TMS for Alcohol Consumption

(TAM Trial)

Overseen By SCAMPI Lab

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Auburn University

Must not be taking: Seizure threshold-lowering drugs

Disqualifiers: MRI contraindications, TMS contraindications, Schizophrenia, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: 2 weeks

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how the brain responds to emotions and social situations and whether these responses link to alcohol consumption. Researchers use transcranial magnetic stimulation (TMS), a non-invasive brain treatment, to observe its effects on brain activity. Participants will attend three visits, including MRI scans and TMS sessions. Individuals who regularly drink alcohol or drink little to none, live in the Auburn/Opelika area, and are 19 or older are encouraged to join. As an unphased study, this trial offers participants the chance to contribute to groundbreaking research on brain activity and alcohol consumption.

Do I need to stop my current medications to join the trial?

The trial does not specify if you need to stop your current medications, but you cannot participate if you are taking medications that lower the seizure threshold (make seizures more likely).

What prior data suggests that transcranial magnetic stimulation (TMS) is safe?

Research shows that Transcranial Magnetic Stimulation (TMS) is generally safe. TMS is a non-invasive method using magnetic fields to stimulate brain cells. Studies have found it can help with conditions like depression and alcohol use disorder.

Most people experience few side effects. Occasionally, mild discomfort at the treatment site or a headache may occur, but these usually resolve quickly. Serious side effects are rare. Since TMS doesn't involve surgery or medication, it avoids many common side effects associated with those treatments.

In some studies, TMS has reduced alcohol cravings and helped with alcohol dependence. These studies support its safe use, with no major issues reported. Prospective trial participants should discuss any concerns with the study team. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Transcranial Magnetic Stimulation (TMS) for alcohol consumption because it offers a unique, non-invasive approach to treatment. Unlike traditional methods like medication or behavioral therapy, TMS targets specific brain regions using magnetic fields to potentially reduce cravings and alter addictive behaviors. The TMS A arm applies high-frequency stimulation, which might boost activity in areas linked to impulse control, while the TMS B arm uses low-frequency stimulation, possibly reducing overactivity associated with addiction. This innovative approach could provide new hope for individuals struggling with alcohol use, offering a different pathway for managing their condition.

What evidence suggests that transcranial magnetic stimulation (TMS) is effective for influencing brain engagement related to alcohol consumption?

Research has shown that transcranial magnetic stimulation (TMS) may help treat alcohol use disorder. This trial will compare two different TMS approaches: TMS A and TMS B. Studies have found that repeated TMS sessions can lower alcohol cravings and consumption. Strong evidence supports TMS for managing various conditions, including alcohol-related issues. However, results can vary, with some studies showing mixed outcomes regarding cravings and impulsivity. Overall, TMS appears to be a promising tool for those facing challenges with alcohol use. ^{1 3 6 7 8}

Who Is on the Research Team?

Samantha J Fede, PhD

Principal Investigator

Principal Investigator

Are You a Good Fit for This Trial?

This study is for adults aged 19 or older in the Auburn/Opelika area. It includes two groups: those who drink alcohol frequently (4 or more drinks at least twice a month for women, 5 or more for men) and those who rarely drink. Participants must be able to undergo MRI scans and TMS sessions without health risks.

Inclusion Criteria

I drink more than the recommended weekly limit for my gender.

I drink less than the weekly limit and rarely binge drink.

Exclusion Criteria

I have had a seizure or have a family history of epilepsy.

TMS Contraindications

MRI Contraindications

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Baseline Assessment

Participants undergo an MRI scan and answer survey questions

1 day

1 visit (in-person)

Treatment

Participants receive TMS sessions followed by MRI scans

2 weeks

2 visits (in-person)

Follow-up

Participants are monitored for changes in attention and brain activity

1-2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Transcranial Magnetic Stimulation (TMS)

Trial Overview The trial investigates how attention affects brain activity related to emotions and social understanding, especially in relation to alcohol consumption. It involves three visits over a month with MRIs and non-invasive brain stimulation called TMS.

How Is the Trial Designed?

Group I: TMS A Experimental Treatment 1 Intervention

TMS administered over right frontal eye field at 10 Hz, 110% of MT, 60 x 5 sec trains, 25 sec ITI

Group II: TMS B Active Control 1 Intervention

TMS administered over right frontal eye field at 1 Hz, 110% of MT, 7 x 225 sec trains, 30 sec ITI

Transcranial Magnetic Stimulation (TMS) is already approved in United States, European Union for the following indications:

Approved in United States as Transcranial Magnetic Stimulation (TMS) for:

• Major Depressive Disorder (MDD)
• Obsessive-Compulsive Disorder (OCD)
• Migraine Headache Symptoms

Approved in European Union as Transcranial Magnetic Stimulation (TMS) for:

• Major Depressive Disorder (MDD)
• Obsessive-Compulsive Disorder (OCD)

Who Is Running the Clinical Trial?

Auburn University

Lead Sponsor

Trials

81

Recruited

14,600+

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborator

Trials

865

Recruited

1,091,000+

Citations

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

Deep Transcranial Magnetic Stimulation Efficacy in ... Solfanelli, et al. Efficacy of add-on deep transcranial magnetic stimulation in comorbid alcohol dependence and dysthymic disorder: Three case ...

2. addicta.com.tr addicta.com.tr/Content/files/sayilar/41/388-399.pdf

Transcranial Magnetic Stimulation in Alcohol Use Disorder ... Intermittent theta burst stimulation (iTBS) has shown positive results in reducing depressive symp- ... favorable results, although the ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT03291431

Intermittent Theta Burst for the Treatment of Alcohol Use ... iTBS has demonstrated equivalent efficacy and safety to repetitive transcranial magnetic stimulation employing 10Hz stimulation protocols in treatment of ...

4. osf.io osf.io/af45t_v1/download/?format=pdf

Repetitive transcranial magnetic stimulation for alcohol use ... There is significant and growing evidence for the clinical efficacy of repetitive transcranial magnetic stimulation (rTMS) for the treatment of many ...

5. xiahepublishing.com xiahepublishing.com/2472-0712/ERHM-2022-00096

Trans-cranial Magnetic Stimulation in Treatment of Alcohol ... Overall, studies using TMS for the treatment of AUD show mixed results in changes in craving, impulsivity, and alcohol intake.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT04154111

Theta Burst Stimulation as a Tool to Decrease Drinking in ... The results of this study will be used to determine which of the 2 proposed TMS strategies has a larger effect on drinking behavior (% days abstinent, % heavy ...

7. nature.com nature.com/articles/s41386-023-01776-0

A systematic review and meta-analysis of neuromodulation ... Ninety-four studies were identified that examined the effects of rTMS, tDCS, and DBS on substance use outcomes (eg, craving, consumption, and relapse)

8. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35067356/

A Randomized, Double-Blind, Sham-Controlled Proof-of- ... We provide initial proof-of-concept for dTMS targeting midline frontocortical structures as a treatment for alcohol addiction.