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Reliability of the Human Brain Connectome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02193425
Recruitment Status : Recruiting
First Posted : July 17, 2014
Last Update Posted : October 14, 2020
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute on Alcohol Abuse and Alcoholism (NIAAA) )

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.

Condition or disease Intervention/treatment Phase
Normal Physiology Drug: F-18FDG Device: MRI Early Phase 1

Detailed Description:

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. The variability of brain metabolite concentrations in precuneus.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Reliability Of The Human Brain Connectome
Actual Study Start Date : June 8, 2015
Estimated Primary Completion Date : December 31, 2025
Estimated Study Completion Date : December 31, 2025

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: PET FDG & MRI Scans
The test-retest reproducibility of the gender and aging effects on FC measures (lFCD, C, L and S) acquired in RS and TS conditions.
Drug: F-18FDG
18F- Fluorodeoxyglucose (FDG)-PET session to assess the association between functional connectivity (FC) and glucose metabolism in the human brain.

Device: MRI
Two MRI/MRS sessions to evaluate test-retest reliability of functional connectivity (FC) at rest as well as during task performance.




Primary Outcome Measures :
  1. The overaching goal of this study is to quantify the reproducibility of multiple measures of brain functional connectivity (FC) during resting conditions and during task performance. [ Time Frame: end of study ]
    The test-retest reproducibility of the gender and aging effects on FC measures (lFCD, C, L and S) acquired in RS and TS conditions.


Secondary Outcome Measures :
  1. The correlation between glucose metabolism, CBF, lFCD, C, L and S and its contribution to between- subjects FC-variability during RS. [ Time Frame: end of study ]
    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.

  2. The association between IFCD and the underlying structural connectivity and its contribution to between- subjects FC-variability during RS. [ Time Frame: end of study ]
    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

  3. The correlation between physiologic noise and FC measures (lFCD, C, L and S) and its contribution to within- subjects FC-variability during RS and TS conditions. [ Time Frame: end of study ]
    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

  4. The dynamics of the FC measures (lFCD, C, L and S) and its contribution to within- subjects FC-variability during RS and TS conditions. [ Time Frame: end of study ]
    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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria
  • 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. The following current chronically used (within 2 months of study procedures) psychoactive medications or medications that can affect brain function (including but not limited to meperidine, tricyclic antidpressants, selective serotonin reuptake inhibitors (SSRIs), or serotonin norepinephrine reuptake inhibitors (SNRIs), stimulant or stimulant-like medications (amphetamine, methylphenidate, modafinil); opioid analgesics; antianginal agents; antiarrhythmics; systemic corticosteroids; anticholinergics; anticoagulants; anticonvulsants; antihistamines (sedating); beta blocker antihypertensives; antineoplastics; antiobesity; antipsychotics; anxiolytics

    (benzodiazepine or barbiturates); lithium; muscle relaxants, and systemic steroids 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. 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.
  4. Those with a binge drinking history every month continuously for the last 10 years will also be excluded. Binge drinkers are those who being female consume 4 or more drinks and males consume 5 or more drinks in one occasion at least once a month.
  5. 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. Participants aged 60 and older with any medical problems that are controlled will not be excluded.
  6. Any clinically significant laboratory finding as determined during the screening procedures.
  7. 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.
  8. Head trauma with loss of consciousness for more than 30 minutes.
  9. 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).
  10. Cannot lie comfortably flat on back for up to 2 hours in the PET and MRI/MRS scanners.
  11. Body weight > 250 kg. This is the upper limit that the bed of the MR scanner can accommodate.
  12. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02193425


Contacts
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Contact: Dardo G Tomasi, Ph.D. (301) 496-1589 dardo.tomasi@nih.gov

Locations
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United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)    800-411-1222 ext TTY8664111010    prpl@cc.nih.gov   
Sponsors and Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Investigators
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Principal Investigator: Dardo G Tomasi, Ph.D. National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Additional Information:
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Responsible Party: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
ClinicalTrials.gov Identifier: NCT02193425    
Other Study ID Numbers: 140144
14-AA-0144
First Posted: July 17, 2014    Key Record Dates
Last Update Posted: October 14, 2020
Last Verified: September 18, 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Institutes of Health Clinical Center (CC) ( National Institute on Alcohol Abuse and Alcoholism (NIAAA) ):
fMRI
Brain Connectivity
PET
18FDG
Additional relevant MeSH terms:
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Fluorodeoxyglucose F18
Radiopharmaceuticals
Molecular Mechanisms of Pharmacological Action