Developing Functional Connectivity-Guided TMS for Alcohol Use Disorder
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age25-75
SponsorVA Palo Alto Health Care System
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Active Transcranial Magnetic Simulation
Device1 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.
Sham
Device1 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.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Active fMRI-guided TMSExperimental treatment 1 intervention
Group B: Sham fMRI-guided TMSSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in blood-oxygen level dependent signal as a measure of change in alcohol cue reactivity
The effect of real versus sham fMRI-guided TMS on alcohol cue reactivity will be assessed by comparing brain reactivity to images of alcohol ('alcohol cues') shown during the fMRI scan. Change in blood-oxygen level dependent signal magnitude will be measured within the striatum, a key brain region involved in cue-reactivity.
Time frame
Baseline (pre-TMS) and Day 2 (post-TMS)Sponsors and contacts
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VA Palo Alto Health Care System
Lead sponsor
Stanford University
Collaborator
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Collaborator
Source ClinicalTrials.gov