Evaluating Multivariate MRI Maps of Body Awareness

NCT03344081 | Completed DMC

• 2 other identifiers: 15-16716K08AT009385
• Study Type: observational
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

Meditation skills, or paying attention to internal mental states, are thought to improve people's health. This study is developing a new brain measure of meditation skills, called the EMBODY Task, using functional magnetic resonance imaging (fMRI). The investigators are testing whether pattern recognition methods can be applied to fMRI data to identify mental states during meditation, including attention to the body and to thoughts. This task is being developed in meditation practitioners and non-meditators. The goal is to understand what people are paying attention to during meditation using brain data. The investigators hypothesize that pattern recognition technology will be able to identify different mental states that occur during meditation.

Conditions

Attention

Keywords

attention; interoception; meditation; mind wandering

Outcome Measures

Primary Outcomes (1)

• Classification accuracy of brain patterns from EMBODY 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.

  Outcome measure will be assessed once at the baseline fMRI scan to develop the pilot fMRI task.

Secondary Outcomes (2)

• Percentage time paying attention to breath during meditation

  Outcome measure will be assessed once at the baseline fMRI scan to develop the pilot fMRI task.

• Percentage time spent mind wandering during meditation

  Outcome measure will be assessed once at the baseline fMRI scan to develop the pilot fMRI task.

Other Outcomes (1)

• Questionnaire measures of attention

  Measures will be assessed before the fMRI scan session.

Study Arms (2)

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.

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.

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study is designed for healthy adults, some of whom have extended meditation practice (at least 5 years), and some who have little or no meditation experience.

You may qualify if:

• 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).

You may not qualify if:

• 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);

Sponsors & Collaborators

• University of California, San Francisco: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator
• Mind and Life Institute, Hadley, Massachusetts: collaborator

Study Sites (1)

Osher Center for Integrative Medicine

San Francisco, California, 94117, United States

Location

Related Publications (1)

• Weng HY, Lewis-Peacock JA, Hecht FM, Uncapher MR, Ziegler DA, Farb NAS, Goldman V, Skinner S, Duncan LG, Chao MT, Gazzaley A. Focus on the Breath: Brain Decoding Reveals Internal States of Attention During Meditation. Front Hum Neurosci. 2020 Aug 28;14:336. doi: 10.3389/fnhum.2020.00336. eCollection 2020.

  PMID: 33005138 RESULT

Study Officials

• Helen Y Weng, PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2017
• First Posted: November 17, 2017
• Study Start: June 1, 2016
• Primary Completion: July 11, 2019
• Study Completion: July 11, 2019
• Last Updated: September 16, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Upon publication in the supplementary material
• Access Criteria: Available upon publication

Locations

US (1)