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Brain Stimulation

Brain Stimulation for Alcohol Misuse (FLAME Trial)

N/A

Recruiting

Led By Charlotte A Boettiger, PhD

Research Sponsored by University of North Carolina, Chapel Hill

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

22-50 years old

Be between 18 and 65 years old

Must not have

Neurological disease such as dementia, seizures or head trauma

Any history of brain surgery

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at study completion, an average of 2 weeks

Summary

This trial aims to see if a non-invasive brain stimulation can change brain activity in the prefrontal cortex and affect decision-making habits. They want to know if this stimulation can reduce habitual actions,

Who is the study for?

This trial is for healthy adults who have a history of alcohol use, including those who may binge-drink. Participants will undergo brain stimulation sessions and complete tasks at a lab. They must be willing to provide blood samples and attend MRI sessions.

What is being tested?

The study tests if alpha-tACS, a non-invasive brain stimulation, can influence the prefrontal cortex and change habitual actions related to alcohol use. It compares this method with sham (fake) stimulation to see if there's an actual effect on behavior.

What are the potential side effects?

While not explicitly stated, side effects of tACS could include mild discomfort or skin irritation where electrodes are placed, headache, fatigue or dizziness during or after treatment.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 22 and 50 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a neurological condition like dementia, seizures, or head trauma.

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I have had brain surgery in the past.

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I have a close family member with epilepsy.

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I do not have any issues with movement or sight that would stop me from doing tasks.

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I have a history of psychosis or psychotic episodes.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at study completion, an average of 2 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at study completion, an average of 2 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and at study completion, an average of 2 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in habitual action selection

Prefrontal GABA:glutamate/glutamine ratio

Secondary study objectives

Control circuit functional connectivity

Inflammatory markers

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: 10Hz bi-frontal tACSExperimental Treatment1 Intervention

For Session 3, participants will complete a Habitual Association between Images Task (HABIT) Test Session in the Howell Hall Neurostimulation Core Lab or electroencephalogram (EEG) Core Lab, which is located one floor below the Boettiger Lab. Participants will receive either 10Hz bi-frontal transcranial alternating current stimulation (tACS) or sham tACS. 10 Hz bi-frontal tACS: Alternating current stimulation is delivered by an XCSITE 100 device (Pulvinar Neuro, Chapel Hill, NC), through three conductive carbon-rubber electrodes. Electrodes are placed over the apex of the head (Cz) and the prefrontal cortex bilaterally (F3 and F4). Stimulation is delivered during the second half of the HABIT Test session. Stimulation parameters: 2mA peak-to-peak 10Hz sine-wave flanked by 10 second linear envelope ramps in and out for a total duration of 30 min and 20 seconds.

Group II: sham tACSPlacebo Group1 Intervention

Sham transcranial alternating current stimulation (tACS): The procedure for sham stimulation will be identical, but the actual stimulation will last for 2 minutes instead of 30 minutes. Participants generally report that stimulation is felt most strongly at the beginning of active stimulation, before they adjust to the sensation. Sham stimulation is meant to mimic this progression in terms of tactile salience. Stimulation is delivered for 2 minutes at the beginning of the HABIT reversal task, flanked by 10 second linear envelope ramps. The stimulating electrodes are left on the head until completion of the HABIT task, as is the case in active stimulation. There is no visual or auditory indication to the participant or researcher when the 2-minute sham stimulation period has ended, allowing the sham stimulation condition to feel similar to active stimulation.

0 / 6Eligibility criteria met