NCT06770556 Transcranial Magnetic Stimulation (TMS) Effects Using Magnetoencephalography (MEG) Study
| NCT ID | NCT06770556 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Wake Forest University Health Sciences |
| Condition | Alcohol Use Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 10 participants |
| Start Date | 2025-03-21 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 10 participants in total. It began in 2025-03-21 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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).
Eligibility Criteria
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.
Contact & Investigator
Merideth A Addicott, PhD
PRINCIPAL INVESTIGATOR
Wake Forest University Health Sciences
Frequently Asked Questions
Who can join the NCT06770556 clinical trial?
This trial is open to participants of all sexes, aged 21 Years or older, up to 65 Years, studying Alcohol Use Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06770556 currently recruiting?
Yes, NCT06770556 is actively recruiting participants. Contact the research team at Maddicot@wakehealth.edu for enrollment information.
Where is the NCT06770556 trial being conducted?
This trial is being conducted at Winston-Salem, United States.
Who is sponsoring the NCT06770556 clinical trial?
NCT06770556 is sponsored by Wake Forest University Health Sciences. The principal investigator is Merideth A Addicott, PhD at Wake Forest University Health Sciences. The trial plans to enroll 10 participants.