Parkinson DiseaseNCT04506892
Quantitation of Glymphatic Functioning in Sleep and Meditative States
A study testing Meditation in people with Parkinson Disease and Sleep, run by Vanderbilt University Medical Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease, Sleep
- What is being tested?
- Meditation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2021to 1 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Ages 14-45
- "Adept meditator status"
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37212-3160
About this study
This involves development and application of magnetic resonance imaging (MRI) methods for visualizing hemodynamic and metabolic relationships in healthy volunteers with advanced meditation experience.
Read the detailed description
This study is evaluating the glymphatic system during awake, sleep, and meditative states.
- Conditions
- Parkinson Disease, Sleep
- Being tested
- Meditation
- Keywords
- glymphatic system, meditation
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MeditationBehavioural
meditation
| Study group | Role | What they receive |
|---|---|---|
| Adept Meditators | Experimental | Subjects will undergo scanning during awake, sleep deprived, and meditative states of consciousness. Receives: Behavioral: Meditation |
What is being measured
The primary outcome is the main question the study is designed to answer.
CSF flow change
Using MRI to assess the change in CSF flow in awake, sleep deprived, and meditative states
Measured: baseline to 24 hours
Secondary outcomes (1)
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.
Measured: baseline to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2020
- Study start1 Feb 2021
- Primary completion1 Dec 2024
- Study completion1 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel Claassen, Vanderbilt University Medical Center
- Investigators
- Daniel Claassen, MD, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04506892
- Sponsor's protocol ID
- RFA-AT-21-001
- Status last verified
- Aug 2025
- First submitted
- 17 Jul 2020
- Last updated
- 6 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantitation of Glymphatic Functioning in Sleep and Meditative States
- ClinicalTrials.gov ID
- NCT04506892
- Acronym / sponsor ID
- RFA-AT-21-001
- Conditions
- Parkinson Disease, Sleep
- Keywords
- glymphatic system, meditation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 1 Dec 2024 (actual)
- Study completion
- 1 Dec 2024 (actual)
- First posted
- 10 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adept Meditators | Experimental | Behavioral: MeditationSubjects will undergo scanning during awake, sleep deprived, and meditative states of consciousness. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Ages 14-45
- "Adept meditator status"
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Meditationmeditation | Behavioural | Adept Meditators |
Primary outcome
CSF flow change
Time frame: baseline to 24 hours
Using MRI to assess the change in CSF flow in awake, sleep deprived, and meditative states
1 secondary outcome
EEG changes
Time frame: baseline to 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel Claassen, MD principal investigator
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Meditation in people with Parkinson Disease and Sleep, run by Vanderbilt University Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CSF flow change (time frame: baseline to 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2025.