Clinical trial NCT02560142: A Non-interventional Functional Magnetic Resonance Imaging (fMRI) Study and Behavioral Assessment in Healthy Participants
Official title: Non-Drug, Single Site, fMRI and Behavior Assessment Optimization Study in Healthy Volunteers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy Volunteer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2015-09-25
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy Participants

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).


Eligibility criteria: 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

Primary outcomes:
measure: Intra Class Coefficient of Correlation (ICC) of the Task Activated Blood Oxygenation Level-Dependent (BOLD) fMRI: Face Matching Task
timeFrame: Day 1
measure: ICC of the Task Activated BOLD fMRI: Monetary Incentive Delay Task
timeFrame: Day 1
measure: ICC of the Task Activated BOLD fMRI: 2 vs 0 Back Working Memory Task
timeFrame: Day 1
measure: ICC of the Task Activated BOLD fMRI: Episodic memory Task (Encoding, Recall, and Recognition of Face-Profession Pairs)
timeFrame: Day 1
measure: 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)
timeFrame: Day 1
measure: ICC of the Resting-State BOLD fMRI, Acquired Using Gradient Echo-Planar Imaging (EPI) Images
timeFrame: Screening (Day -28 to Day -1)
measure: ICC of the Resting-State Arterial Spin Labeling (ASL) to Measure Cerebral Blood Flow, Acquired Using Gradient EPI Images
timeFrame: Screening (Day -28 to Day -1)
measure: ICC of the out of Scanner Behavioral Tasks: Stop Signal Reaction Time (SSRT) to Assess the Time Required to Stop Already Executed Response
timeFrame: Day 1
measure: 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
timeFrame: Day 2
measure: Out of Scanner Behavioral Tasks: RAVEN General Intelligence Test
timeFrame: Screening (Day -28 to Day -1)
measure: 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
timeFrame: Day 1
measure: ICC of the out of Scanner Behavioral Tasks: Reward Learning Tasks (Reinforcement Learning and Working Memory Task)
timeFrame: Day 2
measure: ICC of the Task Activated BOLD fMRI: Go/No-Go Task
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Zuidlaren
country: Netherlands
facility: PRA Health Sciences Early Development Services
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: