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Behavioural Intervention

TMS for Alcoholism

N/A

Recruiting

Research Sponsored by Medical University of South Carolina

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 21-65

Consumption of more than 14 drinks (women) or 21 drinks (men) per week, with at least 4 heavy drinking days per week during the 30-days prior to enrolling

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline (week 1), post-treatment (4-weeks from baseline), 1-month post treatment (follow-up #1), 2-months post treatment (follow-up #2), 3-months post treatment (follow-up #3)

Awards & highlights

Study Summary

This trial will test whether transcranial magnetic stimulation (TMS) can be used to reduce the desire to drink alcohol and the brain's response to alcohol-related pictures.

Who is the study for?

This trial is for adults aged 21-65 who drink heavily, meeting specific criteria (over 14 drinks per week for women and over 21 for men). Participants must have Alcohol Use Disorder as defined by DSM-V. Exclusions include unstable medical conditions, metal implants above the neck, pregnancy or inadequate birth control use, certain psychiatric disorders, history of severe head injury or substance abuse other than nicotine.Check my eligibility

What is being tested?

The study tests theta burst stimulation (TBS) to the medial prefrontal cortex (mPFC) using transcranial magnetic stimulation (TMS), a non-invasive brain stimulation technique. It aims to see if TBS can reduce alcohol cravings and alter responses to alcohol-related cues. Participants will receive either real TBS or a sham procedure as a control.See study design

What are the potential side effects?

Potential side effects from TMS/TBS may include discomfort at the site of stimulation, headache, lightheadedness, risk of seizure in susceptible individuals although rare with modern protocols, and temporary hearing changes due to the noise during treatment.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 21 and 65 years old.

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I drink more than the recommended weekly limit and have heavy drinking days.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline (week 1), post-treatment (4-weeks from baseline), 1-month post treatment (follow-up #1), 2-months post treatment (follow-up #2), 3-months post treatment (follow-up #3)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline (week 1), post-treatment (4-weeks from baseline), 1-month post treatment (follow-up #1), 2-months post treatment (follow-up #2), 3-months post treatment (follow-up #3)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (week 1), post-treatment (4-weeks from baseline), 1-month post treatment (follow-up #1), 2-months post treatment (follow-up #2), 3-months post treatment (follow-up #3) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Percent Days Abstinent (PDA) from baseline

Change in Percent Heavy Drinking Days (PHDD) from baseline

Change in alcohol cue task MRI activation 1-week post treatment from baseline

Secondary outcome measures

Change in alcohol use via Alcohol Audit from baseline

Alcohol Use Disorder

Change in anxiety via State-Trait Anxiety Inventory from baseline

+3 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Real TBS to the mPFCExperimental Treatment1 Intervention

For continuous theta burst stimulation (cTBS), participants will receive 3 sessions of stimulation per visit over the left medial prefrontal cortex (mPFC) (each train: 3 pulse bursts presented at 5Hz, 15 pulses/sec, 600 pulses/session, 60 sec intertrain interval; 120% RMT, MagPro; 10-15 min inter session interval) using a figure 8 coil (Coil Cool-B65 A/P).

Group II: Sham TBS to the mPFCPlacebo Group1 Intervention

The MagVenture MagPro system has an integrated, active sham which passes current through two surface electrodes placed on the scalp. The electrodes will be placed on the left frontalis muscle for all sessions. A patient identification card will randomize participants to receive either real or sham stimulation. This system maintains blinding by a gyroscope in the coil which indicates to the clinical staff whether the coil should be rotated up or down for this participant once the card is entered into the machine. One side of the coil is active, the other is sham. The integrity of the double-blind procedure will be assessed by asking the patients and study personnel rate their confidence regarding whether they thought they received real or sham (scale 1-10).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Real TBS to the mPFC

2020

N/A

~40

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Medical University of South CarolinaLead Sponsor

933 Previous Clinical Trials

7,394,549 Total Patients Enrolled

46 Trials studying Alcoholism

5,019 Patients Enrolled for Alcoholism

National Institutes of Health (NIH)NIH

2,700 Previous Clinical Trials

7,506,790 Total Patients Enrolled

29 Trials studying Alcoholism

6,915 Patients Enrolled for Alcoholism

National Institute on Alcohol Abuse and Alcoholism (NIAAA)NIH

801 Previous Clinical Trials

1,365,311 Total Patients Enrolled

423 Trials studying Alcoholism

985,622 Patients Enrolled for Alcoholism

Media Library

MPFC Theta Burst Stimulation (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT04998916 — N/A

Alcoholism Research Study Groups: Real TBS to the mPFC, Sham TBS to the mPFC

Alcoholism Clinical Trial 2023: MPFC Theta Burst Stimulation Highlights & Side Effects. Trial Name: NCT04998916 — N/A

MPFC Theta Burst Stimulation (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04998916 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the principal aims of this experiment?

"The principal goal of this experiment, evaluated across Baseline (Week 1) and Post-treatment (4 weeks from baseline), is to examine any changes in the share of Heavy Drinking Days relative to the start. Secondary objectives involve scrutinizing movements in alcohol use via Obsessive-Compulsive Drinking Scale by measuring cravings over a score range between 0 and 40 indicating greater ability to control drinking; assessing depression levels with Becks Depression Inventory-II scored out of 63, where higher scores indicate elevated depressive symptoms; as well as evaluating alcohol severity through Alcohol AUDIT which offers an appraisal ranging from 0 to 40 denoting a heightened probability for severe"

Answered by AI

Does the eligibility criteria for this research extend to those aged eighty-five and above?

"To be considered for the trial, participants must possess a chronological age of between 21 and 65 years."

Answered by AI

Who is the ideal demographic for participating in this clinical trial?

"This study is recruiting 86 individuals aged 21 to 65 who demonstrate a history of alcohol consumption. It is essential that these participants showcase more than 14 drinks per week (women) or 21 drinks per week (men), with at least 4 days in the preceding 30-day period wherein they had 4+ drinks for women and 5+ drinks for men."

Answered by AI

Are there opportunities for enrollment in this clinical examination?

"Affirmative. According to the information on clinicaltrials.gov, this trial is presently enrolling patients. It was initially posted on July 6 2021 and has been updated as of November 11 2022., aiming for 86 participants at 1 location."

Answered by AI

How many participants are included in this research project?

"Affirmative. According to the information available on clinicaltrials.gov, this research is actively seeking participants. It was first published in July 6th 2021 and updated most recently on November 11th 2022, with a need for 86 volunteers from 1 medical site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

MPFC Theta Burst Stimulation as a Treatment Tool for Alcohol Use Disorder: Effects on Drinking and Incentive Salience

Lisa McTeague, PhD 2021. "MPFC Theta Burst Stimulation as a Treatment Tool for Alcohol Use Disorder: Effects on Drinking and Incentive Salience". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04998916.

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