Back to resultsQuantitation of Glymphatic Functioning in Sleep and Meditative States
Primary Purpose
Parkinson Disease, Sleep
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Meditation
Sponsored by
About this trial
This is an interventional basic science trial for Parkinson Disease focused on measuring glymphatic system, meditation
Eligibility 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
Sites / Locations
- Vanderbilt University Medical CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Adept Meditators
Arm Description
Subjects will undergo scanning during awake, sleep deprived, and meditative states of consciousness.
Outcomes
Primary Outcome Measures
CSF flow change
Using MRI to assess the change in CSF flow in awake, sleep deprived, and meditative states
Secondary Outcome Measures
EEG changes
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.
Full Information
NCT ID
NCT04506892
First Posted
July 17, 2020
Last Updated
April 21, 2023
Sponsor
Vanderbilt University Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT04506892
Brief Title
Quantitation of Glymphatic Functioning in Sleep and Meditative States
Official Title
Quantitation of Glymphatic Functioning in Sleep and Meditative States
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2021 (Actual)
Primary Completion Date
July 2026 (Anticipated)
Study Completion Date
July 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University Medical Center
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
This study is evaluating the glymphatic system during awake, sleep, and meditative states.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease, Sleep
Keywords
glymphatic system, meditation
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Masking Description
no masking is used in this protocol
Allocation
N/A
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Adept Meditators
Arm Type
Experimental
Arm Description
Subjects will undergo scanning during awake, sleep deprived, and meditative states of consciousness.
Intervention Type
Behavioral
Intervention Name(s)
Meditation
Intervention Description
meditation
Primary Outcome Measure Information:
Title
CSF flow change
Description
Using MRI to assess the change in CSF flow in awake, sleep deprived, and meditative states
Time Frame
baseline to 24 hours
Secondary Outcome Measure Information:
Title
EEG changes
Description
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.
Time Frame
baseline to 24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Daniel Claassen, MD
Phone
6153226103
Email
daniel.claassen@vumc.org
First Name & Middle Initial & Last Name or Official Title & Degree
Maria Garza, MS
Email
maria.e.garza@vumc.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Claassen, MD
Organizational Affiliation
Vanderbilt University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37212-3160
Country
United States
Individual Site Status
Recruiting
12. IPD Sharing Statement
Learn more about this trial
Quantitation of Glymphatic Functioning in Sleep and Meditative States
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