rTMS for Alcoholism
(MAGNA Trial)
Recruiting in Palo Alto (17 mi)
Overseen byJonathan Wai
Age: 18 - 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: New York State Psychiatric Institute
Must not be taking: Sedative-hypnotics, Opiates, Anticonvulsants, others
Disqualifiers: Substance use disorder, Psychiatric illness, Seizures, others
No Placebo Group
Approved in 2 Jurisdictions
Trial Summary
What is the purpose of this trial?The goal of this study is to investigate a treatment approach for alcohol use disorder (AUD) using a novel form of brain stimulation called deep repetitive transcranial magnetic stimulation (rTMS). The investigators will be targeting frontal regions of the brain that are important for memory and decision making. These brain regions have been shown to be impaired in patients with AUD. Previous studies have mostly used rTMS to a different frontal brain region that is not as deep. These studies have shown that rTMS can reduce craving for alcohol, but there is a lack of research showing that rTMS impacts alcohol consumption.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop all current medications, but you cannot participate if you are taking certain psychotropic medications that affect brain activity or increase seizure risk. It's best to discuss your specific medications with the trial team.
What data supports the effectiveness of the treatment rTMS for alcoholism?
Research suggests that repetitive transcranial magnetic stimulation (rTMS) may help reduce alcohol cravings and intake in people with alcohol use disorder. Studies have shown that rTMS can influence brain areas related to addiction, potentially making it a promising treatment option.
12345Is rTMS safe for treating alcoholism?
Repetitive Transcranial Magnetic Stimulation (rTMS) is generally considered safe for humans, as it is a non-invasive technique used in various studies for treating addiction, including alcohol dependence. While more research is needed, current studies suggest it can be safely applied to the brain to potentially reduce cravings and alcohol intake.
12678How does rTMS treatment for alcoholism differ from other treatments?
rTMS (Repetitive Transcranial Magnetic Stimulation) is unique because it is a non-invasive treatment that uses magnetic fields to stimulate specific areas of the brain, such as the dorsolateral prefrontal cortex, which may help reduce alcohol cravings and intake. Unlike traditional medications, rTMS directly targets brain circuits involved in addiction, offering a novel approach for treating alcohol use disorder.
236910Eligibility Criteria
This trial is for adults aged 22-55 with moderate to severe alcohol use disorder who drink at least once a week. They must be medically healthy, without major illnesses or psychiatric conditions that could affect the study, not currently pregnant, and have no history of seizures or family epilepsy.Inclusion Criteria
I am healthy with no history of major illnesses like heart disease or seizures.
You have a serious problem with drinking alcohol, as defined by the DSM-5.
I drink about 2 alcoholic drinks in an hour at least once a week.
+2 more
Exclusion Criteria
You have a mental health condition, like major depression, that would make it difficult for you to take part in the study.
I do not use drugs other than alcohol or nicotine, especially no sedatives or opiates.
My family has a history of epilepsy.
+8 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
1-2 weeks
Detoxification
Participants undergo a brief detoxification period before starting rTMS treatment
1 week
Treatment
Participants receive 3 weeks of rTMS while in the research unit, including decision-making experiments and MRI scans
3 weeks
Daily sessions (inpatient)
Follow-up
Participants meet with a study physician for assessments of alcohol use and medical management sessions
6 weeks
Weekly visits (in-person)
Participant Groups
The study tests deep rTMS brain stimulation on frontal regions involved in memory and decision-making in patients with alcohol use disorder. It aims to see if this can reduce alcohol craving and consumption compared to a sham treatment.
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Active StimulationExperimental Treatment2 Interventions
Participants will be receiving active rTMS.
Group II: Sham StimulationPlacebo Group2 Interventions
Participants will be receiving sham stimulation with a smaller coil housed within the rTMS device.
rTMS is already approved in United States, European Union for the following indications:
🇺🇸 Approved in United States as rTMS for:
- Obsessive-Compulsive Disorder (OCD)
- Major Depressive Disorder
- Migraines
- Smoking cessation
🇪🇺 Approved in European Union as rTMS for:
- Obsessive-Compulsive Disorder (OCD)
- Major Depressive Disorder
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
New York State Psychiatric InstituteNew York, NY
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Who Is Running the Clinical Trial?
New York State Psychiatric InstituteLead Sponsor
National Institute on Alcohol Abuse and Alcoholism (NIAAA)Collaborator
References
Efficacy of repetitive transcranial magnetic stimulation in alcohol dependence: a sham-controlled study. [2022]To study the anticraving efficacy of high-frequency repetitive transcranial magnetic stimulation (rTMS) of the right dorsolateral pre-frontal cortex (DLPFC) in patients with alcohol dependence.
Deep Transcranial Magnetic Stimulation of the Dorsolateral Prefrontal Cortex in Alcohol Use Disorder Patients: Effects on Dopamine Transporter Availability and Alcohol Intake. [2018]Repetitive Transcranial Magnetic Stimulation (rTMS) of the dorsolateral prefrontal cortex may affect neuro-adaptations associated with alcohol use disorder (AUD), potentially influencing craving and alcohol intake. We investigated alcohol intake and dopamine transporter (DAT) availability by Single Photon Emission Computed Tomography (SPECT) in the striatum of AUD patients before and after deep rTMS. Fourteen patients underwent baseline clinical and SPECT assessment. Eleven out of fourteen patients were randomized into two groups for the REAL (n.5) or SHAM (n.6) treatment. Clinical and SPECT evaluations were then carried out after four weeks of rTMS sessions (T1). At baseline, AUD patients showed higher striatal DAT availability than healthy control subjects (HC). Patients receiving the REAL stimulation revealed a reduction in DAT availability at T1, whereas the SHAM-treated group did not. In addition, patients receiving the REAL stimulation had a decrease in alcohol intake. The results of this longitudinal pilot study may suggest a modulatory effect of deep rTMS on dopaminergic terminals and a potential clinical efficacy in reducing alcohol intake in AUD patients. Further investigations are required to confirm these preliminary data.
Repetitive transcranial magnetic stimulation: Re-wiring the alcoholic human brain. [2020]Alcohol use disorders (AUDs) are one of the leading causes of mortality and morbidity worldwide. In spite of significant advances in understanding the neural underpinnings of AUDs, therapeutic options remain limited. Recent studies have highlighted the potential of repetitive transcranial magnetic stimulation (rTMS) as an innovative, safe, and cost-effective treatment for AUDs. Here, we summarize the fundamental principles of rTMS and its putative mechanisms of action via neurocircuitries related to alcohol addiction. We will also discuss advantages and limitations of rTMS, and argue that Hebbian plasticity and connectivity changes, as well as state-dependency, play a role in shaping some of the long-term effects of rTMS. Visual imaging studies will be linked to recent clinical pilot studies describing the effect of rTMS on alcohol craving and intake, pinpointing new advances, and highlighting conceptual gaps to be filled by future controlled studies.
The Impact of Accelerated Right Prefrontal High-Frequency Repetitive Transcranial Magnetic Stimulation (rTMS) on Cue-Reactivity: An fMRI Study on Craving in Recently Detoxified Alcohol-Dependent Patients. [2018]In alcohol-dependent patients craving is a difficult-to-treat phenomenon. It has been suggested that high-frequency (HF) repetitive transcranial magnetic stimulation (rTMS) may have beneficial effects. However, exactly how this application exerts its effect on the underlying craving neurocircuit is currently unclear. In an effort to induce alcohol craving and to maximize detection of HF-rTMS effects to cue-induced alcohol craving, patients were exposed to a block and event-related alcohol cue-reactivity paradigm while being scanned with fMRI. Hence, we assessed the effect of right dorsolateral prefrontal cortex (DLPFC) stimulation on cue-induced and general alcohol craving, and the related craving neurocircuit. Twenty-six recently detoxified alcohol-dependent patients were included. First, we evaluated the impact of one sham-controlled stimulation session. Second, we examined the effect of accelerated right DLPFC HF-rTMS treatment: here patients received 15 sessions in an open label accelerated design, spread over 4 consecutive days. General craving significantly decreased after 15 active HF-rTMS sessions. However, cue-induced alcohol craving was not altered. Our brain imaging results did not show that the cue-exposure affected the underlying craving neurocircuit after both one and fifteen active HF-rTMS sessions. Yet, brain activation changes after one and 15 HF-rTMS sessions, respectively, were observed in regions associated with the extended reward system and the default mode network, but only during the presentation of the event-related paradigm. Our findings indicate that accelerated HF-rTMS applied to the right DLPFC does not manifestly affect the craving neurocircuit during an alcohol-related cue-exposure, but instead it may influence the attentional network.
Accelerated repetitive transcranial magnetic stimulation does not influence grey matter volumes in regions related to alcohol relapse: An open-label exploratory study. [2018]The application of repetitive transcranial magnetic stimulation (rTMS) to prevent relapse in alcohol addiction is currently being evaluated. However, how rTMS may influence the related brain processes is far from clear. Here we wanted to investigate whether baseline grey matter volume (GMV) can predict relapse and whether 15 accelerated high-frequency (HF)- rTMS sessions may influence GMV in areas related to relapse. Voxel-based morphometric (VBM) measurements were used to compare baseline GMV of 22 detoxified, hospitalized, alcohol-dependent patients with 22 age and gender matched healthy control subjects. Only patients received 15 accelerated HF-rTMS sessions at the right dorsolateral prefrontal cortex (DLPFC) followed by VBM measurements. Relapse rates were assessed four weeks after the end of the stimulation protocol. At baseline, alcohol-dependent patients overall showed less GMV in diffuse brain areas compared to healthy controls. Relapsers compared to abstainers displayed larger GMV decreases, especially in brain midline structures, insular, hippocampal, and amygdalar areas. Accelerated HF-rTMS treatment had no significant effect on GMV in alcohol-dependent patients, regardless of the relapse state. Although an accelerated HF-rTMS treatment protocol did not influence GMV in alcohol-dependent patients, baseline GMV predicted future relapse.
Repetitive transcranial magnetic stimulation and drug addiction. [2019]Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive brain stimulation technique that is now being tested for its ability to treat addiction. This review discusses current research approaches and results of studies which measured the therapeutic use of rTMS to treat tobacco, alcohol and illicit drug addiction. The research in this area is limited and therefore all studies evaluating the therapeutic use of rTMS in tobacco, alcohol or illicit drug addiction were retained including case studies through NCBI PubMed ( http://www.ncbi.nlm.nih.gov ) and manual searches. A total of eight studies were identified that examined the ability of rTMS to treat tobacco, alcohol and cocaine addiction. The results of this review indicate that rTMS is effective in reducing the level of cravings for smoking, alcohol, and cocaine when applied at high frequencies to the dorsolateral prefrontal cortex (DLPFC). Furthermore, these studies suggest that repeated sessions of high frequency rTMS over the DLPFC may be most effective in reducing the level of smoking and alcohol consumption. Although work in this area is limited, this review indicates that rTMS is a promising modality for treating drug addiction.
Resting state connectivity in alcohol dependent patients and the effect of repetitive transcranial magnetic stimulation. [2016]Alcohol dependence is thought to result from an overactive neural motivation system and a deficient cognitive control system, and rebalancing these systems may mitigate excessive alcohol use. This study examines the differences in functional connectivity of the fronto-parietal cognitive control network (FPn) and the motivational network (striatum and orbitofrontal cortex) between alcohol dependent patients (ADPs) and healthy controls (HCs), and the effect of repetitive transcranial magnetic stimulation (rTMS) on these networks. This randomized controlled trial included 38 ADPs and 37 HCs, matched on age, gender and education. Participants were randomly assigned to sham or right dorsolateral prefrontal cortex (dlPFC) stimulation with rTMS. A 3T resting state functional Magnetic Resonance Imaging (fMRI) scan was acquired before and after active or sham 10Hz rTMS. Group differences of within and between network connectivity and the effect of rTMS on network connectivity was assessed using independent component analysis. Results showed higher connectivity within the left FPn (p=0.012) and the left fronto-striatal motivational network (p=0.03) in ADPs versus HCs, and a further increase in connectivity within the left FPn after active stimulation in ADPs. ADPs also showed higher connectivity between the left and the right FPns (p=0.025), and this higher connectivity was related to fewer alcohol related problems (r=0.30, p=0.06). The results show higher within and between network connectivity in ADPs and a further increase in fronto-parietal connectivity after right dlPFC rTMS in ADPs, suggesting that frontal rTMS may have a beneficial influence on cognitive control and may result in lower relapse rates.
A sham-controlled trial of repetitive transcranial magnetic stimulation over left dorsolateral prefrontal cortex and its effects on craving in patients with alcohol dependence. [2022]The aim of this study is to study the effects of repetitive transcranial magnetic stimulation (rTMS) therapy over the left dorsolateral prefrontal cortex (DLPFC) in craving in drug-naive male inpatients of alcohol dependence syndrome.
rTMS Reduces Craving and Alcohol Use in Patients with Alcohol Use Disorder: Results of a Randomized, Sham-Controlled Clinical Trial. [2022](1) Background: Current evidence-based treatments for alcohol use disorder (AUD) are moderately effective. Studies testing repetitive transcranial magnetic stimulation (rTMS) in AUD commonly apply a limited number of rTMS sessions with different rTMS settings, showing inconsistent effects on craving for alcohol. This study tested the efficacy of a robust rTMS protocol on craving and alcohol use. (2) Methods: In a single-blind randomized controlled trial in recently detoxified patients with AUD, ten days of high-frequency rTMS over the right dorsolateral prefrontal cortex on top of treatment as usual (n = 14) was compared with sham rTMS (n = 16). Outcome measures were alcohol craving and use over a follow-up period of one year. Analysis was performed by means of repeated measures multivariate analysis of variance. (3) Results: The results showed a main group-by-time interaction effect on craving (Wilks' Λ = 0.348, F (12, 17) = 2.654, p = 0.032) and an effect of group on alcohol use (Wilk's Λ = 0.44, F (6, 23) = 4.9, p = 0.002), with lower alcohol craving and use in the group with active rTMS compared to the control group. Differences in craving between groups were most prominent three months after treatment. At 12 months follow-up, there was no effect of rTMS on craving or abstinence. (4) Conclusions: This small-scale randomized controlled trial showed the efficacy of high-frequency rTMS over the right dlPFC diminished alcohol craving and use in recently detoxified patients with AUD during the first months after detoxification. These findings suggest that rTMS might be an effective add-on in treating patients with AUD and warrant replication in future large-scale studies.
Comparison of anticraving efficacy of right and left repetitive transcranial magnetic stimulation in alcohol dependence: a randomized double-blind study. [2022]The objective of this study was to compare the anticraving efficacy of high-frequency repetitive transcranial magnetic stimulation (rTMS) of the right versus left dorsolateral prefrontal cortex (DLPFC) in patients with alcohol dependence. Twenty patients with alcohol dependence syndrome were randomly allocated to receive either right or left rTMS over the right DLPFC (10 sessions at 10 Hz frequency; 20 trains per session; 4.9 seconds per train and intertrain interval 30 seconds) and were assessed on the Alcohol Craving Questionnaire (ACQ-NOW) to measure craving. Two-way repeated-measures analysis of variance for ACQ-NOW total score showed no main effect of group (F[1,18] = 0.0001 but significant main effect of time (F[1,18] = 185.91, p