Healthy VolunteerNCT02560142
A Non-interventional Functional Magnetic Resonance Imaging (fMRI) Study and Behavioral Assessment in Healthy Participants
An observational study of Healthy Volunteer, run by Hoffmann-La Roche at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer
- How many people
- 31 participants
- Where
- 1 siteNetherlands
- Study dates
- Aug 2015to Feb 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Healthy Participants
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
PRA Health Sciences Early Development Services
Zuidlaren, 9471 GP
About this study
Official title: Non-Drug, Single Site, fMRI and Behavior Assessment Optimization Study in Healthy Volunteers
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).
- Conditions
- Healthy Volunteer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| All Participants | Healthy participants will undergo behavioral assessment and fMRI. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intra Class Coefficient of Correlation (ICC) of the Task Activated Blood Oxygenation Level-Dependent (BOLD) fMRI: Face Matching Task
Measured: Day 1
ICC of the Task Activated BOLD fMRI: Monetary Incentive Delay Task
Measured: Day 1
ICC of the Task Activated BOLD fMRI: 2 vs 0 Back Working Memory Task
Measured: Day 1
ICC of the Task Activated BOLD fMRI: Episodic memory Task (Encoding, Recall, and Recognition of Face-Profession Pairs)
Measured: 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)
Measured: Day 1
ICC of the Resting-State BOLD fMRI, Acquired Using Gradient Echo-Planar Imaging (EPI) Images
Measured: 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
Measured: 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
Measured: 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
Measured: Day 2
Out of Scanner Behavioral Tasks: RAVEN General Intelligence Test
Measured: 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
Measured: Day 1
ICC of the out of Scanner Behavioral Tasks: Reward Learning Tasks (Reinforcement Learning and Working Memory Task)
Measured: Day 2
ICC of the Task Activated BOLD fMRI: Go/No-Go Task
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2015 (estimated)
- Study startAug 2015
- Primary completionFeb 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteerStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02560142
- Sponsor's protocol ID
- BP29791
- Status last verified
- Feb 2017
- First submitted
- 24 Sep 2015
- Last updated
- 1 Mar 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-Drug, Single Site, fMRI and Behavior Assessment Optimization Study in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT02560142
- Acronym / sponsor ID
- BP29791
- Conditions
- Healthy Volunteer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Aug 2015
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 25 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All Participants | – | –Healthy participants will undergo behavioral assessment and fMRI. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy Participants
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Intra Class Coefficient of Correlation (ICC) of the Task Activated Blood Oxygenation Level-Dependent (BOLD) fMRI: Face Matching Task
Time frame: Day 1
ICC of the Task Activated BOLD fMRI: Monetary Incentive Delay Task
Time frame: Day 1
ICC of the Task Activated BOLD fMRI: 2 vs 0 Back Working Memory Task
Time frame: Day 1
ICC of the Task Activated BOLD fMRI: Episodic memory Task (Encoding, Recall, and Recognition of Face-Profession Pairs)
Time frame: 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)
Time frame: Day 1
ICC of the Resting-State BOLD fMRI, Acquired Using Gradient Echo-Planar Imaging (EPI) Images
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Day 2
Out of Scanner Behavioral Tasks: RAVEN General Intelligence Test
Time frame: 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
Time frame: Day 1
ICC of the out of Scanner Behavioral Tasks: Reward Learning Tasks (Reinforcement Learning and Working Memory Task)
Time frame: Day 2
ICC of the Task Activated BOLD fMRI: Go/No-Go Task
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2017.
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Irritability
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Hoffmann-La Roche
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy Volunteer, run by Hoffmann-La Roche at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intra Class Coefficient of Correlation (ICC) of the Task Activated Blood Oxygenation Level-Dependent (BOLD) fMRI: Face Matching Task (time frame: Day 1). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2017.