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NCT04998916 · ClinicalTrials.gov registry record · NA

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

A NA study of Alcohol Use Disorder and Substance Use, sponsored by Medical University of South Carolina.

Recruiting
Registry status
NA
Development phase
86
Enrollment target
1
Study location

NCT04998916: Recruiting NA study of Alcohol Use Disorder and Substance Use, sponsored by Medical University of South Carolina.

NCT04998916 is a NA study of Alcohol Use Disorder and Substance Use that is actively recruiting participants, run by Medical University of South Carolina. The registered enrollment target is 86 participants, below the 328-participant average among 184 other Alcohol Use Disorder trials with a reported enrollment target (74% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04998916, a NA study of Alcohol Use Disorder and Substance Use, is actively recruiting participants, sponsored by Medical University of South Carolina.

RECRUITING
Registry status
NA
Development phase
86 participants
Enrollment target
1
Study location

Study Summary

The purpose of this study is to develop transcranial magnetic stimulation (TMS), specifically TMS at a frequency known as theta burst stimulation (TBS), to see how it affects the brain and changes the brain's response to alcohol-related pictures. TMS and TBS are stimulation techniques that use magnetic pulses to temporarily excite specific brain areas in awake people (without the need for surgery, anesthetic, or other invasive procedures). TBS, which is a form of TMS, will be applied over the medial prefrontal cortex, (MPFC), which has been shown to be involved with drinking patterns and alcohol consumption. This study will test whether TBS can be used as an alternative tool to reduce the desire to use alcohol and reducing the brain's response to alcohol-related pictures.

Primary Outcome

The primary outcome analysis will examine the TMS treatment effect (active vs. sham) on drinking outcomes-measured as percent heavy drinking days (PHDD) (heavy drinking day defined as 4 or more drinks for women and 5 or more drinks for men)-in the follow-up period beginning after the final treatment session. Collected via timeline follow back (TLFB) in three 28-day (month) intervals, this will be analyzed using multivariate mixture models to consider the effect of time (month after treatment) an

Interventions

  • DEVICE Real TBS to the mPFC
  • DEVICE Sham TBS to the mPFC

Study Locations (1)

South Carolina

  • Medical University of South Carolina - Charleston

Trial Details

FieldValue
Enrollment Target 86 participants
Start Date 2021-07-06
Est. Completion 2026-12-31
Phase NA

What NCT04998916 shows while recruiting

NCT04998916 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 86 participants, a relatively small participant target, below the 328-participant average among 184 other Alcohol Use Disorder trials with a reported enrollment target (74% lower).

The record links to 5 conditions, with Alcohol Use Disorder appearing as the primary indexed condition, and to 2 interventions - of which Real TBS to the mPFC is the first listed.

NCT04998916 reports a single indexed study location in South Carolina.

Frequently Asked Questions

What is clinical trial NCT04998916 about?

NCT04998916 is a clinical study titled "MPFC Theta Burst Stimulation as a Treatment Tool for Alcohol Use Disorder: Effects on Drinking and Incentive Salience". The purpose of this study is to develop transcranial magnetic stimulation (TMS), specifically TMS at a frequency known as theta burst stimulation (TBS), to see how it affects the brain and changes the brain's response to alcohol-related pictures. TMS and TBS are stimulation techniques that use magne...

What is the current status of trial NCT04998916?

This trial is currently recruiting. It is a NA study. The enrollment target is 86 participants. The study started on 2021-07-06. Estimated completion is 2026-12-31.

What conditions does trial NCT04998916 study?

This clinical trial studies the following conditions: Alcohol Use Disorder, Substance Use, Alcohol Drinking, Alcohol Use Disorder (AUD), Drinking, Alcohol.

What interventions are being tested in trial NCT04998916?

The interventions under investigation include: Real TBS to the mPFC (DEVICE), Sham TBS to the mPFC (DEVICE).

Who is sponsoring clinical trial NCT04998916?

This trial is sponsored by Medical University of South Carolina, which has 755 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04998916 being conducted?

This trial has 1 study location across South Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Alcohol Use Disorder

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT04998916's enrollment target sits among peer trials

86 97th of 184 higher than 88 of 184 other Alcohol Use Disorder trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Alcohol Use Disorder trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04998916, the US trial registry maintained by the National Library of Medicine. NCT04998916 (small enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.