanford aims to address critical health challenges and contribute to the development of novel therapies and treatment strategies.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Palo Alto, California, United States
Patients applied
Trial Officials
Claudia B Padula, PhD
Principal Investigator
Stanford University
Michelle R Madore, PhD
Principal Investigator
Stanford University
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported