Clinical Trial: Mindfulness Meditation for Subjects With Severe Speech and Physical Impairments

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Mindfulness Meditation for Subjects With Severe Speech and Physical Impairments

Brief 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 Summary:

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
Sponsor: Oregon Health and Science University

Current Primary Outcome: Change from Baseline in Working Memory at 8 weeks (post intervention) [ Time Frame: Baseline and Endpoint (within 1.5 weeks pre and post intervention) ]

Computer-based working memory task, classically titled "N-Back" task. Participants watch a series of letters presented on a screen, one after the other, and they are instructed to watch for letters being repeated 1 back (two in a row), 2 back (one letter in between repeat), etc (adjusted according to ability).


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Change from Baseline in Perceived Stress Scale at 8 weeks (post intervention) [ Time Frame: Baseline and endpoint, within 1.5 weeks before and after intervention ]
  • Change from Baseline in performance on BCI spelling task at 8 weeks (post intervention) [ Time Frame: Baseline and Endpoint, within 1.5 weeks of intervention ]
    Participants use a brain-computer interface system (with EEG) designed for letter-detection


Original Secondary Outcome: Same as current

Information By: Oregon Health and Science University

Dates:
Date Received: July 9, 2013
Date Started: January 2013
Date Completion:
Last Updated: April 11, 2017
Last Verified: April 2017