Human Brain Mapping of the Apparent Diffusion Coefficient (ADC) During Sleep and Wakefulness

NCT02311374 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-05-22

No results posted yet for this study

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).

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.

Conditions

  • Brain Mapping

Interventions

OTHER

Brain connectivity and physiology

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.

OTHER

Brain Wave

ECG will be used to monitor heart rate variability (HRV), which differ significantly between the waking state and the different sleep stages

Sponsors & Collaborators

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

    lead NIH

Principal Investigators

  • Dardo G Tomasi, Ph.D. · National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-07-28
Primary Completion
2018-05-11
Completion
2018-05-11

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02311374 on ClinicalTrials.gov