NCT02193425

Reliability of the Human Brain Connectome

Completed EARLY_PHASE1 Last updated 27 March 2026

What this trial tests

EARLY_PHASE1 trial testing F-18FDG in Normal Physiology in 112 participants. Completed in 23 May 2023.

Timeline

8 June 2015

Primary endpoint
23 May 2023

23 May 2023

Quick facts

Lead sponsor	National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Phase	EARLY_PHASE1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	basic science
Enrollment	112
Start date	8 June 2015
Primary completion	23 May 2023
Estimated completion	23 May 2023
Sites	1 location across United States

Drugs / interventions tested

• F-18FDG — full drug profile →
• MRI — full drug profile →

Conditions studied

• Normal Physiology — all drugs for Normal Physiology →

Sponsor

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Who can join

18 and older, any sex, with Normal Physiology. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Correspondence between cerebral glucose metabolism and BOLD reveals relative power and cost in human brain.
   Shokri-Kojori E, Tomasi D, Alipanahi B, Wiers CE, et al · · 2019 · cited 79× · PMID 30741935 · DOI 10.1038/s41467-019-08546-x
2. Comprehensive Evaluation of Healthy Volunteers Using Multi-Modality Brain Injury Assessments: An Exploratory, Observational Study.
   Weaver LK, Wilson SH, Lindblad AS, Churchill S, et al · · 2018 · cited 2× · PMID 30631299 · DOI 10.3389/fneur.2018.01030