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Clinical Trials/NCT05611502
NCT05611502
Recruiting
Not Applicable

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

Auburn University1 site in 1 country40 target enrollmentAugust 11, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Drinking, Alcohol
Sponsor
Auburn University
Enrollment
40
Locations
1
Primary Endpoint
Change in sociomoral attention switching
Status
Recruiting
Last Updated
6 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 11, 2022
End Date
December 31, 2025
Last Updated
6 months ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Samantha Fede

Assistant Professor

Auburn University

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

  • 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

Outcomes

Primary Outcomes

Change in sociomoral attention switching

Time Frame: Baseline, immediately following TMS A, immediately following TMS B

MRI Task- analysis of behavioral data

Change in cue reactivity

Time Frame: Baseline, immediately following TMS A, immediately following TMS B

MRI Task- analysis of behavioral data

Change in attention switching

Time Frame: Baseline, immediately following TMS A, immediately following TMS B

MRI Task- analysis of behavioral data

Secondary Outcomes

  • Change in brain activity during cue reactivity(Baseline, immediately following TMS A, immediately following TMS B)
  • 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)

Study Sites (1)

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