Alcohol Use DisorderTMSNCT06770556
Transcranial Magnetic Stimulation (TMS) Effects Using Magnetoencephalography (MEG) Study
A study testing Active iTBS, 10 Hz TMS and 1 Hz TMS in people with Alcohol Use Disorder and Alcohol Dependence, run by Wake Forest University Health Sciences at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Alcohol Use Disorder, Alcohol Dependence, Alcohol Consumption
- What is being tested?
- Active iTBS, 10 Hz TMS and 1 Hz TMS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Mar 2025to 29 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
About this study
Official title: 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).
Read the 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.
- Being tested
- Sham iTBS, Active iTBS, 10 Hz TMS, 1 Hz TMS
- Keywords
- Transcranial Magnetic Stimulation (TMS), Magnetoencephalography (MEG), Alcohol Use Disorder
- Medical subject headings
- Alcoholism, Alcohol Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sham iTBSDevice
Participants will receive sham iTBS
Active iTBSDevice
Participants will receive active iTBS
10 Hz TMSDevice
Participant will receive 10 Hz TMS
1 Hz TMSDevice
Participant will receive 1 Hz TMS
| Study group | Role | What they receive |
|---|---|---|
| Four Day - Option 1 | Other | Participants will receive active iTBS, sham iTBS, 10 Hz, 1 Hz. Receives: 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. Receives: Device: Sham iTBS; Device: Active iTBS |
| Four Day - Option 2 | Other | Participants will receive sham iTBS, active iTBS, 1 Hz, 10 Hz. Receives: 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. Receives: Device: Sham iTBS; Device: Active iTBS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Adverse Events Potentially Related to TMS
The number of potential adverse events queried after each TMS session.
Measured: Through study completion 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2025
- Study start21 Mar 2025
- Primary completion29 Jul 2026
- Study completion29 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol Use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Merideth A Addicott, PhD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06770556
- Sponsor's protocol ID
- IRB00123420
- Acronym
- TMS
- Status last verified
- Feb 2026
- First submitted
- 7 Jan 2025
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Investigation of TMS Effects Using Magnetoencephalography (MEG) Among Individuals With and Without Heavy Alcohol Use
- ClinicalTrials.gov ID
- NCT06770556
- Acronym / sponsor ID
- TMS / IRB00123420
- Keywords
- Transcranial Magnetic Stimulation (TMS), Magnetoencephalography (MEG), Alcohol Use Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- 21 Mar 2025 (actual)
- Primary completion
- 29 Jul 2026 (actual)
- Study completion
- 29 Jul 2026 (actual)
- First posted
- 13 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, care provider)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Four Day - Option 1 | Other | Device: Sham iTBS, Device: Active iTBS, Device: 10 Hz TMS, Device: 1 Hz TMSParticipants will receive active iTBS, sham iTBS, 10 Hz, 1 Hz. |
| Two Day - Option 1 | Other | Device: Sham iTBS, Device: Active iTBSParticipants will receive active iTBS then sham iTBS. |
| Four Day - Option 2 | Other | Device: Sham iTBS, Device: Active iTBS, Device: 10 Hz TMS, Device: 1 Hz TMSParticipants will receive sham iTBS, active iTBS, 1 Hz, 10 Hz. |
| Two Day - Option 2 | Other | Device: Sham iTBS, Device: Active iTBSParticipants will receive sham iTBS then active iTBS. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sham iTBSParticipants will receive sham iTBS | Device | Four Day - Option 1, Four Day - Option 2, Two Day - Option 1, Two Day - Option 2 |
| Active iTBSParticipants will receive active iTBS | Device | Four Day - Option 1, Four Day - Option 2, Two Day - Option 1, Two Day - Option 2 |
| 10 Hz TMSParticipant will receive 10 Hz TMS | Device | Four Day - Option 1, Four Day - Option 2 |
| 1 Hz TMSParticipant will receive 1 Hz TMS | Device | Four Day - Option 1, Four Day - Option 2 |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Alcohol Use Disorder
Recruiting
Tdcs And cogNitive traininG cOmbined for AUD (TANGO)
Alcohol Use Disorder, Addiction
Not yet recruitingPhase 1/2
Intravenous Acetate as an Adjunctive Treatment for Alcohol Withdrawal in Hospitalized Patients
Alcohol Withdrawal, Alcohol Abstinence
Not yet recruiting
PNF RCT to Decrease Alcohol Use and Increase HIV Prevention
HIV (Human Immunodeficiency Virus), Alcohol Misuse
RecruitingObservational study
SMART-r: Substance Monitoring and Active Relapse Tracking Repository
Alcoholism, Substance-Related Disorders
RecruitingPhase 2
Phase 2 Study of Apremilast in Women and Men With Alcohol Use Disorder
Alcohol Use Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Merideth A Addicott, PhD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active iTBS, 10 Hz TMS and 1 Hz TMS in people with Alcohol Use Disorder and Alcohol Dependence, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Adverse Events Potentially Related to TMS (time frame: Through study completion 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.