Transcranial Magnetic Stimulation (TMS) Effects Using Magnetoencephalography (MEG) Study
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21-65
SponsorWake Forest University Health Sciences
About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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.
Trial design
Design model
Crossover
Treatments tested in this trial
Sham iTBS
DeviceParticipants will receive sham iTBS
Active iTBS
DeviceParticipants will receive active iTBS
10 Hz TMS
DeviceParticipant will receive 10 Hz TMS
1 Hz TMS
DeviceParticipant will receive 1 Hz TMS
Treatment groups
10 Participants
are divided into 4 treatment groupsGroup A: Four Day - Option 1Other 4 interventions
Group B: Two Day - Option 1Other 2 interventions
Group C: Four Day - Option 2Other 4 interventions
Group D: Two Day - Option 2Other 2 interventions
Trial outcomes
Primary outcomes
1
Number of Adverse Events Potentially Related to TMS
The number of potential adverse events queried after each TMS session.
Time frame
Through study completion 1 yearSponsors and contacts
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Source ClinicalTrials.gov