MRI of Glymphatic Clearance During Anesthetic Sedation

January 23, 2018 updated by: University of Pennsylvania

Glymphatic Clearance During Anesthesia and Sleep: A Diffusion Tensor Imaging (DTI) Study in Humans

This study is to assess the effect of dexmedetomidine anesthesia on glymphatic flow in 5 healthy human subjects as visualized by diffusion tensor MRI. The study is designed to measure clinically established, safe imaging of DTI and cerebral blood flow at baseline, during a continuous intravenous infusion of dexmedetomidine at doses designed to produce anesthesia-induced unconsciousness to simulate natural sleep, and again on return to wakefulness.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Objective:

The purpose of this study is to assess the effect of dexmedetomidine anesthesia on glymphatic flow in human subjects as visualized by diffusion tensor MRI.

Study Design:

This study will take place at the University of Pennsylvania. Investigators plan to enroll approximately 30 healthy volunteers to generate pilot data for a larger grant submission.

Characteristics of the Study Population:

Subjects will be healthy males or females aged 20 to 40 years of age who will be recruited to participate in an MRI scan designed to measure clinically established, safe imaging of diffusion tensor imaging and cerebral blood flow at baseline, during a continuous intravenous infusion of dexmedetomidine at doses designed to produce anesthesia-induced unconsciousness to simulate natural sleep, and again on return to wakefulness. They must be able to pass the standard MRI safety assessment (e.g., no metallic metal clips or implants or any other contraindications to undergoing an MRI).

Design:

Upon successful completion of screening questionnaire, urine drug, and urine pregnancy subjects will be scheduled for an MRI. On the day of the study subjects will receive an intravenous catheter (IV) for study drug and fluids. Set one of MRI scans will be done with no dexmedetomidine. Set two of scans will be done when subject is anesthetized with dexmedetomidine with the goal depth of sedation will be moderate sedation. Set three of scans will be done when dexmedetomidine is stopped and wakefulness is achieved.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
17

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Person aged 20-40 years old,
  2. American Society of Anesthesiologists Physical Status I or II (i.e., healthy),
  3. Body mass index ≤ 30 kg/m2,
  4. Easily visualized uvula,
  5. Not a current tobacco user
  6. No history of alcohol abuse/must abstain from alcohol use 24 hours prior to and 24 hours after participation.
  7. Ability to sign informed consent.
  8. Able to pass standard MRI safety screening
  9. Must have a responsible adult available to transport subject home safely after end of experiment.

Exclusion Criteria:

  1. Healthy male or females less than 20 years of age or older than 40 years of age
  2. Any physical signs suggestive of difficult airway (mouth opening 3cm, short distance between the chin and neck, poor mandibular subluxation, thick neck),
  3. History of obstructive sleep apnea,
  4. History of asthma
  5. Neuropsychiatric disorders,
  6. History of, or current use of psychotropic medications,
  7. Current tobacco use or history of smoking in past month
  8. Alcohol use exceeding 2 drinks/day
  9. History of hypertension or current medication for blood pressure control,
  10. Cardiovascular disease or arrhythmias,
  11. Positive urine toxicology screen,
  12. History of gastroesophageal reflux disease,
  13. Pregnancy,
  14. Sleep disorders,
  15. History of postoperative nausea/vomiting or motion sickness,
  16. Inability to sign informed consent
  17. Contraindications for safely participating in MRI imaging study,
  18. Does not have a responsible adult available to provide transport from HUP MRI area to home.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Brain connectivity and physiology
Dexmedetomidine anesthesia on glymphatic flow in human subjects as visualized by diffusion tensor MRI.
Other: Brain connectivity and physiology
MRI to measure glymphactic flow during simulated natural sleep and again on return to wakefulness.
Drug: Dexmedetomidine
Administering of 0.5-1.0 mcg/kg/hr of dexmedetomidine to ensure subject's loss of consciousness.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Glymphatic clearance from the human brain
Time Frame: 2 hours
Assessment of the effect of dexmedetomidine anesthesia on glymphatic flow in subjects as visualized by diffusion tensor MRI.
2 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Pennsylvania

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Max B Kelz, MD, Physician

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 9, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 5, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 10, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 11, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 25, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 23, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 819962

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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