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

April 15, 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

Recruiting

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Estimated)

10

Phase

  • 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 Backup

Study Locations

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

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

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
Intervention / Treatment
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

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

Wake Forest University Health Sciences

Investigators

  • 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)

March 21, 2025

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

January 7, 2025

First Submitted That Met QC Criteria

January 7, 2025

First Posted (Actual)

January 13, 2025

Study Record Updates

Last Update Posted (Actual)

April 17, 2026

Last Update Submitted That Met QC Criteria

April 15, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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