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

8 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This study aims to evaluate the efficacy of deep transcranial magnetic stimulation (dTMS) as a treatment for Veterans with an alcohol use disorder (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.

Is Deep TMS safe for humans?

Deep TMS has been studied in humans for conditions like alcohol use disorder, and while more research is needed, current studies suggest it is generally safe. No significant safety concerns have been reported in the studies, which involved multiple sessions of treatment. ^{1 2 3 4 5}

How is the Deep TMS treatment different from other treatments for alcoholism?

Deep TMS (Transcranial Magnetic Stimulation) using the H7 coil is unique because it targets deeper brain regions like the medial prefrontal cortex, which are involved in addiction pathways. This treatment modulates dopamine and cortisol levels, potentially reducing alcohol cravings and intake, unlike traditional therapies that may not directly influence these brain areas. ^{1 2 5 6 7}

What data supports the effectiveness of the treatment Deep Transcranial Magnetic Stimulation (dTMS) for alcoholism?

Research suggests that Deep Transcranial Magnetic Stimulation (dTMS) may help reduce alcohol intake and cravings in people with alcohol use disorder. Studies have shown that dTMS can affect brain areas related to addiction, potentially leading to decreased alcohol consumption and changes in brain chemicals linked to addiction. ^{1 2 5 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

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 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]

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 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. England pubmed.ncbi.nlm.nih.gov

Efficacy of repetitive transcranial magnetic stimulation in alcohol dependence: a sham-controlled study. [2022]

2. Netherlands 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. [2018]

3. United States 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. [2022]

4. Canada pubmed.ncbi.nlm.nih.gov

Deep TMS on alcoholics: effects on cortisolemia and dopamine pathway modulation. A pilot study. [2015]

5. England 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. [2023]

6. India 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. [2022]

7. United States 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. [2018]

8. England pubmed.ncbi.nlm.nih.gov

Deep TMS H7 Coil: Features, Applications & Future. [2022]