Reliability of the Human Brain Connectome

Normal Physiology Clinical Trial

Official title: Reliability Of The Human Brain Connectome

Status Completed

Clinical Trial 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.

Clinical Trial Description

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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 MRI/MRS 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 (3,1). The variability of brain metabolite concentrations in precuneus. ;

Related Conditions & MeSH terms

• Normal Physiology

• NCT number: NCT02193425
• Study type: Interventional
• Source: National Institutes of Health Clinical Center (CC)
• Status: Completed
• Phase: Early Phase 1
• Start date: June 8, 2015
• Completion date: May 23, 2023