MEG Study of Mindfulness Based Stress Reduction
Condition: Somatosensory Cortical Dynamics in Normal Humans
Study type: Interventional

Summary: 
      The purpose of this research is to investigate the effects of mindfulness based stress
      reduction (MBSR) on measures of brain function. We are looking especially at the ways in
      which MBSR may affect the way the brain processes the sense of touch. The study seeks to
      recruit healthy, normal adults who are interested in MBSR training, a simple program that
      involves learning how to pay attention mindfully to the present moment
    

Detailed description: 
      In this study, investigators will randomly assign volunteers to one of two conditions: (1)
      attend classes to learn MBSR (2) be on a waitlist on which volunteers will continue your
      activities until the conclusion of the study, at which point they will be offered free MBSR
      training. The MBSR class and the body scan classes will be videotape-recorded in order to
      ensure that the instruction meets study standards. Since the videotape will capture your
      image and voice, you will be identifiable. However, this videotape will only be viewed by
      HIPAA certified study staff; it will be stored in a locked drawer and will be destroyed 36
      months after the completion of the study.

      Random assignment works like the flip of a coin. A volunteer has a 1 in 3 chance of receiving
      MBSR, being asked to continue with his or her normal life, or being asked to practice body
      scanning. At any time and for any reason at all a volunteer may decide to withdraw from the
      study. Data about volunteers' experiences, brain structure, and function collected from this
      study will be stored by investigators at the Osher Institute, Harvard Medical School.

      If a volunteer is randomly assigned to receive MBSR, he or she will be asked to attend 8
      class sessions of training which will last 2 hours each. He or she will also be asked to
      attend a 5 hour retreat. In MBSR classes, you will receive instruction in mindfulness based
      body scan meditation. In addition, a subject assigned to MBSR will receive instruction in
      sitting meditation and in gentle yoga. Participants in both classes will also be asked to
      reflect on their meditation experiences during class and will be asked to consider carrying
      out a home practice during the week, outside of class. MBSR and body scan classes will meet
      at a meditation class facility convenient to a red line T stop in Cambridge.

      Study assessment visits to the Martinos Center facility in Charlestown

      In this study, there are 3 study assessment visits to the Martinos Center facility in
      Charlestown in which volunteers will be asked questions about their daily experience. At all
      3 study visits, investigators will also record magnetic field readings of the brain using a
      non-invasive imaging technique known as magnetoencephalography (MEG). MEG is a technique that
      measures the small electrical currents produced when cells in the brain are active. This
      activity is sometimes called "brain waves."

      During these recordings, we will also be lightly touching volunteers' left hand and left foot
      with a plastic knob. We will be asking volunteers to tell us when they think that they can
      the stimulus.

      To help us interpret the MEG magnetic field readings, at a volunteer's first visit we will
      also use magnetic resonance imaging (MRI) to create an image of his/her brain. MRI is a
      technique that uses magnetic fields to align the spinning of atoms in water molecules. It
      then creates an image of the brain and its activity from the tiny amounts of energy released
      when the atoms relax to their normal state. Structural MRI will give us information about the
      anatomy of the brain.

      At each of the 3 study visits, before a subject begins the brain scans, he/she will be asked
      to complete two tests. The first test has an assistant lightly press plastic domes on his/her
      fingertips. The domes have grooves, and he/she will be asked to tell us which way the grooves
      point. The second test asks him/her to find numbers that will appear on a screen with
      flashing letters.

      Volunteers will also be given questions about daily experience. In addition, at visits 2 and
      3, if a subject is assigned to receive MBSR, investigators will ask about experiences with
      MBSR practice.

      Schedule of assessment procedures in visits 1-3:

        -  Visit 1 involves the following procedures:

             -  Receiving a magnetic resonance imaging (MRI) brain scan.

             -  Doing the dome test and numbers test

             -  Filling out brief questionnaires about activities that performed with the hand, and
                feelings and experiences in general.

             -  Undergoing a magnetoencephalography (MEG) recording of brain function.

        -  Visit 2 involves the following procedures:

             -  Doing the dome test and numbers test

             -  Filling out brief questionnaires about feelings and experiences in general and
                feelings and experiences related to MBSR.

             -  Undergoing a magnetoencephalography (MEG) recording of brain function.

        -  Visit 3 involves the following procedures:

             -  Doing the dome test and numbers test

             -  Filling out brief questionnaires about feelings and experiences in general and
                feelings and experiences related to MBSR.

             -  Undergoing a magnetoencephalography (MEG) recording of brain function.

      Each of the 3 study visits to the Martinos Center will last up to 2 hours and 30 minutes.

      Optional MBSR class for subjects assigned to waitlist

      If a subject is assigned to the waitlist, he/she will have the option of enrolling in a free
      MBSR class after the completion of study visits to the Martinos Center. This free class will
      be taught by the chief mindfulness teacher who is a certified MBSR instructor. This free
      class is offered to only as a courtesy expression of thanks for participating in this study.
      This free class is not a research study: no research data will be collected in this courtesy
      class; subjects are free to participate or to refuse to participate in this post-study
      optional class.
    

Intervention name(s): Mindfulness Based Stress Reduction
Intervention type(s): Behavioral
Intervention description(s): 8 week course in mindfulness training
Other intervention name(s): Course is modelled on course taught by Center for Mindfulness, UMASS Worcester. Instructor and lesson plan are certified by Center for Mindfulness
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Basic Science
Keywords: MEG, mindfulness, tactile perception