Deep TMS for Alcoholism

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Stanford University

Must not be taking: Seizure threshold-lowering drugs

Disqualifiers: Schizophrenia, Bipolar, Severe substance use, others

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

Compensation: Varies

Number of Visits: 10

Duration: 2 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the effectiveness of deep transcranial magnetic stimulation (dTMS) in treating alcohol use disorder (AUD) in Veterans. dTMS uses magnetic fields to stimulate the brain and may help reduce alcohol cravings and misuse. Participants will undergo 30 sessions of dTMS over ten business days. Veterans actively receiving treatment for AUD and who have abstained from alcohol for at least seven days may be suitable candidates for this trial. As an unphased trial, this study provides Veterans the opportunity to explore a promising treatment option for AUD.

Will I have to stop taking my current medications?

You can continue taking medications for depression, smoking, or other psychiatric conditions as long as they don't lower the seizure threshold. The trial does not require stopping these medications, but you must be abstinent from alcohol and non-prescribed substances for at least 7 days before starting the treatment.

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

Research has shown that deep transcranial magnetic stimulation (dTMS) with the H7 coil has been studied for its safety and effectiveness. The FDA has approved the H7 coil for treating obsessive-compulsive disorder (OCD), indicating a level of safety. Other studies suggest that dTMS might help treat alcohol use disorder (AUD) without causing serious side effects.

Reports indicate that dTMS is generally well-tolerated. Most treatment sessions do not lead to major problems. Some individuals might experience mild discomfort or a headache during or after the sessions, but these effects usually resolve quickly.

Overall, the evidence suggests that dTMS with the H7 coil is a promising and relatively safe option for those exploring new treatments for AUD. ^{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 approach that differs significantly from traditional treatments like medication and behavioral therapy. dTMS uses magnetic fields to stimulate specific areas of the brain associated with addiction control, potentially reducing cravings and improving self-regulation. Unlike many standard treatments that require a longer period to take effect, dTMS could provide quicker relief, as it is administered intensively over a short period. This method of targeting the brain directly is a novel approach that could complement or enhance current treatment strategies.

What evidence suggests that deep TMS is effective for alcoholism?

Research has shown that deep transcranial magnetic stimulation (dTMS) might help people with alcohol use disorder (AUD) reduce their drinking. Studies have found that dTMS can alter brain function, potentially leading to decreased alcohol consumption. One study reported positive results, suggesting that dTMS could effectively treat AUD. Additionally, dTMS has been linked to changes in brain areas related to addiction, which might help reduce alcohol cravings. This trial will investigate the effects of dTMS using the H7 coil, offering hope to those struggling with alcohol use. ^{1 4 6 7 8}

Who Is on the Research Team?

Timothy Durazzo, PhD

Principal Investigator

Stanford University

Claudia Padula, PhD

Principal Investigator

Stanford University

Michelle Madore, PhD

Principal Investigator

Stanford University

Are You a Good Fit for This Trial?

This trial is for Veterans aged 21-70 with alcohol use disorder (AUD) who are in active treatment, can consent in English, and have been sober for at least 7 days. It's not for those with severe heart or lung conditions, metal implants incompatible with magnetic fields, certain psychiatric disorders like schizophrenia or bipolar disorder, pregnant women, or anyone on medications that lower seizure threshold.

Inclusion Criteria

The study will be open to male and females, regardless of race and ethnic origin, 21-70 years of age, who are in active treatment for an AUD at the VAPAHCS, Foundations of Recovery.

Participants will be accepted if taking medications specifically for the treatment of major depressive disorders, cigarette smoking, or for other psychiatric conditions as long as the medications are not documented to lower seizure threshold - it would be clinically contraindicated to require participants to discontinue such medications for research. rTMS is safely administered to individuals who are taking psychotropic medications that do not lower seizure threshold.

Participants must meet Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria for AUD, and alcohol is self-identified as the primary substance of misuse.

Exclusion Criteria

Your thyroid disease is not well managed or under control.

You have chronic lung disease (COPD) and need to use supplemental oxygen.

Other severe cardiac illness as defined by treatment regimen changes in the prior 3 months

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 30 dTMS treatments, administered 3 times per day over 10 consecutive business days

2 weeks

10 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with a focus on relapse prevention

6 months

Periodic monitoring

What Are the Treatments Tested in This Trial?

Interventions

• Deep Transcranial Magnetic Stimulation (dTMS) H7 coil

Trial Overview The study tests deep transcranial magnetic stimulation (dTMS) using an H7 coil to treat AUD in Veterans. Participants will receive dTMS while continuing any current depression treatments as long as they don't increase the risk of seizures.

How Is the Trial Designed?

Group I: Active dTMS Experimental Treatment 1 Intervention

Participants will receive 30 dTMS treatments, 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+

VA Palo Alto Health Care System

Collaborator

Trials

97

Recruited

58,500+

Published Research Related to This Trial

In a study involving 80 detoxified patients with alcohol use disorder, 10 sessions of high-frequency repetitive transcranial magnetic stimulation (HF-rTMS) did not significantly increase the number of abstinent days over a 6-month follow-up compared to a sham treatment.

HF-rTMS also showed no impact on alcohol craving levels, indicating that this treatment may not be effective as an add-on therapy for reducing alcohol use or cravings in patients with alcohol use disorder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of 10 add-on HF-rTMS treatment sessions on alcohol use and craving among detoxified inpatients with alcohol use disorder: a randomized sham-controlled clinical trial. Hoven, M., Schluter, RS., Schellekens, AF., et al.[2023]

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 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 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]

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 26 recently detoxified alcohol-dependent patients, 15 sessions of high-frequency repetitive transcranial magnetic stimulation (HF-rTMS) significantly reduced general alcohol craving, indicating its potential efficacy as a treatment.

However, HF-rTMS did not change cue-induced alcohol craving or the underlying craving neurocircuit, suggesting that while it may help with overall craving, it does not directly affect responses to alcohol-related cues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Herremans, SC., Van Schuerbeek, P., De Raedt, R., et al.[2018]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07216872

Safety and Effectiveness of the BrainsWay Deep ... The study will compare alcohol use in two groups of subjects. One group will be assigned to the Deep TMS treatment and the other group will ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S2451865425000894

A deep TMS/fMRI trial in people with alcohol use disorder Primary neuroimaging outcomes will be changes in effective connectivity, indexed by spDCM of fMRI data, within the two cortico-striatal circuits disrupted in ...

3. reporter.nih.gov reporter.nih.gov/search/10EECF0E478CCEDF7598B8961CAA4A01A2FFCEB861BF/project-details/11134335

Project Details - NIH RePORTER The results of this study will be used to determine the efficacy of dTMS on changing brain function and drinking, whether we can identify individuals who will ...

4. investors.brainsway.com investors.brainsway.com/news-releases/news-release-details/brainsway-reports-positive-independent-pilot-data-accelerated

BrainsWay Reports Positive Independent Pilot Data on ... The outcomes were reported in a publication in the Brain Stimulation journal entitled, “Accelerated deep TMS in alcohol use disorder: A ...

5. clinicaltrial.be clinicaltrial.be/en/details/19730?per_page=100&recruiting=1&enrolling_by_invitation=1&active_not_recruiting=1&not_yet_recruiting=0&completed=0&only_recruiting=0&only_eligible=0

Examining the Effectiveness of Deep TMS in Veterans With... At least 60% of those with AUD will experience a major relapse period within 6 months of treatment, irrespective of the intervention ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S0006322321018266

Repetitive Transcranial Magnetic Stimulation in Alcohol ... An H7 deep rTMS (dTMS) coil that allows for targeting of these structures has recently been developed and has demonstrated efficacy in obsessive-compulsive ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4292849/

Transcranial Magnetic Stimulation and Deep Brain Stimulation ... Finally, successful treatment of alcohol dependence was reported with a protocol of 10 sessions of rTMS on the temporo-occipital area, but the target was ...

8. tandfonline.com tandfonline.com/doi/full/10.1080/17434440.2021.2013803

Deep TMS H7 Coil: Features, Applications & Future The H7 Coil, designed to target primarily the medial prefrontal cortex and the anterior cingulate cortex, is FDA-cleared for obsessive-compulsive disorder (OCD) ...