Clinical trial NCT02443766: Use of a Functional Neuroimaging Battery for the Evaluation of a Meditation Retreat
Official title: Use of a Functional Neuroimaging Battery for the Evaluation of a Meditation
Study type: OBSERVATIONAL
Overall status: COMPLETED
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
General Health
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
First posted: 2015-05-14
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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. 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Single Photon Emission Computed Tomography (SPECT) Imaging (DaTScan)
timeFrame: Within one month of the retreat
Secondary outcomes:
measure: functional MRI
timeFrame: Within one month of the retreat
Other outcomes:
measure: Speilberger State Trait Anxiety Inventory (STAI)
timeFrame: Within one month of the retreat
measure: Profile of Moods Scale (POMS)
timeFrame: Within one month of the retreat
measure: Beck Depression Inventory (Beck 1972)
timeFrame: Within one month of the retreat
measure: Standard Form-12 (SF-12)
timeFrame: Within one month of the retreat
measure: Hood Mysticism Scale (Lifetime)
timeFrame: Within one month of the retreat
measure: Brief Multidimensional Measure of Religiousness/Spirituality
timeFrame: Within one month of the retreat
measure: Gratitude Questionnaire
timeFrame: Within one month of the retreat
measure: Daily Spiritual Experience Scale
timeFrame: Within one month of the retreat
measure: The Assessment of Spirituality and Religious Sentiments (ASPIRES )
timeFrame: Within one month of the retreat
measure: Index of Core Spiritual Experiences (INSPIRIT)
timeFrame: Within one month of the retreat
measure: Functional Assessment of Chronic Illness Therapy Spiritual Well-Being (FACIT-Sp-12)
timeFrame: Within one month of the retreat
measure: Cloninger Self-Transcendence Scale
timeFrame: Within one month of the retreat
measure: Five Facet Mindfulness Questionnaire
timeFrame: Within one month of the retreat
Locations:
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
Study officials:
affiliation: Thomas Jefferson University
name: Andrew B. Newberg, MD
role: PRINCIPAL_INVESTIGATOR
References: