- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03344081
Evaluating Multivariate MRI Maps of Body Awareness (EMBODY)
Evaluating Multivariate MRI Maps of Body Awareness: A Pilot Functional Magnetic Resonance Imaging (fMRI) Study of Breath Meditation
Study Overview
Status
Conditions
Detailed Description
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
Enrollment (Actual)
Contacts and Locations
Study Locations
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California
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San Francisco, California, United States, 94117
- Osher Center for Integrative Medicine
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Healthy adults, 25-65 years of age.
- Meditators will be affiliated with meditation centers that are based in the Vipassana tradition or Zen traditions. In the past 5 years, meditators will have a consistent practice in mindfulness of body practices, where consistent practice is defined as practicing for at least 90 minutes in a typical week. They will also have had at least 14 days of total silent retreat practice in the past 5 years. At least half of total practice time as reported by the participants will be engaged in mindfulness of body practices (e.g., breath meditation, body scan, mindfulness of emotions, mindful yoga, walking meditation).
- Non-meditator control group. Within the past 3 years, participants will not have engaged in regular meditation (including from courses such as Mindfulness-Based Stress Reduction, Mindfulness-Based Cognitive Therapy, and Dialectical Behavioral Therapy), yoga, or other mind-body practice (such as Tai Chi, Feldenkrais, sensory awareness, or related practices), defined as more than 20 minutes of practice at least two times per week. If there is experience with mind-body practices prior to the past 3 years, it should not include an extended period of consistent practice (such as 20 min daily practice for a year or more) or a period of intensive practice longer than 7 days (e.g., 10-day silent retreat).
Exclusion Criteria:
Participants who endorse:
- being smokers;
- chronic or recurrent bronchial or pulmonary disease requiring medical attention;
- having been diagnosed with sleep apnea;
- a history of an upper or lower respiratory tract infection in the 6 weeks preceding the study;
- pregnancy;
- diseases that restrain chest or abdominal breathing, such as ankylosing spondylitis, systemic lupus, chronic abdominal pain, chronic liver or kidney diseases,
- can not fit comfortably in the MRI scanner.
- potentially confounding medical conditions that impact breathing (e.g.,asthma, congestive heart failure, and emphysema that are not well-controlled), could impact attention to the breath (e.g., chronic pain conditions that are not well-managed), or impact neural functioning (e.g., multiple sclerosis, neurological diseases, brain injury);
- currently experiencing a mental health condition (e.g., anxiety, depression, panic disorder, post-traumatic stress disorder, attention deficit and hyperactivity disorder) or past severe mental illness such as bipolar disorder, schizophrenia, or severe substance abuse disorder.
- use of psychotropic medications in the past year
- current use of medications that potentially can affect the respiratory system or the interoceptive focus in the past week (including narcotics, benzodiazepines); if the research assistant is unclear about a specific medication, the physician on the study (Dr. Rick Hecht) will be asked and will decide;
- health behaviors that could affect respiration (e.g., DSM-IV diagnosis of substance use disorder, use of major recreational drugs in the past year-heroin, cocaine, etc.);
- any high-level training in a field that could impact body awareness and is not associated with mind-body practices (e.g., professional athletes or dancers, marathon runners);
- lack of ability to speak and read English fluently (instructions and questionnaires will be in English only and foreign language translations will have to await future studies);
- For participants who consent to the fMRI study, exclusion criteria include contra-indications for safety and data quality in the MRI scanner (see MRI screening form): presence of ferromagnetic metal on or in the body, pregnancy, movement disorder which prevents lying still in the scanner, claustrophobia, braces, and corrected vision that is not within +/- 8.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Meditators
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.
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Controls
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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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.
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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.
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Outcome measure will be assessed once at the baseline fMRI scan to develop the pilot fMRI task.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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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.
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Using EMBODY Task metrics, investigators will calculate how much time people pay attention to their breath during meditation
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Outcome measure will be assessed once at the baseline fMRI scan to develop the pilot fMRI task.
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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.
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Using EMBODY Task metrics, investigators will calculate how much time people were mind wandering during meditation
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Outcome measure will be assessed once at the baseline fMRI scan to develop the pilot fMRI task.
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Questionnaire measures of attention
Time Frame: Measures will be assessed before the fMRI scan session.
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To validate the EMBODY Task, investigators will administer self-report measures of attention, mindfulness, and body awareness
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Measures will be assessed before the fMRI scan session.
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Helen Y Weng, PhD, University of California, San Francisco
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 15-16716
- K08AT009385 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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