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Quantitation of Glymphatic Functioning in Sleep and Meditative States

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04506892
Recruitment Status : Recruiting
First Posted : August 10, 2020
Last Update Posted : April 22, 2022
Sponsor:
Information provided by (Responsible Party):
Daniel Claassen, Vanderbilt University Medical Center

Study Description
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Brief Summary:
This involves development and application of magnetic resonance imaging (MRI) methods for visualizing hemodynamic and metabolic relationships in healthy volunteers with advanced meditation experience.

Condition or disease Intervention/treatment Phase
Parkinson Disease Sleep Behavioral: Meditation Not Applicable

Detailed Description:
This study is evaluating the glymphatic system during awake, sleep, and meditative states.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Masking Description: no masking is used in this protocol
Primary Purpose: Basic Science
Official Title: Quantitation of Glymphatic Functioning in Sleep and Meditative States
Actual Study Start Date : February 1, 2021
Estimated Primary Completion Date : July 2026
Estimated Study Completion Date : July 2027

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Adept Meditators
Subjects will undergo scanning during awake, sleep deprived, and meditative states of consciousness.
 Behavioral: Meditation
meditation


Outcome Measures
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Primary Outcome Measures :
  1. CSF flow change [ Time Frame: baseline to 24 hours ]
    Using MRI to assess the change in CSF flow in awake, sleep deprived, and meditative states


Secondary Outcome Measures :
  1. EEG changes [ Time Frame: baseline to 24 hours ]
    Looking at brain wave changes before and after intervention in Alpha, Beta, and Delta waves associated with light to deep sleep. The lowest bandwidth for alpha waves is 8 while the highest is 12. The lowest bandwidth for Beta waves is 13 Hz while the highest is 30 Hz. The lowest bandwidth for Delta waves is .4 Hz and the highest is 4 Hz.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Ages 14-45
  • "Adept meditator status"

Exclusion Criteria:

  • Any non-MR compatible material implant, or contraindication to MR scanning
  • Claustrophobia or inability to lie still for prolonged periods of time
  • Participants with a recent (less than 2 months) infection, tattoo, or wound
  • No consumption of stimulants or alcohol within 12 hours of the study visit
  • clinical diagnosis of any major neurological or psychological condition
  • Taking benzodiazepines, cholinestorase inhibitors, anti-psychotics, opioids, MAO inhibitors
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04506892


Contacts
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Contact: Daniel Claassen, MD 6153226103 daniel.claassen@vumc.org
Contact: Maria Garza, MS maria.e.garza@vumc.org

Locations
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United States, Tennessee
Vanderbilt University Medical Center Recruiting
Nashville, Tennessee, United States, 37212-3160
Sponsors and Collaborators
Vanderbilt University Medical Center
Investigators
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Principal Investigator: Daniel Claassen, MD Vanderbilt University Medical Center
More Information
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Responsible Party: Daniel Claassen, Associate Professor, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT04506892    
Other Study ID Numbers: RFA-AT-21-001
First Posted: August 10, 2020    Key Record Dates
Last Update Posted: April 22, 2022
Last Verified: April 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Daniel Claassen, Vanderbilt University Medical Center:
glymphatic system
meditation
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Movement Disorders
Synucleinopathies
Neurodegenerative Diseases