A Non-interventional Functional Magnetic Resonance Imaging (fMRI) Study and Behavioral Assessment in Healthy Participants
Completed
- Conditions
- Healthy Volunteer
- Registration Number
- NCT02560142
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 31
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
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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
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Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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: Episodic memory Task (Encoding, Recall, and Recognition of Face-Profession Pairs) 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 Task Activated BOLD fMRI: 2 vs 0 Back Working Memory Task 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 Task Activated BOLD fMRI: Monetary Incentive Delay Task 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
PRA Health Sciences Early Development Services
🇳🇱Zuidlaren, Netherlands