HealthyFETZERNCT02443766
Use of a Functional Neuroimaging Battery for the Evaluation of a Meditation Retreat
An observational study of Healthy, run by Thomas Jefferson University at 1 site in United States.
Trial summary
Over 2 decades scientists have been studying the effect on brain function from meditation practices. The purpose of this study is to measure the effect of a meditation retreat program on serotonin and dopamine transporter binding and changes in cerebral blood flow. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Meditation Retreat
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jan 2012to 2 Mar 2017
- Phase
- Observational
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: At present, study participants are recruited from a variety of meditation programs and through the Center of Integrative Medicine. All subjects will be healthy adults.
Who may be able to join
- Able to give informed consent and willing to complete the study.
- Willing to undergo the full imaging procedures.
- Women of childbearing potential with a negative serum pregnancy test.
Who cannot join
- Any neurological or psychiatric disorders, including drug or alcohol abuse, that may interfere with cerebral blood flow as determined by the principal investigator.
- Any medical conditions that may interfere with cerebral blood flow as determined by the principal investigator.
- Currently taking medication that might affect cerebral blood flow (i.e. antidepressants, antipsychotics, anxiolytics, benzodiazepines, sedatives, antiseizure medications)
- Subject is unable or unwilling to lie still in the scanner (i.e. due to claustrophobia or weight > 350 pounds)
- Subject has metal in their body or other reason that they cannot undergo magnetic resonance imaging.
- Previous brain surgery or intracranial abnormalities they may complicate interpretation of the brain scans. (e.g. stroke, tumor, vascular abnormality).
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- Pregnancy
- Allergy to iodine or shellfish.
- Concurrent participation in another research protocol that might affect the outcome of this study as determined by the principle Investigator.
Trial locations and contacts
1 site in 1 country.
United States1 site
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
About this study
Official title: Use of a Functional Neuroimaging Battery for the Evaluation of a Meditation
Over 2 decades scientists have been studying the effect on brain function from meditation practices. The purpose of this study is to measure the effect of a meditation retreat program on serotonin and dopamine transporter binding and changes in cerebral blood flow. The retreat program that will be followed is a week-long retreat called the Ignatian Retreat.
Read the detailed description
This study will utilize DaTscan single photon emission computed tomography (SPECT) and functional magnetic resonance imaging (fMRI) in healthy subjects within one month of entering the retreat. The study uses DaTscan to measure the effect on serotonin and dopamine transporter binding, and functional magnetic resonance imaging (fMRI) to measure the effect on cerebral blood flow. The Ignatian Retreat is a weeklong retreat which involves meditation and prayer.
Additionally, study participants will complete a variety of questionnaires and scales to measure psychological and spirituality states. The scans and questionnaires will be completed before and after the participant has completed the retreat. The ultimate goal of the study is to analyze and compare pre and post imaging and neuropsychological and spirituality changes in healthy controls who participate in this retreat.
- Conditions
- Healthy
- Being tested
- Meditation Retreat
- Keywords
- Integrative Medicine, Alternative Medicine, Complementary Medicine, Meditation Retreat, Ignatian Retreat, Single Photon Emission Computed Tomography (SPECT), Functional Magnetic Resonance Imaging (fMRI), Wellbeing, General Health
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Meditation RetreatOther
Weeklong retreat which includes meditation and prayer.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Subjects | Healthy subjects will attend the weeklong meditation retreat. Receives: Other: Meditation Retreat |
What is being measured
The primary outcome is the main question the study is designed to answer.
Single Photon Emission Computed Tomography (SPECT) Imaging (DaTScan)
To detect changes in dopamine and serotonin before and after a meditation retreat program in serotonin transporter and dopamine transporter binding.
Measured: Within one month of the retreat
Secondary outcomes (1)
functional MRI
To detect changes in cerebral blood flow before and after a meditation retreat program.
Measured: Within one month of the retreat
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2015 (estimated)
- Study start5 Jan 2012
- Primary completion2 Mar 2017
- Study completion2 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Thomas Jefferson UniversityThe 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrew B. Newberg, MD, Principal investigator, Thomas Jefferson University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02443766
- Sponsor's protocol ID
- 11G.488
- Acronym
- FETZER
- Status last verified
- Jul 2022
- First submitted
- 6 Feb 2015
- Last updated
- 25 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of a Functional Neuroimaging Battery for the Evaluation of a Meditation
- ClinicalTrials.gov ID
- NCT02443766
- Acronym / sponsor ID
- FETZER / 11G.488
- Conditions
- Healthy
- Keywords
- Integrative Medicine, Alternative Medicine, Complementary Medicine, Meditation Retreat, Ignatian Retreat, Single Photon Emission Computed Tomography (SPECT), Functional Magnetic Resonance Imaging (fMRI), Wellbeing
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Thomas Jefferson UniversityUniversity, hospital or other
- Study start
- 5 Jan 2012 (actual)
- Primary completion
- 2 Mar 2017 (actual)
- Study completion
- 2 Mar 2017 (actual)
- First posted
- 14 May 2015 (estimated)
- 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.
Over 2 decades scientists have been studying the effect on brain function from meditation practices. The purpose of this study is to measure the effect of a meditation retreat program on serotonin and dopamine transporter binding and changes in cerebral blood flow. The retreat program that will be followed is a week-long retreat called the Ignatian Retreat.
Detailed description
This study will utilize DaTscan single photon emission computed tomography (SPECT) and functional magnetic resonance imaging (fMRI) in healthy subjects within one month of entering the retreat. The study uses DaTscan to measure the effect on serotonin and dopamine transporter binding, and functional magnetic resonance imaging (fMRI) to measure the effect on cerebral blood flow. The Ignatian Retreat is a weeklong retreat which involves meditation and prayer.
Additionally, study participants will complete a variety of questionnaires and scales to measure psychological and spirituality states. The scans and questionnaires will be completed before and after the participant has completed the retreat. The ultimate goal of the study is to analyze and compare pre and post imaging and neuropsychological and spirituality changes in healthy controls who participate in this retreat.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy Subjects | – | Other: Meditation RetreatHealthy subjects will attend the weeklong meditation retreat. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- At present, study participants are recruited from a variety of meditation programs and through the Center of Integrative Medicine. All subjects will be healthy adults.
Key inclusion criteria (3 listed)
- Able to give informed consent and willing to complete the study.
- Willing to undergo the full imaging procedures.
- Women of childbearing potential with a negative serum pregnancy test.
Key exclusion criteria (9 listed)
- Any neurological or psychiatric disorders, including drug or alcohol abuse, that may interfere with cerebral blood flow as determined by the principal investigator.
- Any medical conditions that may interfere with cerebral blood flow as determined by the principal investigator.
- Currently taking medication that might affect cerebral blood flow (i.e. antidepressants, antipsychotics, anxiolytics, benzodiazepines, sedatives, antiseizure medications)
- Subject is unable or unwilling to lie still in the scanner (i.e. due to claustrophobia or weight > 350 pounds)
- Subject has metal in their body or other reason that they cannot undergo magnetic resonance imaging.
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 |
|---|---|---|
| Meditation RetreatWeeklong retreat which includes meditation and prayer. | Other | Healthy Subjects |
Primary outcome
Single Photon Emission Computed Tomography (SPECT) Imaging (DaTScan)
Time frame: Within one month of the retreat
To detect changes in dopamine and serotonin before and after a meditation retreat program in serotonin transporter and dopamine transporter binding.
1 secondary outcome
functional MRI
Time frame: Within one month of the retreat
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 25 Jul 2022.
- Publication from study resultsLink provided by the sponsor.
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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.
Andrew B. Newberg, MD principal investigator
Thomas Jefferson University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by Thomas Jefferson University 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 3 inclusion and 9 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 25 Jul 2022. 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?
Single Photon Emission Computed Tomography (SPECT) Imaging (DaTScan) (time frame: Within one month of the retreat). 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 25 Jul 2022.