Use of a Functional Neuroimaging Battery for the Evaluation of a Meditation Retreat

NCT ID: NCT02443766

Last Updated: 2022-07-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

14 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-01-05

Study Completion Date

2017-03-02

Brief Summary

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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

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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

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Healthy

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Healthy Subjects

Healthy subjects will attend the weeklong meditation retreat.

Meditation Retreat

Intervention Type OTHER

Weeklong retreat which includes meditation and prayer.

Interventions

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Meditation Retreat

Weeklong retreat which includes meditation and prayer.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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).
* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Thomas Jefferson University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Andrew B. Newberg, MD

Role: PRINCIPAL_INVESTIGATOR

Thomas Jefferson University

Locations

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Thomas Jefferson University

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

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Other Identifiers

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11G.488

Identifier Type: -

Identifier Source: org_study_id

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