Quantitation of Glymphatic Functioning in Sleep and Meditative States

Parkinson Disease Clinical Trial

Official title:

Quantitation of Glymphatic Functioning in Sleep and Meditative States

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04506892
• Other study ID #: RFA-AT-21-001
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2021
• Est. completion date: July 2027

Study information

• Verified date: April 2024
• Source: Vanderbilt University Medical Center
• Contact: Daniel Claassen, MD
• Phone: 6153226103
• Email: daniel.claassen[@]vumc.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: July 2027
• Est. primary completion date: July 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease
• Sleep

Intervention

Behavioral:
• Meditation
meditation

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CSF flow change	Using MRI to assess the change in CSF flow in awake, sleep deprived, and meditative states	baseline to 24 hours
Secondary	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.	baseline to 24 hours