Use of a Functional Neuroimaging Battery for the Evaluati... | NCT02443766

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

NCT02443766

Sponsor

Thomas Jefferson University

Status

Completed

Last Update Posted

Jul 25, 2022Actual

Enrollment

14Actual

Phase

Not provided

Conditions

Healthy

Interventions

Meditation Retreat

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Document Has No Statistical Analysis Plan (SAP)

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 5, 2012Actual

Primary Completion Date

Mar 2, 2017Actual

Completion Date

Mar 2, 2017Actual

First Submitted Date

Feb 6, 2015

First Submission Date that Met QC Criteria

May 11, 2015

First Posted Date

May 14, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 20, 2022

Last Update Posted Date

Jul 25, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

14Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Healthy Subjects		Healthy subjects will attend the weeklong meditation retreat.	Other: Meditation Retreat

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Meditation Retreat	Other	Weeklong retreat which includes meditation and prayer.	Healthy Subjects

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	Within one month of the retreat

Secondary Outcomes

Measure	Description	Time Frame
functional MRI	To detect changes in cerebral blood flow before and after a meditation retreat program.	Within one month of the retreat

Other Outcomes

Measure	Description	Time Frame
Speilberger State Trait Anxiety Inventory (STAI)	This validated questionnaire will be used as one of the evaluation questionnaires for the study. The Speilberger State Trait Anxiety Inventory (STAI) contains a total of 40 questions, half of which relate to the way subjects are feeling at the moment and half of which ask them to describe how they usually feel.	Within one month of the retreat

Eligibility Module

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder 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.

Sampling Method

Non-Probability Sample