Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06634771
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-10-03
Brief Title:
Flexibility Alcohol Misuse and Excitation
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Frontal EI Balance Mediation of TACS Effects on Behavioral Flexibility
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FLAME
Brief Summary:
The goal of this study is to learn whether a single non-invasive brain stimulation alpha-transcranial alternating current stimulation alpha-tACS session changes measures of excitability in the prefrontal cortex It will also learn whether these changes predict differences in habitual action selection in a laboratory task and whether the effects depend on alcohol use history The main questions it aims to answer are
Does alpha-tACS reduce habitual action selection by reducing excitability in the prefrontal cortex Is alpha-tACS most effective in reducing habitual action selection in hazardous drinkers who engaged in binge-drinking during adolescence
Researchers will compare alpha-tACS to sham stimulation to see if alpha-tACS changes habitual action selection by changing prefrontal excitability
Participants will
Visit the lab for behavioral training Visit the imaging center for an MRI session Visit the lab to receive alpha-tACS or sham stimulation during behavioral testing and undergo EEG recordings before and after stimulation Visit the imaging center for a repeat MRI session Provide a small sample of blood from a finger-prick in the first and last visits
Does alpha-tACS reduce habitual action selection by reducing excitability in the prefrontal cortex Is alpha-tACS most effective in reducing habitual action selection in hazardous drinkers who engaged in binge-drinking during adolescence
Researchers will compare alpha-tACS to sham stimulation to see if alpha-tACS changes habitual action selection by changing prefrontal excitability
Participants will
Visit the lab for behavioral training Visit the imaging center for an MRI session Visit the lab to receive alpha-tACS or sham stimulation during behavioral testing and undergo EEG recordings before and after stimulation Visit the imaging center for a repeat MRI session Provide a small sample of blood from a finger-prick in the first and last visits
Detailed Description:
This study is designed to probe the role of the balance between excitatory E and inhibitory I signaling EI in key nodes of control circuitry in mediating the relationship between alcohol misuse and inflexible behavior In addition the investigators aim to determine whether adolescent binge alcohol exposure amplifies the effects of binge exposure in adulthood The investigators will accomplish this goal via a single multi-session study Participants n66 will comprise three groups adults self-reporting high risk drinking World Health Organization WHO risk levels 2 3 or 4 with n22 or without n22 a history of adolescent alcohol misuse AIE and lifetime low risk drinking adults WHO risk levels 0 or 1 n22
Design a 3-session study that includes an initial screening session and behavioral training Session 1 behavioral testing and a magnetic resonance imaging MRI scan session Session 2 bifrontal 10Hz-transcranial alternating current stimulation tACS true or sham during behavioral testing with pre- and post-electroencephalogram EEG recording in a resting-state followed by a second MRI scan session Session 3 The investigators predict that adolescent and adult binge history will have interacting effects on EI balance indices derived from EEG and magnetic resonance spectroscopy MRS and on behavioral flexibility measured in the Hidden Association between Images Task HABIT Test and that EI balance indices will mediate the relationship between alcohol misuse and behavioral flexibility The investigators also propose to test a causal relationship between EI balance and behavioral flexibility by testing whether 10Hz-tACS to bilateral dorsolateral prefrontal cortex dlPFC alters habitual action selection in the HABIT Test in proportion to its effects on the dlPFC 1f EEG slope andor the MRS-derived gamma-amino-butyric acid GABAglutamateglutamine Glx ratio The investigators predict that changes in indices of EI balance induced by tACS will inversely associate with changes in habitual response selection The investigators will collect a small amount of blood from a finger prick in Sessions 1 and 3 will use the collected dried blood spots to measure inflammatory markers
Design a 3-session study that includes an initial screening session and behavioral training Session 1 behavioral testing and a magnetic resonance imaging MRI scan session Session 2 bifrontal 10Hz-transcranial alternating current stimulation tACS true or sham during behavioral testing with pre- and post-electroencephalogram EEG recording in a resting-state followed by a second MRI scan session Session 3 The investigators predict that adolescent and adult binge history will have interacting effects on EI balance indices derived from EEG and magnetic resonance spectroscopy MRS and on behavioral flexibility measured in the Hidden Association between Images Task HABIT Test and that EI balance indices will mediate the relationship between alcohol misuse and behavioral flexibility The investigators also propose to test a causal relationship between EI balance and behavioral flexibility by testing whether 10Hz-tACS to bilateral dorsolateral prefrontal cortex dlPFC alters habitual action selection in the HABIT Test in proportion to its effects on the dlPFC 1f EEG slope andor the MRS-derived gamma-amino-butyric acid GABAglutamateglutamine Glx ratio The investigators predict that changes in indices of EI balance induced by tACS will inversely associate with changes in habitual response selection The investigators will collect a small amount of blood from a finger prick in Sessions 1 and 3 will use the collected dried blood spots to measure inflammatory markers
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None