Clinical trial NCT05611502: Influence of TMS on Attention Modulation
Official title: A Combined Neurofeedback- TMS Intervention for Alcohol Use Disorder - Aim 2
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Drinking, Alcohol
Keywords: alcohol
attention
TMS
binge drinking
emotion
social cognition
moral
MRI
frontal eye fields
moral cognition
Lead sponsor: Auburn University
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2022-11-10
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Participants will be randomly assigned to receive each arm in counterbalanced order (AB or BA).
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in attention switching
timeFrame: Baseline, immediately following TMS A, immediately following TMS B
measure: Change in sociomoral attention switching
timeFrame: Baseline, immediately following TMS A, immediately following TMS B
measure: Change in cue reactivity
timeFrame: Baseline, immediately following TMS A, immediately following TMS B
Secondary outcomes:
measure: Change in brain activity attention switching
timeFrame: Baseline, immediately following TMS A, immediately following TMS B
measure: Change in brain activity during sociomoral attention switching
timeFrame: Baseline, immediately following TMS A, immediately following TMS B
measure: Change in brain activity during cue reactivity
timeFrame: Baseline, immediately following TMS A, immediately following TMS B
Other outcomes:
Locations:
city: Auburn
country: United States
facility: Auburn University
state: Alabama
Study officials:
affiliation: Principal Investigator
name: Samantha J Fede, PhD
role: PRINCIPAL_INVESTIGATOR
References: