Brain MappingEarly Phase 1NCT02311374
Human Brain Mapping of the Apparent Diffusion Coefficient (ADC) During Sleep and Wakefulness
A Early Phase 1 study testing Brain connectivity and physiology and Brain Wave in people with Brain Mapping, run by National Institute on Alcohol Abuse and Alcoholism (NIAAA) at 1 site in United States.
Trial summary
Background: The glymphatic system helps keep harmful waste from building up in the brain. Researchers think it is more active in people during sleep than while awake. They want to study the glymphatic system using magnetic resonance imaging (MRI). Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Brain Mapping
- What is being tested?
- Brain connectivity and physiology and Brain Wave
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jul 2015to 11 May 2018
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- All Participants
- Between 18 and 60 years of age as determined by self-report.
- Ability to provide written informed consent as determined by physical examination and verbal communication.
Who cannot join
- All Participants
- Subjects with self-report of insomnia as determined by self-report and/or medical history;
- Subjects with any of the following: narcolepsy, obstructive sleep apnea (OSA) and/or abnormal sleeping patterns (including but not limited to those who use a C-PAP machine, sleeping during the day, using medication to fall asleep, sleeps less than 6 hours per night, night shift workers), subjects reporting snoring as determined by self-report using STOP-BANG questionnaire for undiagnosed OSA (3 or more yes answers will exclude) and/or medical history;
- Subjects with a history of restless leg syndrome as determined by self-report and/or medical history;
- Use, in the past two weeks, of psychoactive medications (four weeks for fluoxetine) or medications that may affect brain function (including but not limited to opioid analgesics, tricyclic antidepressants, selective serotonin reuptake inhibitors [SSRIs], or serotonin norepinephrine reuptake inhibitors [SNRIs], benzodiazepines and barbiturates) as determined by self-report and/or medical history;
- 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.
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- Major medical problems that can impact brain function at the time of the scan (e.g., problems of the CNS including seizures and psychosis; cardiovascular disease including hypertension and arrhythmias; metabolic, autoimmune, endocrine disorders) as determined by self-report, medical history and/or clinical exam.
- Head trauma with loss of consciousness for more than 30 minutes as determined by self-report and/or medical history;
- Positive test for controlled substances (cocaine, methamphetamine, amphetamines, opioids, cannabinoids, benzodiazepines and barbiturates) on any day of study including upon check-in to NIH CC as determined by urine toxicology;
- Pregnant: Females must have negative urine pregnancy test
- Presence of ferromagnetic objects in the body that are contraindicated for MRI of the head (including but not limited to 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) or fear of enclosed spaces as determined by the self-report checklist.
- Fear of enclosed spaces (claustrophobia) as determined by self-report and medical history.
- Cannot lie comfortably flat on the back for up to 3 hours in the MRI scanner as determined by self-report.
- Body weight greater than 250 kg. This is the upper limit that the bed of the MR scanner can accommodate (clinical exam).
- Alcohol consumption on the day of the MRI as determined by breath alcohol test
- Study investigators and staff, as well as their superiors, subordinates and immediate family members (adult children, spouses, parents, siblings).
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
Background:
- The glymphatic system helps keep harmful waste from building up in the brain. Researchers think it is more active in people during sleep than while awake. They want to study the glymphatic system using magnetic resonance imaging (MRI).
Read more
Objective:
- To see if there are differences in the way waste is removed from the brain while a person is sleeping versus awake.
Eligibility:
- Healthy people age 18-60.
Design:
- This study is in 2 parts.
- For the technical part (discontinued), participants will be screened with medical history and physical exam. They will have urine and breath alcohol tests.
- Participants will have 2 MRI scans. Before the scans, they will have urine and breath alcohol tests, and complete a questionnaire.
- For MRI, participants will lie on a table that slides in and out of a metal cylinder. A device will be placed over their head. They will lie still for up to 20 minutes at a time. They may be asked to stay awake or fall asleep for up to 2 hours at a time.
- For the research part, participants will be screened with medical history and physical exam. They will have urine and breath alcohol tests. For 1 week they will wear a device that monitors their activity and sleep.
- Participants will stay at NIH overnight. They will give a blood sample, have urine and breath alcohol tests, and complete a questionnaire.
- Participants will take memory, concentration, and thinking tests.
- Participants will have 3 MRI scans. An electroencephalography machine will record their brain activity. Electrodes will be placed on their scalp.
Read the detailed description
OBJECTIVES:
The primary objectives are to assess if there is an increase in the apparent diffusion coefficient (ADC) in the human brain during sleep when compared to the awake state and to determine if they vary across brain regions. Secondary outcomes are to assess inter subject variability in the differences in ADC between awake and sleep. We will also run exploratory analysis to determine if ADC changes with sleep are associated with subjective perception of rested sleep and to assess if there are differences in T1 in CSF between the scan taken prior to falling asleep and those taken shortly after waking up.
STUDY POPULATION:
Healthy adults. Males and females will be included.
DESIGN:
Observational study with a technical phase and two research phases.
- The technical phase (discontinued) will recruit controls in order to define best MR parameters and pulse sequence to be used for optimal ADC signal detection for which we request permission to recruit up to 20 healthy volunteers. Technical Developmental Phase: Each participant will have a set of MRI scans at the following two times of day: the 1st between 11:00 AM and 1:00 PM (noon) and the second between 6:00 PM and 8:00 PM (evening).
- Research Phase I (complete testing in 10 healthy controls to assess effects on wake/sleep states on whole brain ADC) and research Phase II (complete testing in a total of 30 subjects to assess if there are regional differences) and to address the main and secondary outcomes proposed above. Only if we show that ADC significantly changes during sleep compared to awake state will we proceed to phase II. For phases I and II, the participants will spend 3 night in the clinical center and will undergo two MRI scan sessions following two fo the night stays to quantify brain ADC; once while awake (following a night of sleep) and the other while asleep (following a night of sleep deprivation). Scans for both days will be performed in the morning (between 9-12 PM). Electrocardiogram (ECG) will be recorded during all MRI scanning procedures to monitor sleep. For the first of the three nights we will simultaneously record the electroencephalogram (EEG) and ECG on the participants while they sleep which will allow us to correlate the ECG to their EEG signal, which is the gold standard for measuring sleep.
OUTCOME PARAMETERS:
ADCs and ECG will be measured at each time point for each study participant (pertinent to research phase only).
- Conditions
- Brain Mapping
- Being tested
- Brain connectivity and physiology, Brain Wave
- Keywords
- Human Brain, Sleep, EEG, Magnetic Resonance Imaging (MRI), Apparent Diffusion Coefficient (ADC)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brain connectivity and physiologyOther
Two MRI scanning session will be obtained for each participant both at the same time of day (9AM 12 PM). In one occasion they will be scanned after a night of rested sleep while awake and on another day they will be scanned after one night of sleep deprivation while sleeping in the scanner. In addition to the most sensitive technique selected in the development phase (either DWI or MT), each imaging MRI session will include (1) a resting-state functional connectivity (RSFC; 10 minutes) scan using single-shot T2*-weighted EPI; and (2) quantitative T1 relaxometry (T1) in a CSF voxel (1mL; cubic) using an inversion recovery experiment with increased interpulse intervals (TI = 200, 300, 400, 500, 700, 1000, 1500, 2000, 3000, 5000, 10000 ms) and a long TR (10000 ms; scan time 2 min) to assess the level of solutes in CSF.
Brain WaveOther
ECG will be used to monitor heart rate variability (HRV), which differ significantly between the waking state and the different sleep stages
| Study group | Role | What they receive |
|---|---|---|
| Phase 2 | Sham comparator | ADC will be measured in the same subject in the wake state (following a night of regular sleep) and during sleep (following a night of sleep deprivation). The MRI scans will be done in the morning (9-12 pm), once while the subject is sleeping (following a night of sleep deprivation) and once while awake (following regular sleep 9 AM-12 PM). Receives: Other: Brain connectivity and physiology; Other: Brain Wave |
| Phase I | Sham comparator | ADC will be measured in the same subject in the wake state (following a night of regular sleep) and during sleep (following a night of sleep deprivation). The MRI scans will be done in the morning (9 AM-12 pm), once while the subject is sleeping (following a night of sleep deprivation) and once while awake (following regular sleep 9 AM 12 PM). Receives: Other: Brain connectivity and physiology; Other: Brain Wave |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess if there is an increase in the apparent diffusion coefficient (ADC) in the human brain during sleep when compared to the awake state and to determine if they vary across brain regions.
To assess if there are differences between brain regions.
Measured: end of study
Secondary outcomes (1)
To assess inter subject variability in the differences in ADC between awake and sleep.
To determine if ADC differences are associated with subjective sense of rested sleep.
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 posted8 Dec 2014 (estimated)
- Study start28 Jul 2015
- Primary completion11 May 2018
- Study completion11 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain MappingStudies 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
- 40 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
- NCT02311374
- Sponsor's protocol ID
- 150031
- Other IDs
- 15-AA-0031
- Status last verified
- 28 May 2026
- First submitted
- 5 Dec 2014
- Last updated
- 8 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Analysis is done in groups not on an individual basis.
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
- Human Brain Mapping of the Apparent Diffusion Coefficient (ADC) During Sleep and Wakefulness
- ClinicalTrials.gov ID
- NCT02311374
- Acronym / sponsor ID
- 150031
- Conditions
- Brain Mapping
- Keywords
- Human Brain, Sleep, EEG, Magnetic Resonance Imaging (MRI), Apparent Diffusion Coefficient (ADC)
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)US National Institutes of Health
- Study start
- 28 Jul 2015 (actual)
- Primary completion
- 11 May 2018 (actual)
- Study completion
- 11 May 2018 (actual)
- First posted
- 8 Dec 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:
- The glymphatic system helps keep harmful waste from building up in the brain. Researchers think it is more active in people during sleep than while awake. They want to study the glymphatic system using magnetic resonance imaging (MRI).
Objective:
- To see if there are differences in the way waste is removed from the brain while a person is sleeping versus awake.
Eligibility:
- Healthy people age 18-60.
Design:
- This study is in 2 parts.
- For the technical part (discontinued), participants will be screened with medical history and physical exam. They will have urine and breath alcohol tests.
- Participants will have 2 MRI scans. Before the scans, they will have urine and breath alcohol tests, and complete a questionnaire.
- For MRI, participants will lie on a table that slides in and out of a metal cylinder. A device will be placed over their head. They will lie still for up to 20 minutes at a time. They may be asked to stay awake or fall asleep for up to 2 hours at a time.
- For the research part, participants will be screened with medical history and physical exam. They will have urine and breath alcohol tests. For 1 week they will wear a device that monitors their activity and sleep.
- Participants will stay at NIH overnight. They will give a blood sample, have urine and breath alcohol tests, and complete a questionnaire.
- Participants will take memory, concentration, and thinking tests.
- Participants will have 3 MRI scans. An electroencephalography machine will record their brain activity. Electrodes will be placed on their scalp.
Detailed description
OBJECTIVES:
The primary objectives are to assess if there is an increase in the apparent diffusion coefficient (ADC) in the human brain during sleep when compared to the awake state and to determine if they vary across brain regions. Secondary outcomes are to assess inter subject variability in the differences in ADC between awake and sleep. We will also run exploratory analysis to determine if ADC changes with sleep are associated with subjective perception of rested sleep and to assess if there are differences in T1 in CSF between the scan taken prior to falling asleep and those taken shortly after waking up.
STUDY POPULATION:
Healthy adults. Males and females will be included.
DESIGN:
Observational study with a technical phase and two research phases.
- The technical phase (discontinued) will recruit controls in order to define best MR parameters and pulse sequence to be used for optimal ADC signal detection for which we request permission to recruit up to 20 healthy volunteers. Technical Developmental Phase: Each participant will have a set of MRI scans at the following two times of day: the 1st between 11:00 AM and 1:00 PM (noon) and the second between 6:00 PM and 8:00 PM (evening).
- Research Phase I (complete testing in 10 healthy controls to assess effects on wake/sleep states on whole brain ADC) and research Phase II (complete testing in a total of 30 subjects to assess if there are regional differences) and to address the main and secondary outcomes proposed above. Only if we show that ADC significantly changes during sleep compared to awake state will we proceed to phase II. For phases I and II, the participants will spend 3 night in the clinical center and will undergo two MRI scan sessions following two fo the night stays to quantify brain ADC; once while awake (following a night of sleep) and the other while asleep (following a night of sleep deprivation). Scans for both days will be performed in the morning (between 9-12 PM). Electrocardiogram (ECG) will be recorded during all MRI scanning procedures to monitor sleep. For the first of the three nights we will simultaneously record the electroencephalogram (EEG) and ECG on the participants while they sleep which will allow us to correlate the ECG to their EEG signal, which is the gold standard for measuring sleep.
OUTCOME PARAMETERS:
ADCs and ECG will be measured at each time point for each study participant (pertinent to research phase only).
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phase 2 | Sham comparator | Other: Brain connectivity and physiology, Other: Brain WaveADC will be measured in the same subject in the wake state (following a night of regular sleep) and during sleep (following a night of sleep deprivation). The MRI scans will be done in the morning (9-12 pm), once while the subject is sleeping (following a night of sleep deprivation) and once while awake (following regular sleep 9 AM-12 PM). |
| Phase I | Sham comparator | Other: Brain connectivity and physiology, Other: Brain WaveADC will be measured in the same subject in the wake state (following a night of regular sleep) and during sleep (following a night of sleep deprivation). The MRI scans will be done in the morning (9 AM-12 pm), once while the subject is sleeping (following a night of sleep deprivation) and once while awake (following regular sleep 9 AM 12 PM). |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- All Participants
- Between 18 and 60 years of age as determined by self-report.
- Ability to provide written informed consent as determined by physical examination and verbal communication.
Key exclusion criteria (16 listed)
- All Participants
- Subjects with self-report of insomnia as determined by self-report and/or medical history;
- Subjects with any of the following: narcolepsy, obstructive sleep apnea (OSA) and/or abnormal sleeping patterns (including but not limited to those who use a C-PAP machine, sleeping during the day, using medication to fall asleep, sleeps less than 6 hours per night, night shift workers), subjects reporting snoring as determined by self-report using STOP-BANG questionnaire for undiagnosed OSA (3 or more yes answers will exclude) and/or medical history;
- Subjects with a history of restless leg syndrome as determined by self-report and/or medical history;
- Use, in the past two weeks, of psychoactive medications (four weeks for fluoxetine) or medications that may affect brain function (including but not limited to opioid analgesics, tricyclic antidepressants, selective serotonin reuptake inhibitors [SSRIs], or serotonin norepinephrine reuptake inhibitors [SNRIs], benzodiazepines and barbiturates) as determined by self-report and/or medical history;
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 |
|---|---|---|
| Brain connectivity and physiologyTwo MRI scanning session will be obtained for each participant both at the same time of day (9AM 12 PM). In one occasion they will be scanned after a night of rested sleep while awake and on another day they will be scanned after one night of sleep deprivation while sleeping in the scanner. In addition to the most sensitive technique selected in the development phase (either DWI or MT), each imaging MRI session will include (1) a resting-state functional connectivity (RSFC; 10 minutes) scan using single-shot T2*-weighted EPI; and (2) quantitative T1 relaxometry (T1) in a CSF voxel (1mL; cubic) using an inversion recovery experiment with increased interpulse intervals (TI = 200, 300, 400, 500, 700, 1000, 1500, 2000, 3000, 5000, 10000 ms) and a long TR (10000 ms; scan time 2 min) to assess the level of solutes in CSF. | Other | Phase 2, Phase I |
| Brain WaveECG will be used to monitor heart rate variability (HRV), which differ significantly between the waking state and the different sleep stages | Other | Phase 2, Phase I |
Primary outcome
To assess if there is an increase in the apparent diffusion coefficient (ADC) in the human brain during sleep when compared to the awake state and to determine if they vary across brain regions.
Time frame: end of study
To assess if there are differences between brain regions.
1 secondary outcome
To assess inter subject variability in the differences in ADC between awake and sleep.
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. Analysis is done in groups not on an individual basis.
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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 Brain connectivity and physiology and Brain Wave in people with Brain Mapping, 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. Some participants in this study may receive a placebo. 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?
To assess if there is an increase in the apparent diffusion coefficient (ADC) in the human brain during sleep when compared to the awake state and to determine if they vary across brain regions. (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.