NCT04506892

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P75+ for not_applicable parkinson-disease

Timeline
Completed

Started Feb 2021

Longer than P75 for not_applicable parkinson-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 17, 2020

Completed
24 days until next milestone

First Posted

Study publicly available on registry

August 10, 2020

Completed
6 months until next milestone

Study Start

First participant enrolled

February 1, 2021

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

August 6, 2025

Status Verified

August 1, 2025

Enrollment Period

3.8 years

First QC Date

July 17, 2020

Last Update Submit

August 1, 2025

Conditions

Keywords

glymphatic systemmeditation

Outcome Measures

Primary Outcomes (1)

  • CSF flow change

    Using MRI to assess the change in CSF flow in awake, sleep deprived, and meditative states

    baseline to 24 hours

Secondary Outcomes (1)

  • EEG changes

    baseline to 24 hours

Study Arms (1)

Adept Meditators

EXPERIMENTAL

Subjects will undergo scanning during awake, sleep deprived, and meditative states of consciousness.

Behavioral: Meditation

Interventions

MeditationBEHAVIORAL

meditation

Adept Meditators

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Ages 14-45
  • "Adept meditator status"

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37212-3160, United States

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

Meditation

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsSpiritual TherapiesRelaxation TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Daniel Claassen, MD

    Vanderbilt University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
no masking is used in this protocol
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

July 17, 2020

First Posted

August 10, 2020

Study Start

February 1, 2021

Primary Completion

December 1, 2024

Study Completion

December 1, 2024

Last Updated

August 6, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations