TAM: Influence of TMS on Attention Modulation

Sponsor

Auburn University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05611502

Collaborator

National Institute on Alcohol Abuse and Alcoholism (NIAAA) (NIH)

Enrollment

Location

Arms

Anticipated Duration (Months)

3.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Drinking, Alcohol	Device: TMS	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention Model Description:

Participants will be randomly assigned to receive each arm in counterbalanced order (AB or BA).Participants will be randomly assigned to receive each arm in counterbalanced order (AB or BA).

Masking:

Single (Participant)

Primary Purpose:

Basic Science

Official Title:

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

Actual Study Start Date :

Aug 11, 2022

Anticipated Primary Completion Date :

Aug 10, 2023

Anticipated Study Completion Date :

Aug 10, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Change in attention switching [Baseline, immediately following TMS A, immediately following TMS B]
MRI Task- analysis of behavioral data
Change in sociomoral attention switching [Baseline, immediately following TMS A, immediately following TMS B]
MRI Task- analysis of behavioral data
Change in cue reactivity [Baseline, immediately following TMS A, immediately following TMS B]
MRI Task- analysis of behavioral data

Secondary Outcome Measures

Change in brain activity attention switching [Baseline, immediately following TMS A, immediately following TMS B]
MRI Task- analysis of imaging (fMRI) data
Change in brain activity during sociomoral attention switching [Baseline, immediately following TMS A, immediately following TMS B]
MRI Task- analysis of imaging (fMRI) data
Change in brain activity during cue reactivity [Baseline, immediately following TMS A, immediately following TMS B]
MRI Task- analysis of imaging (fMRI) data

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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