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

Brain Mapping Clinical Trial

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

Status Completed

Clinical 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).

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.

Clinical Trial 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). ;

Related Conditions & MeSH terms

• Brain Mapping

• NCT number: NCT02311374
• Study type: Interventional
• Source: National Institutes of Health Clinical Center (CC)
• Status: Completed
• Phase: Early Phase 1
• Start date: July 28, 2015
• Completion date: May 11, 2018