Influence of TMS on Attention Modulation (TAM)

October 2, 2025 updated by: Samantha Fede, Auburn University

A Combined Neurofeedback- TMS Intervention for Alcohol Use Disorder - Aim 2

The purpose of this study is to help understand how attention processes influence brain engagement during emotion and social cognition. The investigators also want to know if these processes are associated with drinking alcohol.

Participation includes three study visits of about 2 hours each over approximately a month. The first visit involves a magnetic resonance imaging (MRI) scan and answering survey questions. Each of the next two visits will involve a session of transcranial magnetic stimulation (TMS, a non-invasive brain stimulation technique) followed by another MRI scan.

People in the Auburn/Opelika area 19 or older are eligible to participate. People who drink alcohol and people who do not drink or don't drink very much are invited to participate.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Alabama
      • Auburn, Alabama, United States, 36849
        • Recruiting
        • Auburn University
        • Contact:
        • Principal Investigator:
          • Samantha J Fede, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

1. Age 18 or Older

2A. (Drinker Group): Reports consuming 4 [if female]/ 5 [if male] or more standard drinks on one occasion at least 2 times a month AND/OR reports consuming more than 7 [if female]/ 14 [if male] standard drinks per week on average

2B. (Healthy Volunteer Group): Reports consuming 4 [if female]/ 5 [if male] or more standard drinks on one occasion less than once a month AND reports consuming less than 7 [if female]/ 14 [if male] standard drinks per week on average

Exclusion Criteria:

  1. MRI Contraindications

    1. Presence of metal in the body that would make having a 7T MRI unsafe (including facial tattoos)
    2. Claustrophobia, such that individual would be unable to stay in the MRI for up to 1 hr
    3. Hearing loss, including tinnitus, that might be made worse by MRI or TMS

  2. TMS Contraindications

    1. Has ever had a seizure, or has a family history of epilepsy
    2. Taking medications or substances that lower the seizure threshold*
    3. Implanted devices that are in the head or rely on physiological signals
    4. History of neurological disease, such as stroke or brain tumor
    5. Head injury with loss of consciousness greater than 30 minutes
    6. Actively withdrawing from alcohol
  3. Family history of schizophrenia or presence of psychotic symptoms

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TMS A
TMS administered over right frontal eye field at 10 Hz, 110% of MT, 60 x 5 sec trains, 25 sec ITI
Device: TMS
TMS will be administered in a pattern that is either excitatory or inhibitory.
Other Names:
  • Magventure MagPro
Active Comparator: TMS B
TMS administered over right frontal eye field at 1 Hz, 110% of MT, 7 x 225 sec trains, 30 sec ITI
Device: TMS
TMS will be administered in a pattern that is either excitatory or inhibitory.
Other Names:
  • Magventure MagPro

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in attention switching
Time Frame: Baseline, immediately following TMS A, immediately following TMS B
MRI Task- analysis of behavioral data
Baseline, immediately following TMS A, immediately following TMS B
Change in sociomoral attention switching
Time Frame: Baseline, immediately following TMS A, immediately following TMS B
MRI Task- analysis of behavioral data
Baseline, immediately following TMS A, immediately following TMS B
Change in cue reactivity
Time Frame: Baseline, immediately following TMS A, immediately following TMS B
MRI Task- analysis of behavioral data
Baseline, immediately following TMS A, immediately following TMS B

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in brain activity attention switching
Time Frame: Baseline, immediately following TMS A, immediately following TMS B
MRI Task- analysis of imaging (fMRI) data
Baseline, immediately following TMS A, immediately following TMS B
Change in brain activity during sociomoral attention switching
Time Frame: Baseline, immediately following TMS A, immediately following TMS B
MRI Task- analysis of imaging (fMRI) data
Baseline, immediately following TMS A, immediately following TMS B
Change in brain activity during cue reactivity
Time Frame: Baseline, immediately following TMS A, immediately following TMS B
MRI Task- analysis of imaging (fMRI) data
Baseline, immediately following TMS A, immediately following TMS B

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Auburn University

Collaborators

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Investigators

  • Principal Investigator: Samantha J Fede, PhD, Principal Investigator

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 11, 2022

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

October 26, 2022

First Submitted That Met QC Criteria

November 3, 2022

First Posted (Actual)

November 10, 2022

Study Record Updates

Last Update Posted (Estimated)

October 7, 2025

Last Update Submitted That Met QC Criteria

October 2, 2025

Last Verified

October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21510
  • R00AA027830 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data will be shared through the NIAAA Data Archive according to standard NIAAA procedures. This will include deidentified behavioral, self-report, and imaging data.

Participants will have the option to opt out of having their individual data available.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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