Ignite Creation Date:
2024-05-06 @ 3:02 AM
Last Modification Date:
2024-10-26 @ 11:27 AM
Study NCT ID:
NCT02193425
Status:
COMPLETED
Last Update Posted:
2024-07-03
First Post:
2014-07-16
Brief Title:
Reliability of the Human Brain Connectome
Sponsor:
National Institute on Alcohol Abuse and Alcoholism NIAAA
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Reliability Of The Human Brain Connectome
Status:
COMPLETED
Status Verified Date:
2024-04-19
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Background
- Magnetic resonance imaging MRI is used to investigate brain function Researchers want to use MRI to better understand the function patterns and connections between brain regions in healthy people This might help people with brain diseases in the future
Objectives
To evaluate MRI methods performed twice on the same day
To evaluate brain function using positron emission tomography PET
Eligibility
- Healthy volunteers at least 18 years old
Design
Visit 1
Participants will be screened with medical history physical exam and interview about drug and alcohol use and psychiatric history
They will give blood and urine samples Their breath will be tested for alcohol and smoking
Visit 2
Participants will have urine collected They will have MRI scans some while resting some while doing tasks on a computer
The MRI scanner is a metal cylinder in a strong magnetic field Participants will lie on a table that slides in and out of the cylinder with a coil over their head Participants will get earplugs for loud noises
Visit 3
Participants will have urine collected
A needle will guide a thin plastic tube catheter into each arm The needle will be removed leaving the catheter in the vein
Participants will then have a PET scan They will get the chemical 18FDG in the catheter They will lie on a bed that slides in and out of the PET scanner with a cap on their head
Participants may have tests of memory attention concentration and thinking They may complete interviews questionnaires tests on paper or computer and simple actions
Participants will wear a device for 1 week between visits to measure activity and sleep
- Magnetic resonance imaging MRI is used to investigate brain function Researchers want to use MRI to better understand the function patterns and connections between brain regions in healthy people This might help people with brain diseases in the future
Objectives
To evaluate MRI methods performed twice on the same day
To evaluate brain function using positron emission tomography PET
Eligibility
- Healthy volunteers at least 18 years old
Design
Visit 1
Participants will be screened with medical history physical exam and interview about drug and alcohol use and psychiatric history
They will give blood and urine samples Their breath will be tested for alcohol and smoking
Visit 2
Participants will have urine collected They will have MRI scans some while resting some while doing tasks on a computer
The MRI scanner is a metal cylinder in a strong magnetic field Participants will lie on a table that slides in and out of the cylinder with a coil over their head Participants will get earplugs for loud noises
Visit 3
Participants will have urine collected
A needle will guide a thin plastic tube catheter into each arm The needle will be removed leaving the catheter in the vein
Participants will then have a PET scan They will get the chemical 18FDG in the catheter They will lie on a bed that slides in and out of the PET scanner with a cap on their head
Participants may have tests of memory attention concentration and thinking They may complete interviews questionnaires tests on paper or computer and simple actions
Participants will wear a device for 1 week between visits to measure activity and sleep
Detailed Description:
PrSqrRootCopyrightcis
Objectives The overarching goal of this study is to quantify the reproducibility of multiple measures of brain functional connectivity FC during resting conditions and during task performance Secondary objectives are to assess the dynamic properties and energy requirements of the human brain connectome as well as the effects of physiologic noise gender and aging on measures of brain functional connectivity at rest and during task performance
Study population 60 healthy males and 60 healthy females 18 years or older will be included
Design Participants will undergo two MRIMRS sessions to evaluate test-retest reliability of FC at rest as well as during task performance and one 18F-Fluorodeoxyglucose FDG-PET session to assess the association between FC and glucose metabolism in the human brain
Outcome parameters The variability of the gender and aging effects on FC measures lFCD L C and S collected in RS and TS conditions which will be quantified using volxelwise ICC 31 The variability of brain metabolite concentrations in precuneus
Objectives The overarching goal of this study is to quantify the reproducibility of multiple measures of brain functional connectivity FC during resting conditions and during task performance Secondary objectives are to assess the dynamic properties and energy requirements of the human brain connectome as well as the effects of physiologic noise gender and aging on measures of brain functional connectivity at rest and during task performance
Study population 60 healthy males and 60 healthy females 18 years or older will be included
Design Participants will undergo two MRIMRS sessions to evaluate test-retest reliability of FC at rest as well as during task performance and one 18F-Fluorodeoxyglucose FDG-PET session to assess the association between FC and glucose metabolism in the human brain
Outcome parameters The variability of the gender and aging effects on FC measures lFCD L C and S collected in RS and TS conditions which will be quantified using volxelwise ICC 31 The variability of brain metabolite concentrations in precuneus
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 14-AA-0144 | None | None | None |