RecruitingNot ApplicableNCT06770556

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

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


Sponsor

Wake Forest University Health Sciences

Enrollment

10 participants

Start Date

Mar 21, 2025

Study Type

INTERVENTIONAL

Conditions

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).


Eligibility

Min Age: 21 YearsMax Age: 65 Years

Inclusion Criteria6

  • 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

Exclusion Criteria10

  • 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.

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Interventions

DEVICESham iTBS

Participants will receive sham iTBS

DEVICEActive iTBS

Participants will receive active iTBS

DEVICE10 Hz TMS

Participant will receive 10 Hz TMS

DEVICE1 Hz TMS

Participant will receive 1 Hz TMS


Locations(1)

Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States

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NCT06770556


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