Deep Transcranial Magnetic Stimulation for Alcoholism

Overseen By Samantha J Ward, BS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Stanford University

Must not be taking: Benzodiazepines, Neuroleptics

Disqualifiers: Substance abuse, Seizure disorder, Bipolar, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 11

Duration: 2 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether deep transcranial magnetic stimulation (dTMS) can help veterans with Alcohol Use Disorder (AUD) avoid relapse. The treatment uses magnetic fields to target specific brain areas. Participants will receive either the real treatment or a sham (fake) version for comparison. Veterans diagnosed with moderate to severe AUD and stable enough to attend regular sessions might be suitable candidates.

As an unphased trial, this study allows veterans to contribute to innovative research that could lead to new treatment options for AUD.

Will I have to stop taking my current medications?

If you are on a stable medication regimen for other symptoms, you can continue taking them during the study. However, you must stop taking any medications that increase seizure risk at least two weeks before treatment.

What prior data suggests that deep transcranial magnetic stimulation is safe for treating alcohol use disorder?

Research has shown that deep transcranial magnetic stimulation (dTMS) holds promise as a treatment for alcohol use disorder. Studies have found that dTMS can significantly reduce alcohol cravings. Regarding safety, dTMS is generally well-tolerated, with most individuals not experiencing severe side effects. Some may encounter mild headaches or discomfort at the application site, but these effects are typically temporary.

This treatment has been used for other conditions and has a history of safety in humans. Although this specific trial is not collecting new safety data, previous studies on dTMS suggest it is a safe option for most individuals considering it for alcohol use disorder. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Deep Transcranial Magnetic Stimulation (dTMS) for alcoholism because it offers a non-invasive and innovative approach that differs from traditional options like medication and behavioral therapies. Unlike standard treatments, which often involve pharmaceuticals targeting neurotransmitter systems, dTMS directly stimulates specific brain regions associated with addiction control using magnetic fields. This method could potentially lead to faster and more effective results by directly influencing brain function, offering hope for those who haven't found success with current treatments.

What evidence suggests that deep transcranial magnetic stimulation is effective for alcohol use disorder?

Research has shown that deep transcranial magnetic stimulation (dTMS) can significantly reduce cravings for alcohol in people with Alcohol Use Disorder (AUD). One study reported a substantial decrease in craving scores, with a measure of -1.26, indicating a very significant effect. Another study found that dTMS reduced both cravings and alcohol consumption. This trial will compare active dTMS with sham dTMS to further investigate its effectiveness. These early results suggest that dTMS could be a promising method to help prevent alcohol relapse. However, more research is needed to confirm these findings on a larger scale. ^{1 2 3 5 6}

Who Is on the Research Team?

Michelle R Madore, PhD

Principal Investigator

Stanford University

Claudia B Padula, PhD

Principal Investigator

Stanford University

Are You a Good Fit for This Trial?

This trial is for veterans with Alcohol Use Disorder (AUD) who are seeking treatment to reduce their risk of relapse. Specific eligibility criteria details were not provided, so it's important to contact the study organizers for more information on who can participate.

Inclusion Criteria

My current medication for other health issues will not change during the study.

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

Exclusion Criteria

Acute or unstable chronic illness

I am taking medication that affects seizure risk.

I have a history of bipolar disorder or psychosis.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 30 sessions of active or sham dTMS to the dACC/mPFC with the H7 coil, administered 3 times per day over 10 consecutive business days

2 weeks

10 visits (in-person)

Follow-up

Participants are monitored for changes in neural connectivity and alcohol consumption post-treatment

3 months

Follow-up assessments at 1-4 days and 3 months post-treatment

What Are the Treatments Tested in This Trial?

Interventions

• Deep Transcranial Magnetic Stimulation (dTMS)

Trial Overview The study is testing the effectiveness of deep transcranial magnetic stimulation (dTMS) using an H7 coil. Participants will be randomly assigned to receive either active dTMS or a sham (placebo-like) procedure to compare outcomes.

How Is the Trial Designed?

Group I: Active dTMS Experimental Treatment 1 Intervention

Participants will receive 30 sessions of active-dTMS to the dACC/mPFC with the H7 coil, administered 3 times per day over 10 consecutive business days. Each treatment visit will last approximately 30 minutes in total.

Group II: Sham dTMS Placebo Group 1 Intervention

Participants will receive 30 sham dTMS sessions, administered 3 times per day over 10 consecutive business days. Each treatment visit will last approximately 30 minutes in total.

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of repetitive transcranial magnetic stimulation in alcohol dependence: a sham-controlled study. Mishra, BR., Nizamie, SH., Das, B., et al.[2022]

In a study involving 51 patients with alcohol use disorder, deep repetitive transcranial magnetic stimulation (dTMS) significantly reduced the percentage of heavy drinking days compared to a sham treatment, indicating its potential efficacy as a treatment for alcohol addiction.

The treatment was associated with changes in brain connectivity, particularly in areas linked to addiction, suggesting that dTMS may work by altering neural circuits involved in alcohol use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Repetitive Transcranial Magnetic Stimulation in Alcohol Dependence: A Randomized, Double-Blind, Sham-Controlled Proof-of-Concept Trial Targeting the Medial Prefrontal and Anterior Cingulate Cortices. Harel, M., Perini, I., Kämpe, R., et al.[2022]

In a pilot study involving 14 patients with alcohol use disorder (AUD), deep repetitive Transcranial Magnetic Stimulation (rTMS) of the dorsolateral prefrontal cortex led to a significant reduction in dopamine transporter (DAT) availability and alcohol intake after four weeks of treatment.

The results suggest that rTMS may modulate dopaminergic activity, indicating its potential efficacy as a therapeutic intervention for reducing alcohol consumption in AUD patients, although further research is needed to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Deep Transcranial Magnetic Stimulation of the Dorsolateral Prefrontal Cortex in Alcohol Use Disorder Patients: Effects on Dopamine Transporter Availability and Alcohol Intake. Addolorato, G., Antonelli, M., Cocciolillo, F., et al.[2018]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

Repetitive transcranial magnetic stimulation (rTMS) has shown effectiveness in reducing cravings for tobacco, alcohol, and cocaine when applied at high frequencies to the dorsolateral prefrontal cortex (DLPFC), based on a review of eight studies.

Repeated sessions of high-frequency rTMS over the DLPFC may be particularly beneficial for decreasing smoking and alcohol consumption, suggesting that rTMS could be a promising treatment option for drug addiction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Repetitive transcranial magnetic stimulation and drug addiction. Barr, MS., Farzan, F., Wing, VC., et al.[2019]

In a study involving 60 male inpatients with alcohol dependence, repetitive transcranial magnetic stimulation (rTMS) was administered over ten daily sessions, targeting the left dorsolateral prefrontal cortex (DLPFC).

The results showed no significant reduction in alcohol craving scores immediately after treatment or two weeks later, indicating that rTMS may not be effective for reducing cravings in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A sham-controlled trial of repetitive transcranial magnetic stimulation over left dorsolateral prefrontal cortex and its effects on craving in patients with alcohol dependence. Raikwar, S., Divinakumar, KJ., Prakash, J., et al.[2022]

In a study involving 30 recently detoxified patients with alcohol use disorder, high-frequency rTMS applied over the right dorsolateral prefrontal cortex significantly reduced alcohol craving and use during the first three months after treatment compared to a sham treatment.

However, the effects of rTMS on craving and alcohol use diminished by the 12-month follow-up, indicating that while rTMS may be a beneficial short-term add-on treatment for alcohol use disorder, its long-term efficacy needs further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

rTMS Reduces Craving and Alcohol Use in Patients with Alcohol Use Disorder: Results of a Randomized, Sham-Controlled Clinical Trial. Belgers, M., Van Eijndhoven, P., Markus, W., 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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8878126/

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 ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S2451902225001259

Deep Transcranial Magnetic Stimulation Efficacy in ... The results showed a significant and large effect of real dTMS in reducing craving scores (SMCC = −1.26; 95% CI, −1.67 to −0.86; p < .001). High ...

3. recoveryanswers.org recoveryanswers.org/research-post/transcranial-magnetic-stimulation-alcohol-use-disorder-effects-brain-craving-alcohol-use/

Transcranial magnetic stimulation for alcohol use disorder This study examined the effects of transcranial magnetic stimulation on brain structure and function, as well as alcohol craving and use, among individuals ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT02691390

Deep Repetitive Transcranial Magnetic Stimulation for ... A way for patients with serious diseases or conditions who cannot participate in a clinical trial to gain access to a medical product that has not been approved ...

5. biologicalpsychiatryjournal.com biologicalpsychiatryjournal.com/article/S0006-3223(21)01826-6/fulltext

Repetitive Transcranial Magnetic Stimulation in Alcohol ... Treatment included 15 sessions over 3 weeks, followed by five sessions over 3 months of follow-up. Each session delivered 100 trains of 30 ...

6. brainsway.com brainsway.com/news_events/brainsway-reports-positive-independent-pilot-data-on-accelerated-deep-tms-treatment-of-alcohol-use-disorder/

BrainsWay Reports Positive Independent Pilot Data on ... In the follow-up period after treatment, subjects receiving accelerated Deep TMS showed notably better improvements when compared to those treated by other ...