Influence of TMS on Attention Modulation

Drinking, Alcohol Clinical Trial

— TAM  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05611502
• Other study ID #: 21510
• Secondary ID: R00AA027830
• Status: Recruiting
• Phase: N/A
• Start date: August 11, 2022
• Est. completion date: December 15, 2024

Study information

• Verified date: December 2023
• Source: Auburn University
• Contact: SCAMPI Lab
• Phone: 334-521-2807
• Email: scampi[@]auburn.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 15, 2024
• Est. primary completion date: December 15, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Alcohol Drinking
• Drinking, Alcohol

Intervention

Device:
• TMS
TMS will be administered in a pattern that is either excitatory or inhibitory.

Locations

Country	Name	City	State
United States	Auburn University	Auburn	Alabama

Sponsors (2)

Lead Sponsor	Collaborator
Auburn University	National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in attention switching	MRI Task- analysis of behavioral data	Baseline, immediately following TMS A, immediately following TMS B
Primary	Change in sociomoral attention switching	MRI Task- analysis of behavioral data	Baseline, immediately following TMS A, immediately following TMS B
Primary	Change in cue reactivity	MRI Task- analysis of behavioral data	Baseline, immediately following TMS A, immediately following TMS B
Secondary	Change in brain activity attention switching	MRI Task- analysis of imaging (fMRI) data	Baseline, immediately following TMS A, immediately following TMS B
Secondary	Change in brain activity during sociomoral attention switching	MRI Task- analysis of imaging (fMRI) data	Baseline, immediately following TMS A, immediately following TMS B
Secondary	Change in brain activity during cue reactivity	MRI Task- analysis of imaging (fMRI) data	Baseline, immediately following TMS A, immediately following TMS B