Quantitation of Glymphatic Functioning in Sleep and Meditative States

• Sponsor: Vanderbilt University Medical Center (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04506892
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 76.9
• Patients Per Site Per Month: 0.5

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Parkinson Disease; Sleep	Behavioral: Meditation	N/A

Detailed Description

This study is evaluating the glymphatic system during awake, sleep, and meditative states.

Study Design

• Study Type: Interventional
• Anticipated 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: Feb 1, 2021
• Anticipated Primary Completion Date: Jul 1, 2026
• Anticipated Study Completion Date: Jul 1, 2027

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. CSF flow change [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 [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

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	Vanderbilt University Medical Center	Nashville	Tennessee	United States	37212-3160

Sponsors and Collaborators

• Vanderbilt University Medical Center

Investigators

• Principal Investigator: Daniel Claassen, MD, Vanderbilt University Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Daniel Claassen, Associate Professor, Vanderbilt University Medical Center
• ClinicalTrials.gov Identifier: NCT04506892
• Other Study ID Numbers: RFA-AT-21-001
• First Posted: Aug 10, 2020
• Last Update Posted: Apr 22, 2022
• Last Verified: Apr 1, 2022

• 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, Associate Professor, Vanderbilt University Medical Center: glymphatic system; meditation
• Additional relevant MeSH terms: Parkinson Disease

Study Results

No Results Posted as of Apr 22, 2022