Mindfulness Meditation for Subjects With Severe Speech and Physical Impairments
Condition: Physical Impairments; Cerebral Palsy; Cerebral Ataxia; locked-in Syndrome
MeSH terms: Cerebral Palsy; Ataxia; Locked-In Syndrome
Study type: Interventional

Summary: 
      The purpose of this protocol is to (1) Determine whether a one-on-one mindfulness meditation
      intervention or audio training improves performance on an adaptive communication system that
      utilizes brain-computer interface (BCI); and (2) Determine whether the intervention reduces
      stress in subjects with severe speech and physical impairments (SSPI).

      Hypothesis: The group of subjects randomized to the mindfulness meditation training will
      improve BCI performance and stress levels more than the audio control group.
    

Detailed description: 
      Members of the research team will visit subjects' homes for 9 visits that will each last no
      longer than 2 hours. During the consenting process, participants may opt out of
      photograph/video recordings of their visits, and they will also be able to choose whether or
      not they would like their data to be stored in a repository. At the Initial visit, one or
      more research assistants will visit participants' homes to go over the consent with them and
      answer any questions they may have. Participants will then complete a computer-based
      attention task. For this task, they will watch letters flash quickly on a screen, and then
      they will be asked a "yes/no" question about each series of letters. The computer task will
      take 20-60 minutes, and the entire visit will last no longer than 2 hours.

      Researchers will return to participants' homes within two weeks to complete a Baseline visit.
      At this time, the investigators will administer the same computer-based attention task. The
      investigators will also do an EEG recording during a BCI "mastery task," in which
      participants will try to spell words by looking at a series of letters presented on computer
      screen. During the "mastery task," the investigators will take a recording called an
      electroencephalogram (EEG). Participants will be fitted with a cap (much like a swimming cap)
      with electrodes (small metal sensors that measure electricity). The investigators will place
      a small amount of electrode gel on the scalp at each electrode site. The "mastery task" will
      take no longer than 60 minutes.

      After the visit, participants will then be emailed an internet-based survey that takes
      approximately one hour to complete. They will be asked questions about self-perceived stress,
      feelings and emotions, sleep, how well they think they can pay attention, and their opinions
      about meditation. This will take approximately 1 hour to complete.

      After completing the online surveys, participants will be randomized to receive either an
      audio or meditation training. The first training is approximately 2 hours long. If they have
      been randomly selected to receive the audio training, they will listen to and discuss
      podcasts with the instructor. If they have been randomly selected to receive the meditation
      training, they will learn about mindfulness, do an awareness exercise, listen to a guided
      meditation, and receive mindfulness handouts. They will be given an iPod Touch with either
      podcasts or guided meditations on it (depending on the group assignment) for the duration of
      the class, along with headphones and/or speakers.

      Participants will be asked to do approximately 30 minutes of practice each day, or as much as
      they are able. They will be asked to record how much they practice. Though this is optional,
      many people find it helpful to keep a log of their practice. For others, it may feel too
      burdensome or infeasible. Participants will be able to choose whether or not they want to
      keep a record of their practice. The iPod Touch will record when and for how long they
      listen. At the end of the class, they will be given a CD with all of the guided meditations
      on it.

      If participants receive meditation trainings, the instructor will give them some questions to
      think about before the next visit. They may contemplate and share about the questions via
      email to whatever extent they choose. The instructor will respond to their emails if they
      have any urgent needs and talk with participants about their responses at the
      audio/meditation training visits. Throughout the study, regardless of which group
      participants are in, they may choose to communicate however much they like-it could be very
      little, or they may wish to spend several hours a week emailing reflections, observations,
      and questions about their audio/meditation practice. This is entirely up to individual
      participants.

      The investigators will go to participants home for five more meditation training sessions.
      For the meditation group, participants will be asked to do a meditation right before the
      instructor arrives. Each training session is about 90 minutes long.

      After the meditation/audio training has been completed, the investigators will conduct the
      Endpoint visit, which is the same as the Baseline visit and takes approximately 2 hours. It
      includes the "mastery task" and the computer-based attention task. After the visit,
      participants will be emailed the same online questionnaire about stress, emotions, sleep,
      attention, and meditation. This will take approximately 1 hour to complete. Participants will
      also be emailed some questions to get their feedback about how the research study went for
      them. Offering thoughtful responses to the questions will likely take approximately 30
      minutes.

      After the baseline and endpoint, an online questionnaire will be emailed to the participants.
      It is a series of several surveys: the Perceived Stress Scale (PSS) is a 10-question
      instrument that utilizes a likert scale and measures self-perceived stress during the past
      week. The Positive and Negative Affect Scale (PANAS) will also be administered. It is also 10
      questions and uses a likert scale. It consists of words that describe feelings and emotions,
      and participants are to indicate the extent to which they generally feel that way. The APT-II
      Attention Questionnaire gathers information about participants' self-perceived ability to pay
      attention. The Pittsburgh Sleep Quality Index (PSQI) asks questions about sleep. And the
      Attitudes Toward Study solicits information about participants' thoughts and feelings on
      meditation (the wording of the Pre- and Post- tests vary only slightly).
    

Intervention name(s): Mindfulness Meditation Training; Audio Group
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 6-week, one-on-one meditation training. 90-minute home study visit once per week with research assistant. Learn Mindfulness-Based Cognitive Therapy curriculum and mindfulness techniques, and are asked to practice guided meditations 30-45 minutes each day.; Listen to 30-minute podcasts on a daily basis, and discuss podcasts with research assistant at 90-minute weekly home visits. 6 weeks total.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Mindfulness; Meditation; acute lateral sclerosis; Cerebral Palsy; Cerebral Ataxia; Locked-in Syndrome