Back to resultsInfluence of TMS on Attention Modulation (TAM)
Primary Purpose
Drinking, Alcohol
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
TMS
Sponsored by
About this trial
This is an interventional basic science trial for Drinking, Alcohol focused on measuring alcohol, attention, TMS, binge drinking, emotion, social cognition, moral, MRI, frontal eye fields, moral cognition
Eligibility Criteria
Inclusion Criteria: 1. Age 19 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: 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
Sites / Locations
- Auburn UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
TMS A
TMS B
Arm Description
TMS administered over right frontal eye field at 10 Hz, 110% of MT, 60 x 5 sec trains, 25 sec ITI
TMS administered over right frontal eye field at 1 Hz, 110% of MT, 7 x 225 sec trains, 30 sec ITI
Outcomes
Primary Outcome Measures
Change in attention switching
MRI Task- analysis of behavioral data
Change in sociomoral attention switching
MRI Task- analysis of behavioral data
Change in cue reactivity
MRI Task- analysis of behavioral data
Secondary Outcome Measures
Change in brain activity attention switching
MRI Task- analysis of imaging (fMRI) data
Change in brain activity during sociomoral attention switching
MRI Task- analysis of imaging (fMRI) data
Change in brain activity during cue reactivity
MRI Task- analysis of imaging (fMRI) data
Full Information
NCT ID
NCT05611502
First Posted
October 26, 2022
Last Updated
November 3, 2022
Sponsor
Auburn University
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
1. Study Identification
Unique Protocol Identification Number
NCT05611502
Brief Title
Influence of TMS on Attention Modulation
Acronym
TAM
Official Title
A Combined Neurofeedback- TMS Intervention for Alcohol Use Disorder - Aim 2
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 11, 2022 (Actual)
Primary Completion Date
August 10, 2023 (Anticipated)
Study Completion Date
August 10, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Auburn University
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Drinking, Alcohol
Keywords
alcohol, attention, TMS, binge drinking, emotion, social cognition, moral, MRI, frontal eye fields, moral cognition
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Participants will be randomly assigned to receive each arm in counterbalanced order (AB or BA).
Masking
Participant
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
TMS A
Arm Type
Experimental
Arm Description
TMS administered over right frontal eye field at 10 Hz, 110% of MT, 60 x 5 sec trains, 25 sec ITI
Arm Title
TMS B
Arm Type
Active Comparator
Arm Description
TMS administered over right frontal eye field at 1 Hz, 110% of MT, 7 x 225 sec trains, 30 sec ITI
Intervention Type
Device
Intervention Name(s)
TMS
Other Intervention Name(s)
Magventure MagPro
Intervention Description
TMS will be administered in a pattern that is either excitatory or inhibitory.
Primary Outcome Measure Information:
Title
Change in attention switching
Description
MRI Task- analysis of behavioral data
Time Frame
Baseline, immediately following TMS A, immediately following TMS B
Title
Change in sociomoral attention switching
Description
MRI Task- analysis of behavioral data
Time Frame
Baseline, immediately following TMS A, immediately following TMS B
Title
Change in cue reactivity
Description
MRI Task- analysis of behavioral data
Time Frame
Baseline, immediately following TMS A, immediately following TMS B
Secondary Outcome Measure Information:
Title
Change in brain activity attention switching
Description
MRI Task- analysis of imaging (fMRI) data
Time Frame
Baseline, immediately following TMS A, immediately following TMS B
Title
Change in brain activity during sociomoral attention switching
Description
MRI Task- analysis of imaging (fMRI) data
Time Frame
Baseline, immediately following TMS A, immediately following TMS B
Title
Change in brain activity during cue reactivity
Description
MRI Task- analysis of imaging (fMRI) data
Time Frame
Baseline, immediately following TMS A, immediately following TMS B
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
1. Age 19 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:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
SCAMPI Lab
Phone
334-521-2807
Email
scampi@auburn.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Samantha J Fede, PhD
Organizational Affiliation
Principal Investigator
Official's Role
Principal Investigator
Facility Information:
Facility Name
Auburn University
City
Auburn
State/Province
Alabama
ZIP/Postal Code
36849
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
SCAMPI Lab
Phone
334-521-2807
Email
scampi@auburn.edu
First Name & Middle Initial & Last Name & Degree
Samantha J Fede, PhD
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
Learn more about this trial
Influence of TMS on Attention Modulation
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