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

NCT06770556 | Recruiting FDA Device

• 1 other identifier: IRB00123420
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Alcohol Use Disorder; Alcohol Dependence; Alcohol Consumption

Keywords

Transcranial Magnetic Stimulation (TMS); Magnetoencephalography (MEG); Alcohol Use Disorder

Outcome Measures

Primary Outcomes (1)

• Number of Adverse Events Potentially Related to TMS

  The number of potential adverse events queried after each TMS session.

  Through study completion 1 year

Study Arms (4)

Four Day - Option 1

OTHER

Participants will receive active iTBS, sham iTBS, 10 Hz, 1 Hz.

Device: Sham iTBS; Device: Active iTBS; Device: 10 Hz TMS; Device: 1 Hz TMS

Two Day - Option 1

OTHER

Participants will receive active iTBS then sham iTBS.

Device: Sham iTBS; Device: Active iTBS

Four Day - Option 2

OTHER

Participants will receive sham iTBS, active iTBS, 1 Hz, 10 Hz.

Device: Sham iTBS; Device: Active iTBS; Device: 10 Hz TMS; Device: 1 Hz TMS

Two Day - Option 2

OTHER

Participants will receive sham iTBS then active iTBS.

Device: Sham iTBS; Device: Active iTBS

Interventions

Sham iTBS DEVICE

Participants will receive sham iTBS

Four Day - Option 1; Four Day - Option 2; Two Day - Option 1; Two Day - Option 2

Active iTBS DEVICE

Participants will receive active iTBS

Four Day - Option 1; Four Day - Option 2; Two Day - Option 1; Two Day - Option 2

10 Hz TMS DEVICE

Participant will receive 10 Hz TMS

Four Day - Option 1; Four Day - Option 2

1 Hz TMS DEVICE

Participant will receive 1 Hz TMS

Four Day - Option 1; Four Day - Option 2

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

RECRUITING

MeSH Terms

Conditions

Alcoholism; Alcohol Drinking

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Drinking Behavior; Behavior

Study Officials

• Merideth A Addicott, PhD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Merideth A Addicott, PhD

CONTACT

336-716-7792; Maddicot@wakehealth.edu

Michiyah Kimber

CONTACT

3367165719; michcoll@wakehealth.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2025
• First Posted: January 13, 2025
• Study Start: March 21, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)