Evaluating Multivariate MRI Maps of Body Awareness (EMBODY)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03344081|
Recruitment Status : Recruiting
First Posted : November 17, 2017
Last Update Posted : December 6, 2018
|Condition or disease|
The investigators are developing a new functional magnetic resonance imaging (fMRI) task (the EMBODY Task) to measure mental states during meditation using pattern recognition or machine learning technology. This task is being piloted and validated in 20 meditators and 20 control participants, in two waves of pilot testing. Meditators will have practiced meditation for at least the 5 years, at least 90 minutes weekly. Control participants will have little to no meditation experience and will be age- and gender-matched to each meditator. All participants will be MRI-compatible, healthy with no health conditions that affect breathing, have no current psychiatric disorder, and not be taking psychotropic medications.
In the EMBODY Task, participants will be instructed to pay attention to areas of the body, their thoughts, sounds in the scanner, and to stop paying attention, in short intervals (16-45s). They will also meditate on their breath for 10 minutes. The investigators will determine whether pattern recognition technology can distinguish 5 mental states, and whether these brain patterns can be used to identify mental states during meditation. The investigators hypothesize that all 5 mental states will be distinguished by pattern recognition in the meditators, and potentially in the controls. Investigators also hypothesize that meditators should pay attention to their breath longer during meditation compared to controls.
|Study Type :||Observational|
|Estimated Enrollment :||20 participants|
|Official Title:||Evaluating Multivariate MRI Maps of Body Awareness: A Pilot Functional Magnetic Resonance Imaging (fMRI) Study of Breath Meditation|
|Actual Study Start Date :||June 1, 2016|
|Estimated Primary Completion Date :||January 31, 2021|
|Estimated Study Completion Date :||January 31, 2021|
Meditators will have practiced meditation for at least the 5 years, at least 90 minutes weekly. They will have completed at least 14 days of retreat practice in the past 5 years. At least half of their meditation practice will include attention to the breath and body. All participants will be MRI-compatible, healthy with no health conditions that affect breathing, have no current psychiatric disorder, and not be taking psychotropic medications.
Control participants will be age- and gender-matched to each meditators. They will have little to no previous meditation experience. All participants will be MRI-compatible, healthy with no health conditions that affect breathing, have no current psychiatric disorder, and not be taking psychotropic medications.
- Classification accuracy of brain patterns from EMBODY Task [ Time Frame: Outcome measure will be assessed once at the baseline fMRI scan to develop the pilot fMRI task. ]The EMBODY Task is a new brain-based measure using functional magnetic resonance imaging (fMRI) to measure meditation skills. The primary outcome measure of the EMBODY Task is whether brain patterns are recognized by pattern classification algorithms for the 5 conditions in the study (attention to breath, body, mind wandering, thoughts, and sounds) above chance levels (20% for 5 conditions, using a one-sample t-test for each condition in the entire sample). Classification accuracy is a standard outcome measure in studies that use brain pattern classification. This will demonstrate that brain patterns associated with internal attention are indeed differentiable by pattern classification methods. These brain patterns will then be used to identify the focus of attention during breath meditation.
- Percentage time paying attention to breath during meditation [ Time Frame: Outcome measure will be assessed once at the baseline fMRI scan to develop the pilot fMRI task. ]Using EMBODY Task metrics, investigators will calculate how much time people pay attention to their breath during meditation
- Percentage time spent mind wandering during meditation [ Time Frame: Outcome measure will be assessed once at the baseline fMRI scan to develop the pilot fMRI task. ]Using EMBODY Task metrics, investigators will calculate how much time people were mind wandering during meditation
- Questionnaire measures of attention [ Time Frame: Measures will be assessed before the fMRI scan session. ]To validate the EMBODY Task, investigators will administer self-report measures of attention, mindfulness, and body awareness
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03344081
|Contact: Helen Y Weng, PhD||415-514-8445||Helen.Weng@ucsf.edu|
|United States, California|
|Osher Center for Integrative Medicine||Recruiting|
|San Francisco, California, United States, 94117|
|Contact: Helen Y Weng, PhD 415-514-8445 Helen.Weng@ucsf.edu|
|Principal Investigator:||Helen Y Weng, PhD||University of California, San Francisco|