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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 : Not yet recruiting
First Posted : August 10, 2020
Last Update Posted : August 10, 2020
Sponsor:
Information provided by (Responsible Party):
Daniel Claassen, Vanderbilt University Medical Center

Brief Summary:
This involves development and application of magnetic resonance imaging (MRI) methods for visualizing hemodynamic and metabolic relationships in healthy volunteers, and patient volunteers diagnosed with Parkinson's disease (PD) through use of a guided meditation intervention.

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

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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)
Primary Purpose: Supportive Care
Official Title: Quantitation of Glymphatic Functioning in Sleep and Meditative States
Estimated Study Start Date : July 2021
Estimated Primary Completion Date : July 2026
Estimated Study Completion Date : July 2027

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Meditation Class
Subjects will undergo an intervention involving meditation classes for 2.5 hours a week for 8 weeks between pre- and post-class MRI
Behavioral: Meditation
Meditation classes will help to improve clinical health and well-being, as well as reduce stress.




Primary Outcome Measures :
  1. CSF flow change [ Time Frame: baseline to 8 weeks ]
    Using MRI to assess the change in CSF flow before and after intervention


Secondary Outcome Measures :
  1. EEG changes [ Time Frame: baseline to 8 weeks ]
    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.

  2. Hospital Anxiety and Depression Scale [ Time Frame: baseline to 8 weeks ]
    Looking at behavioral correlates (i.e. anxiety, depression) associated with before and after intervention. There are 2 parts, Anxiety, where the lowest score would be a 0 and the highest is 21, and the higher a score is, the more anxious behaviors there are. The second part is a depressive behavior scale, which the lowest score is 0, and the highest is 21, and the higher the score, the more depressive behaviors there are.



Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Ages 60-80
  • Parkinson's Disease diagnosis or healthy
  • able to take part in a meditation based intensive class for 8 weeks once a week

Exclusion Criteria:

  • DBS or any non-MR compatible metal
  • any other neurological diseases that do not indicate Parkinson's Disease
  • any other cognitive impairments greater than a mild cognitive impairment

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: Ciaran Considine, PhD ciaran.considine@vumc.org

Locations
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United States, Tennessee
Vanderbilt University Medical Center
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
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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: August 10, 2020
Last Verified: August 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: 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
Neurodegenerative Diseases