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Completed

NCT Number: NCT02560142

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

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).

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Key information

Conditions

Healthy Volunteer

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Observational

Primary location

PRA Health Sciences Early Development Services

Zuidlaren, 9471 GP, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Intra Class Coefficient of Correlation (ICC) of the Task Activated Blood Oxygenation Level-Dependent (BOLD) fMRI: Face Matching Task

    Time frame: Day 1

  2. ICC of the Task Activated BOLD fMRI: Monetary Incentive Delay Task

    Time frame: Day 1

  3. ICC of the Task Activated BOLD fMRI: 2 vs 0 Back Working Memory Task

    Time frame: Day 1

  4. ICC of the Task Activated BOLD fMRI: Episodic memory Task (Encoding, Recall, and Recognition of Face-Profession Pairs)

    Time frame: Day 1

  5. 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)

    Time frame: Day 1

  6. ICC of the Resting-State BOLD fMRI, Acquired Using Gradient Echo-Planar Imaging (EPI) Images

    Time frame: Screening (Day -28 to Day -1)

  7. ICC of the Resting-State Arterial Spin Labeling (ASL) to Measure Cerebral Blood Flow, Acquired Using Gradient EPI Images

    Time frame: Screening (Day -28 to Day -1)

  8. ICC of the out of Scanner Behavioral Tasks: Stop Signal Reaction Time (SSRT) to Assess the Time Required to Stop Already Executed Response

    Time frame: Day 1

  9. 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

    Time frame: Day 2

  10. Out of Scanner Behavioral Tasks: RAVEN General Intelligence Test

    Time frame: Screening (Day -28 to Day -1)

  11. 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

    Time frame: Day 1

  12. ICC of the out of Scanner Behavioral Tasks: Reward Learning Tasks (Reinforcement Learning and Working Memory Task)

    Time frame: Day 2

  13. ICC of the Task Activated BOLD fMRI: Go/No-Go Task

    Time frame: Day 1

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Sep 25, 2015
Registry last updated
Mar 1, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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