Influence of TMS on Attention Modulation
TAM
A Combined Neurofeedback- TMS Intervention for Alcohol Use Disorder - Aim 2
2 other identifiers
interventional
40
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Aug 2022
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 11, 2022
CompletedFirst Submitted
Initial submission to the registry
October 26, 2022
CompletedFirst Posted
Study publicly available on registry
November 10, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2025
CompletedOctober 7, 2025
October 1, 2025
3.4 years
October 26, 2022
October 2, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Change in attention switching
MRI Task- analysis of behavioral data
Baseline, immediately following TMS A, immediately following TMS B
Change in sociomoral attention switching
MRI Task- analysis of behavioral data
Baseline, immediately following TMS A, immediately following TMS B
Change in cue reactivity
MRI Task- analysis of behavioral data
Baseline, immediately following TMS A, immediately following TMS B
Secondary Outcomes (3)
Change in brain activity attention switching
Baseline, immediately following TMS A, immediately following TMS B
Change in brain activity during sociomoral attention switching
Baseline, immediately following TMS A, immediately following TMS B
Change in brain activity during cue reactivity
Baseline, immediately following TMS A, immediately following TMS B
Study Arms (2)
TMS A
EXPERIMENTALTMS administered over right frontal eye field at 10 Hz, 110% of MT, 60 x 5 sec trains, 25 sec ITI
TMS B
ACTIVE COMPARATORTMS administered over right frontal eye field at 1 Hz, 110% of MT, 7 x 225 sec trains, 30 sec ITI
Interventions
TMS will be administered in a pattern that is either excitatory or inhibitory.
Eligibility Criteria
You may qualify if:
- \. Age 18 or Older
- A. (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
- B. (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
You may not qualify if:
- MRI Contraindications
- Presence of metal in the body that would make having a 7T MRI unsafe (including facial tattoos)
- Claustrophobia, such that individual would be unable to stay in the MRI for up to 1 hr
- Hearing loss, including tinnitus, that might be made worse by MRI or TMS
- TMS Contraindications
- Has ever had a seizure, or has a family history of epilepsy
- Taking medications or substances that lower the seizure threshold\*
- Implanted devices that are in the head or rely on physiological signals
- History of neurological disease, such as stroke or brain tumor
- Head injury with loss of consciousness greater than 30 minutes
- Actively withdrawing from alcohol
- Family history of schizophrenia or presence of psychotic symptoms
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Auburn University
Auburn, Alabama, 36849, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Samantha J Fede, PhD
Principal Investigator
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
October 26, 2022
First Posted
November 10, 2022
Study Start
August 11, 2022
Primary Completion
December 31, 2025
Study Completion
December 31, 2025
Last Updated
October 7, 2025
Record last verified: 2025-10
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ICF
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.