Transcranial Magnetic Stimulation (TMS) Effects Using Magnetoencephalography (MEG) Study (TMS)

August 14, 2026 updated by: Wake Forest University Health Sciences

An Investigation of TMS Effects Using Magnetoencephalography (MEG) Among Individuals With and Without Heavy Alcohol Use

Alcohol use disorder (AUD) is a complex chronic brain disease characterized by compulsive alcohol use, loss of control over drinking, and negative emotional states. Extensive research has identified the general neural circuitry underlying AUD. There is an exciting opportunity to intervene in AUD using neuromodulation. Transcranial magnetic stimulation (TMS) offers a non-invasive method to modulate brain activity, making it a promising tool for investigating, modulating, and potentially treating AUD. However, the precise effects of TMS on neural circuits involved in AUD and the mechanisms underlying these effects must first be understood. Magnetoencephalography (MEG) is a neuroimaging method that provides direct measurement of brain activity within neural circuits with high temporal resolution. Critically, MEG can measure brain activity in a wide range of frequencies that are consistent with those targeted by TMS. The goal of this proposal is therefore to collect preliminary and feasibility data to support a future NIH grant application that would use MEG to investigate TMS effects in individuals with AUD (iAUD).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This proposal uses a mixed, between-group, within-subject design. The study will investigate the acute effects of different TMS pulse sequences in participants without AUD (non-AUD), and compare active/sham iTBS across non-AUD and AUD. On each study day, participants will complete a pre-TMS baseline MEG scan (10 min resting state), followed by a TMS pulse sequence, then complete 3 more MEG scans (immediately post-TMS, 1 hour post-TMS, and 2 hours post-TMS). Each TMS pulse sequence will be administered on a separate day and will be matched by the number of pulses administered (1200 pulses) and the total duration of administration time (20 min). The sham condition will control for auditory and sensory side effects associated with TMS. TMS will be applied to the left DLPFC, identified by the EEG F3 coordinate. Participants will either complete 4 study visits (n = 5) and receive 1 Hz, 10 Hz, iTBS, and sham, each on a separate day; or participants will complete 2 study visits (n = 5) and receive iTBS and sham, each on a separate day. Participants will also receive a structural MRI scan in order to map the MEG outcome data onto their own anatomical brain image.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
5

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest University Health Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria non-AUD Participants:

  • Diagnostic and Statistical Manual of Mental Disorders (DSM-5) score for AUD = 0
  • Alcohol Use Disorders Identification Test (AUDIT) score ≤ 7
  • Is not a heavy alcohol consumer

Inclusion Criteria AUD Participants:

  • DSM-5 score for AUD ≥ 3
  • AUDIT score ≥ 8
  • Is a heavy alcohol consumer

Exclusion Criteria:

  • Current substance use disorder other than alcohol use disorder and/or frequent use of non-prescribed psychoactive substances.
  • Current serious psychiatric disorder, and/or any history of a psychotic disorder
  • Any health problem that would interfere with the study or could be aggravated by study procedures (e.g., history of migraines, claustrophobia).
  • Is currently taking or initiates a medication known to affect alcohol intake and/or craving.
  • History of traumatic brain injury resulting in hospitalization, loss of consciousness, and/or having ever been informed he/she has an epidural, subdural, or subarachnoid hemorrhage.
  • Does not meet safety criteria for TMS or MRI.
  • Females of childbearing potential who are pregnant (by urine HCG), planning to become pregnant, nursing, or who are not using a reliable form of birth control.
  • Is at an elevated risk of seizure (i.e. has a history of seizures, is currently prescribed medications known to lower seizure threshold and has had a change in their medication).
  • Clinical Intake Withdrawal Assessment (CIWA>5) (to prevent delivering TMS to individuals in withdrawal).
  • Not able to read and understand questionnaires, assessments, and/or the informed consent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: Four Day - Option 1
Participants will receive active iTBS, sham iTBS, 10 Hz, 1 Hz.
Device: Sham iTBS
Participants will receive sham iTBS
Device: Active iTBS
Participants will receive active iTBS
Device: 10 Hz TMS
Participant will receive 10 Hz TMS
Device: 1 Hz TMS
Participant will receive 1 Hz TMS
Other: Two Day - Option 1
Participants will receive active iTBS then sham iTBS.
Device: Sham iTBS
Participants will receive sham iTBS
Device: Active iTBS
Participants will receive active iTBS
Other: Four Day - Option 2
Participants will receive sham iTBS, active iTBS, 1 Hz, 10 Hz.
Device: Sham iTBS
Participants will receive sham iTBS
Device: Active iTBS
Participants will receive active iTBS
Device: 10 Hz TMS
Participant will receive 10 Hz TMS
Device: 1 Hz TMS
Participant will receive 1 Hz TMS
Other: Two Day - Option 2
Participants will receive sham iTBS then active iTBS.
Device: Sham iTBS
Participants will receive sham iTBS
Device: Active iTBS
Participants will receive active iTBS

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Adverse Events Potentially Related to TMS
Time Frame: Through study completion 1 year
The number of potential adverse events queried after each TMS session.
Through study completion 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Wake Forest University Health Sciences

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Merideth A Addicott, PhD, Wake Forest University Health Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 21, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 29, 2026

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 29, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 7, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 7, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 13, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 17, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 14, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB00123420

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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