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Protocol Details

Reliability Of The Human Brain Connectome

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

14-AA-0144

Sponsoring Institute

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 21
Max Age: 85

Referral Letter Required

No

Population Exclusion(s)

Children

Special Instructions

Currently Not Provided

Keywords

Brain;
Connectivity;
PET;
fcMRI;
18FDG

Recruitment Keyword(s)

None

Condition(s)

Functional Connectivity

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

Drug: F-18FDG
Device: MRI

Supporting Site

National Institute on Alcohol Abuse and Alcoholism

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.

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Eligibility

INCLUSION CRITERIA:

All Participants:

1. Older than 18 years of age.

2. Ability to provide written informed consent as determined by physical examination and verbal communication. Capacity to consent will be determined by those obtaining the informed consent

EXCLUSION CRITERIA:

1. Pregnant or breast feeding. Females of childbearing potential must have negative urine pregnancy test and not be currently breastfeeding. Post-menopausal or surgically sterile (tubal ligation or hysterectomy) females satisfy these criteria.

2. Use, in the past two weeks, of psychoactive medications (four weeks for fluoxetine) or medication that can affect brain function (including but not limited to meperidine, tricyclic antidpressants, selective serotonin reuptake inhibitors (SSRIs), or serotonin norepinephrine reuptake inhibitors (SNRIs) as determined by history and clinical exam.

3. Current or past DSM-IV or DSM-5 diagnosis of a psychiatric disorder as determined by history and clinical exam including substance use disorder (except for nicotine/caffeine), alcoholism and alcohol dependence. Those with a binge drinking history in the last 10 years will also be excluded. Past history of a mental disorder as defined by DSM-IV or DSM-5 will be excluded only if it required hospitalization (any length), or chronic medication management (more than 4 weeks), and that could impact brain function at the time of the study. Binge drinkers are those who being female consume 4 or more drinks and males 5 or more drinks in one occasion at least once a month.

4. Major medical problems that can impact brain function at the time of the scan (including but not limited to HIV; central nervous system including seizures and psychosis; cardiovascular including hypertension and arrhythmias; metabolic, autoimmune, endocrine) as determined by history and clinical exam.

5. Any clinically significant laboratory finding as determined during the screening procedures.

6. Have had previous radiation exposure (from X-rays, PET scans, or other exposure) that, with the exposure from this study, would exceed NIH annual research limits.

7. Head trauma with loss of consciousness for more than 30 minutes.

8. Presence of ferromagnetic objects in the body that are contraindicated for MRI/MRS of the head (pacemakers or other implanted electrical devices, brain stimulators, some types of dental implants, aneurysm clips, metallic prostheses, permanent eyeliner, implanted delivery pump, or shrapnel fragments), fear of enclosed spaces, or other standard contraindication to MRI/MRS (self-report checklist).

9. Cannot lie comfortably flat on back for up to 2 hours in the PET and MRI/MRS scanners.

10. Body weight > 250 kg. This is the upper limit that the bed of the MR scanner can accommodate.

11. NIH employees who are study investigators, as well as their superiors, subordinates and immediate family members (adult children, spouses, parents, siblings).

* Subjects will not be excluded from enrollment onto this study if their urine test is positive for drugs. However, if they test positive on scheduled study procedure days involving study imaging (MRI/MRS and PET) and Neuropsychological testing, the procedures will be postponed and rescheduled. We will allow for up to 3 rescheduled study days that were the result of positive urine drug screens. If the drug test is positive on the third rescheduled visit, the participant will be withdrawn from the study.


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Citations:

Sporns O. The human connectome: a complex network. Ann N Y Acad Sci. 2011 Apr;1224:109-25. doi: 10.1111/j.1749-6632.2010.05888.x. Epub 2011 Jan 4.

Lu H, Stein EA. Resting state functional connectivity: Its physiological basis and application in neuropharmacology. Neuropharmacology. 2013 Sep 4. pii: S0028-3908(13)00390-0. doi: 10.1016/j.neuropharm.2013.08.023.

Kelly C, Biswal BB, Craddock RC, Castellanos FX, Milham MP. Characterizing variation in the functional connectome: promise and pitfalls. Trends Cogn Sci. 2012 Mar;16(3):181-8. doi: 10.1016/j.tics.2012.02.001. Epub 2012 Feb 15.

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Contacts:

Principal Investigator

Referral Contact

For more information:

Dardo G. Tomasi
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
National Institutes of Health
Building 10
Room B2L304
10 Center Drive
Bethesda, Maryland 20892
(301) 496-1589
dardo.tomasi@nih.gov

Dardo G. Tomasi
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
National Institutes of Health
Building 10
Room B2L304
10 Center Drive
Bethesda, Maryland 20892
(301) 496-1589
dardo.tomasi@nih.gov

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: 1-866-411-1010
PRPL@cc.nih.gov

Clinical Trials Number:

NCT02193425

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