A Non-interventional Functional Magnetic Resonance Imaging (fMRI) Study and Behavioral Assessment in Healthy Participants

Study Overview
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Brief Summary
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This is a single center non-interventional study in healthy participants for behavioral assessment and fMRI assessments. The study will consist of 2 parts. Part A will involve 5 participants and will study the implementation of the behavioral tests and identify potential issues. Part B will involve 30 participants and will study the test-retest reliability. Duration of participation for each participant will be 30 days for Part A (28 days screening period and 2 days of study visit) and 48 days for Part B (28 days screening period and 2 study visits of 2 days each separated by a period of 14 days).

Official Title
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Non-Drug, Single Site, fMRI and Behavior Assessment Optimization Study in Healthy Volunteers

Conditions
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Healthy Volunteer

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy participants, as determined by screening assessments and principal investigator judgment A body mass index (BMI) between 18 to 30 kilogram per square meter (kg/m^2) inclusive with body weight in the range of 50 to 100 kg The participant must be able to comply with study requirements as judged by the principal investigator Women participants who are not postmenopausal or surgically sterile agree to use effective contraception throughout the study Exclusion Criteria: Female participant with child-bearing potential or a positive blood pregnancy test Lactating women participants Any history of alcohol and/or drug abuse, addiction or suspicion of regular consumption of drugs of abuse Use of any psychoactive medication, or medications known to have effect on central nervous system (CNS) or blood flow Any contraindications for magnetic resonance imaging (MRI) scans or any brain/head abnormalities restricting MRI eligibility

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| All Participants<br>Healthy participants will undergo behavioral assessment and fMRI. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intra Class Coefficient of Correlation (ICC) of the Task Activated Blood Oxygenation Level-Dependent (BOLD) fMRI: Face Matching Task |  | Day 1 | 
| ICC of the Task Activated BOLD fMRI: Monetary Incentive Delay Task |  | Day 1 | 
| ICC of the Task Activated BOLD fMRI: 2 vs 0 Back Working Memory Task |  | Day 1 | 
| ICC of the Task Activated BOLD fMRI: Episodic memory Task (Encoding, Recall, and Recognition of Face-Profession Pairs) |  | Day 1 | 
| ICC of the Task Activated BOLD fMRI: Theory of Mind Task (ToM; To Make Inferences About Others Mental States Using 32 False-Belief Cartoon Stories) |  | Day 1 | 
| ICC of the Resting-State BOLD fMRI, Acquired Using Gradient Echo-Planar Imaging (EPI) Images |  | Screening (Day -28 to Day -1) | 
| ICC of the Resting-State Arterial Spin Labeling (ASL) to Measure Cerebral Blood Flow, Acquired Using Gradient EPI Images |  | Screening (Day -28 to Day -1) | 
| ICC of the out of Scanner Behavioral Tasks: Stop Signal Reaction Time (SSRT) to Assess the Time Required to Stop Already Executed Response |  | Day 1 | 
| ICC of the out of Scanner Behavioral Tasks: California Verbal Learning Test - Second Edition (CVLT-II), to Assess an Individual's Episodic Verbal Learning and Memory Abilities |  | Day 2 | 
| Out of Scanner Behavioral Tasks: RAVEN General Intelligence Test |  | Screening (Day -28 to Day -1) | 
| ICC of the out of Scanner Behavioral Tasks: Emotional Test Battery (ETB), Assessed Using Facial Expression Recognition Task (FERT) and Faces Dot Probe Task (FDOT) to Measure Biases in Emotional Processing |  | Day 1 | 
| ICC of the out of Scanner Behavioral Tasks: Reward Learning Tasks (Reinforcement Learning and Working Memory Task) |  | Day 2 | 
| ICC of the Task Activated BOLD fMRI: Go/No-Go Task |  | Day 1 |