Status:
NOT_YET_RECRUITING
Assessing the Impact of Deep TMS Neuromodulation on Neural Circuits Associated With Alcohol Use Disorder
Lead Sponsor:
Stanford University
Conditions:
Alcohol Use Disorder (AUD)
Transcranial Magnetic Stimilation
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief 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 rel...
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 la...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2029
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06949423
Start Date
July 1 2025
End Date
September 1 2029
Last Update
April 29 2025
Active Locations (1)
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1
VA Palo Alto Health Care System
Palo Alto, California, United States, 94304