Normal PhysiologyEarly Phase 1NCT02193425
Reliability of the Human Brain Connectome
A Early Phase 1 study testing F-18FDG and MRI in people with Normal Physiology, run by National Institute on Alcohol Abuse and Alcoholism (NIAAA) at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Normal Physiology
- What is being tested?
- F-18FDG and MRI
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jun 2015to 23 May 2023
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All Participants:
- Older than 18 years of age.
- 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
Who cannot join
- 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.
- 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.
- 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.
- 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.
- 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.
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- Any clinically significant laboratory finding as determined during the screening procedures.
- 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.
- Head trauma with loss of consciousness for more than 30 minutes.
- 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).
- Cannot lie comfortably flat on back for up to 2 hours in the PET and MRI/MRS scanners.
- Body weight > 250 kg. This is the upper limit that the bed of the MR scanner can accommodate.
- NIH employees who are study investigators, as well as their superiors, subordinates and immediate family members (adult children, spouses, parents, siblings).
- Non-English speakers (subjects must be able to read and comprehend English).
- 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.
- The intent of the research has no prospect of direct benefit to the subject. Therefore, we are excluding non-English speakers in this research study since it includes the administration of questionnaires, surveys and assessments that are validated for English, although some are available in Spanish.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
Official title: Reliability Of The Human Brain Connectome
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.
Read more
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.
Read the detailed description
Pr(SqrRoot)(Copyright)cis:
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.
- Conditions
- Normal Physiology
- Being tested
- F-18FDG, MRI
- Keywords
- fMRI, Brain Connectivity, PET, 18FDG
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
F-18FDGDrug
18F-Fluorodeoxyglucose (FDG)-PET session to assess the association between functional connectivity (FC) and glucose metabolism in the human brain.
MRIDevice
Two MRI/MRS sessions to evaluate test-retest reliability of functional connectivity (FC) at rest as well as during task performance.
| Study group | Role | What they receive |
|---|---|---|
| PET FDG & MRI Scans | Experimental | The test-retest reproducibility of the gender and aging effects on FC measures (lFCD, C, L and S) acquired in RS and TS conditions. Receives: Drug: F-18FDG; Device: MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
The test-retest reproducibility of the gender and aging effects on FC measures (lFCD, C, L and S) acquired in RS and TS conditions.
Measured: end of study
Secondary outcomes (4)
The correlation between glucose metabolism, CBF, lFCD, C, L and S and its contribution to between- subjects FC-variability during RS.
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.
Measured: end of study
The association between IFCD and the underlying structural connectivity and its contribution to between- subjects FC-variability during RS.
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
Measured: end of study
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.
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
Measured: end of study
The dynamics of the FC measures (lFCD, C, L and S) and its contribution to within- subjects FC-variability during RS and TS conditions.
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
Measured: end of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2014 (estimated)
- Study start8 Jun 2015
- Primary completion23 May 2023
- Study completion23 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Normal PhysiologyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Dardo G Tomasi, Ph.D., Principal investigator, National Institute on Alcohol Abuse and Alcoholism (NIAAA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02193425
- Sponsor's protocol ID
- 140144
- Other IDs
- 14-AA-0144
- Status last verified
- 30 Jan 2026
- First submitted
- 16 Jul 2014
- Last updated
- 8 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data is analyzed in groups so no individual information will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reliability Of The Human Brain Connectome
- ClinicalTrials.gov ID
- NCT02193425
- Acronym / sponsor ID
- 140144
- Conditions
- Normal Physiology
- Keywords
- fMRI, Brain Connectivity, PET, 18FDG
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)US National Institutes of Health
- Study start
- 8 Jun 2015 (actual)
- Primary completion
- 23 May 2023 (actual)
- Study completion
- 23 May 2023 (actual)
- First posted
- 17 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Pr(SqrRoot)(Copyright)cis:
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PET FDG & MRI Scans | Experimental | Drug: F-18FDG, Device: MRIThe test-retest reproducibility of the gender and aging effects on FC measures (lFCD, C, L and S) acquired in RS and TS conditions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Older than 18 years of age.
- 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
Key exclusion criteria (16 listed)
- 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.
- 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.
- 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.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| F-18FDG18F-Fluorodeoxyglucose (FDG)-PET session to assess the association between functional connectivity (FC) and glucose metabolism in the human brain. | Drug | PET FDG & MRI Scans |
| MRITwo MRI/MRS sessions to evaluate test-retest reliability of functional connectivity (FC) at rest as well as during task performance. | Device | PET FDG & MRI Scans |
Primary outcome
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.
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.
4 secondary outcomes
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
The association between IFCD and the underlying structural connectivity and its contribution to between- subjects FC-variability during RS.
Time frame: end of study
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: No. Data is analyzed in groups so no individual information will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dardo G Tomasi, Ph.D. principal investigator
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing F-18FDG and MRI in people with Normal Physiology, run by National Institute on Alcohol Abuse and Alcoholism (NIAAA) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: end of study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2026.