10 Participants Needed

Transcranial Magnetic Stimulation for Alcoholism

(TMS Trial)

MA
MK
Overseen ByMichiyah Kimber
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the use of transcranial magnetic stimulation (TMS), a non-invasive technique that affects brain activity, to help treat alcohol use disorder (AUD). Researchers aim to understand how TMS impacts brain circuits involved in AUD, hoping to find new management strategies for this condition. Participants will receive different combinations of TMS, including some sessions with inactive (sham) treatment for comparison. The trial seeks individuals who either consume a lot of alcohol or do not drink heavily at all. As an unphased trial, it offers participants the opportunity to contribute to groundbreaking research that could lead to innovative treatments for AUD.

Will I have to stop taking my current medications?

The trial requires that participants do not take medications known to affect alcohol intake or craving, and those that lower the seizure threshold. If you are on such medications, you may need to stop taking them to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Transcranial Magnetic Stimulation (TMS) is generally safe and well-tolerated for individuals with substance use disorders, including alcohol use disorder. Most experience only mild side effects, with headaches being the most common, which typically resolve on their own. Although there is a small risk of seizures, this remains rare. Studies indicate that the side effects of TMS in people with substance use issues resemble those in other groups, suggesting the treatment is manageable for most participants.12345

Why are researchers excited about this trial?

Researchers are excited about using Transcranial Magnetic Stimulation (TMS) for treating alcoholism because it offers a unique, non-invasive approach by directly stimulating specific regions of the brain. Unlike traditional treatments for alcoholism, which often involve medications like disulfiram or naltrexone that work by modifying the brain's chemical signals or reducing cravings, TMS targets the brain's neural activity through magnetic fields. This method could potentially provide quicker results with fewer side effects, making it a promising alternative for individuals who haven't responded well to standard treatments. Additionally, the trial explores different protocols, including variations in frequency and sequence of stimulation, which could help tailor the therapy to individual needs and optimize its effectiveness.

What evidence suggests that Transcranial Magnetic Stimulation could be an effective treatment for alcoholism?

Research has shown that transcranial magnetic stimulation (TMS), which participants in this trial may receive, can help reduce cravings and alcohol use in people with alcohol use disorder (AUD). Studies have found that TMS may lower the number of days people drink heavily. It uses magnetic fields to alter brain activity, affecting cravings and impulsive behavior. Some research also suggests that TMS can improve brain structure and function related to AUD. Overall, TMS is considered a promising tool for reducing alcohol consumption and cravings.26789

Who Is on the Research Team?

MA

Merideth A Addicott, PhD

Principal Investigator

Wake Forest University Health Sciences

Are You a Good Fit for This Trial?

This trial is for individuals with Alcohol Use Disorder (AUD). To join, participants must have a certain score on the DSM-5 and AUDIT indicating they either consume little to no alcohol or are heavy alcohol consumers. Those who don't meet these specific criteria cannot participate.

Inclusion Criteria

* Diagnostic and Statistical Manual of Mental Disorders (DSM-5) score for AUD = 0
* Alcohol Use Disorders Identification Test (AUDIT) score ≤ 7
* Is not a heavy alcohol consumer
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive TMS pulse sequences and undergo MEG scans to measure brain activity

4 days
4 visits (in-person) for Four Day option; 2 visits (in-person) for Two Day option

Follow-up

Participants are monitored for adverse events potentially related to TMS

1 year

What Are the Treatments Tested in This Trial?

Interventions

  • Transcranial Magnetic Stimulation (TMS)
Trial Overview The study tests how Transcranial Magnetic Stimulation (TMS) affects brain activity in people with AUD using Magnetoencephalography (MEG). Different frequencies of TMS, including 10 Hz and 1 Hz, as well as active and sham intermittent Theta Burst Stimulation (iTBS), are being compared.
How Is the Trial Designed?
4Treatment groups
Experimental Treatment
Group I: Two Day - Option 2Experimental Treatment2 Interventions
Group II: Two Day - Option 1Experimental Treatment2 Interventions
Group III: Four Day - Option 2Experimental Treatment4 Interventions
Group IV: Four Day - Option 1Experimental Treatment4 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials
1,432
Recruited
2,506,000+

Published Research Related to This Trial

High-frequency repetitive transcranial magnetic stimulation (rTMS) targeting the right dorsolateral pre-frontal cortex significantly reduced alcohol craving in 45 patients with alcohol dependence, demonstrating its potential as an effective treatment strategy.
The study showed a moderate effect size for the anticraving effects of rTMS, suggesting that it could be combined with other medications to further reduce cravings and prevent relapse.
Efficacy of repetitive transcranial magnetic stimulation in alcohol dependence: a sham-controlled study.Mishra, BR., Nizamie, SH., Das, B., et al.[2022]
Excitatory repetitive transcranial magnetic stimulation (rTMS) of the left dorsolateral pre-frontal cortex significantly reduces craving for substances in patients with dependence, with a strong effect size (Hedges' g = -0.62) based on a meta-analysis of 26 randomized controlled trials involving 748 participants.
In addition to reducing cravings, rTMS also effectively decreases substance consumption, particularly when using excitatory stimulation protocols, indicating its potential as a therapeutic intervention for substance dependence.
Effects of repetitive transcranial magnetic stimulation (rTMS) on craving and substance consumption in patients with substance dependence: a systematic review and meta-analysis.Zhang, JJQ., Fong, KNK., Ouyang, RG., et al.[2020]
In a chronic alcoholic patient with slight brain atrophy, transcranial magnetic stimulation (TMS) revealed an increased resting threshold and a dominance of D waves, indicating direct stimulation of corticospinal neurons, while I waves were unclear or absent.
The absence of clear I waves suggests impairment in the interneuronal circuitry due to brain damage from chronic alcohol abuse, highlighting how alcohol can affect motor pathways in the brain.
Direct recording of the output of the motor cortex produced by transcranial magnetic stimulation in a patient with cerebral cortex atrophy.Di Lazzaro, V., Oliviero, A., Pilato, F., et al.[2019]

Citations

rTMS Reduces Craving and Alcohol Use in Patients with ...These findings suggest that rTMS might be an effective add-on in treating patients with AUD and warrant replication in future large-scale ...
Repetitive Transcranial Magnetic Stimulation in Alcohol ...Each session delivered 100 trains of 30 pulses at 10 Hz. The primary predefined outcome was reduction in percentage of heavy drinking days, obtained using ...
Transcranial magnetic stimulation for alcohol use disorderThis study examined the effects of transcranial magnetic stimulation on brain structure and function, as well as alcohol craving and use, among individuals ...
Efficacy of repetitive transcranial magnetic stimulation (rTMS ...Several studies have observed a beneficial effect of rTMS on substance use disorders by reducing craving, impulsivity, and risk-taking behavior ...
Effectiveness of High-frequency rTMS in Reducing Alcohol ...The hypothesis to be tested is that repeated transcranial magnetic stimulation allows a reduction in alcohol consumption in patients with an alcohol use ...
Evidence for Safety and Tolerability of Transcranial Magnetic ...TMS is safe and well-tolerated for people with SUDs. The prevalence of side effects from TMS in people with SUDs is comparable to that in the ...
Transcranial Magnetic Stimulation and Deep Brain Stimulation ...However, to the best of our knowledge, no deep TMS treatment specific to alcohol dependence has been reported. Deep Brain Stimulation for the treatment of ...
Assessment and Management of Concurrent Substance ...Limited data are available to inform clinicians on how to manage concurrent substance use in the context of repetitive transcranial magnetic ...
Trans-cranial Magnetic Stimulation in Treatment of Alcohol ...TMS is a safe procedure, with a common side effect being headache and a severe (but low risk) side effect being seizure.27,28 Apart from proven safety, the ...
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