A Non-interventional Functional Magnetic Resonance Imaging (fMRI) Study and Behavioral Assessment in Healthy Participants
28. februar 2017 opdateret af: Hoffmann-La Roche
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).
Studieoversigt
Status
Afsluttet
Betingelser
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
31
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Zuidlaren, Holland, 9471 GP
- PRA Health Sciences Early Development Services
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 45 år (Voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
Healthy Participants
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
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All Participants
Healthy participants will undergo behavioral assessment and fMRI.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
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Intra Class Coefficient of Correlation (ICC) of the Task Activated Blood Oxygenation Level-Dependent (BOLD) fMRI: Face Matching Task
Tidsramme: Day 1
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Day 1
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ICC of the Task Activated BOLD fMRI: Monetary Incentive Delay Task
Tidsramme: Day 1
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Day 1
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ICC of the Task Activated BOLD fMRI: 2 vs 0 Back Working Memory Task
Tidsramme: Day 1
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Day 1
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ICC of the Task Activated BOLD fMRI: Episodic memory Task (Encoding, Recall, and Recognition of Face-Profession Pairs)
Tidsramme: Day 1
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Day 1
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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)
Tidsramme: Day 1
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Day 1
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ICC of the Resting-State BOLD fMRI, Acquired Using Gradient Echo-Planar Imaging (EPI) Images
Tidsramme: Screening (Day -28 to Day -1)
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Screening (Day -28 to Day -1)
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ICC of the Resting-State Arterial Spin Labeling (ASL) to Measure Cerebral Blood Flow, Acquired Using Gradient EPI Images
Tidsramme: Screening (Day -28 to Day -1)
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Screening (Day -28 to Day -1)
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ICC of the out of Scanner Behavioral Tasks: Stop Signal Reaction Time (SSRT) to Assess the Time Required to Stop Already Executed Response
Tidsramme: Day 1
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Day 1
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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
Tidsramme: Day 2
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Day 2
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Out of Scanner Behavioral Tasks: RAVEN General Intelligence Test
Tidsramme: Screening (Day -28 to Day -1)
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Screening (Day -28 to Day -1)
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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
Tidsramme: Day 1
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Day 1
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ICC of the out of Scanner Behavioral Tasks: Reward Learning Tasks (Reinforcement Learning and Working Memory Task)
Tidsramme: Day 2
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Day 2
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ICC of the Task Activated BOLD fMRI: Go/No-Go Task
Tidsramme: Day 1
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Day 1
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. august 2015
Primær færdiggørelse (Faktiske)
1. februar 2016
Studieafslutning (Faktiske)
1. februar 2016
Datoer for studieregistrering
Først indsendt
24. september 2015
Først indsendt, der opfyldte QC-kriterier
24. september 2015
Først opslået (Skøn)
25. september 2015
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
1. marts 2017
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
28. februar 2017
Sidst verificeret
1. februar 2017
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- BP29791
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .