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

Healthy Volunteer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02560142
• Other study ID #: BP29791
• Status: Completed
• Phase: N/A
• First received: September 24, 2015
• Last updated: February 28, 2017
• Start date: August 2015
• Est. completion date: February 2016

Study information

• Verified date: February 2017
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Volunteer

Locations

Country	Name	City	State
Netherlands	PRA Health Sciences Early Development Services	Zuidlaren

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intra Class Coefficient of Correlation (ICC) of the Task Activated Blood Oxygenation Level-Dependent (BOLD) fMRI: Face Matching Task		Day 1
Primary	ICC of the Task Activated BOLD fMRI: Monetary Incentive Delay Task		Day 1
Primary	ICC of the Task Activated BOLD fMRI: 2 vs 0 Back Working Memory Task		Day 1
Primary	ICC of the Task Activated BOLD fMRI: Episodic memory Task (Encoding, Recall, and Recognition of Face-Profession Pairs)		Day 1
Primary	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
Primary	ICC of the Resting-State BOLD fMRI, Acquired Using Gradient Echo-Planar Imaging (EPI) Images		Screening (Day -28 to Day -1)
Primary	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)
Primary	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
Primary	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
Primary	Out of Scanner Behavioral Tasks: RAVEN General Intelligence Test		Screening (Day -28 to Day -1)
Primary	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
Primary	ICC of the out of Scanner Behavioral Tasks: Reward Learning Tasks (Reinforcement Learning and Working Memory Task)		Day 2
Primary	ICC of the Task Activated BOLD fMRI: Go/No-Go Task		Day 1