Mindfulness Meditation for Subjects With Severe Speech and Physical Impairments (MSPi)
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.
|Physical Impairments Cerebral Palsy Cerebral Ataxia locked-in Syndrome||Behavioral: Mindfulness Meditation Training Behavioral: Audio Group|
|Study Design:||Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
|Official Title:||Mindfulness Meditation for Subjects With Severe Speech and Physical Impairments|
- 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).
- 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
|Study Start Date:||January 2013|
|Study Completion Date:||October 2016|
|Primary Completion Date:||October 2016 (Final data collection date for primary outcome measure)|
Experimental: Mindfulness meditation training
6-week, one-on-one, mindfulness meditation intervention based on Mindfulness-Based Cognitive Therapy program
Behavioral: Mindfulness Meditation Training
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.
Active Comparator: Audio Group
6 weeks of listening to podcasts daily (same length as guided meditations), and discussing podcast content with research assistant during weekly study visits
Behavioral: Audio Group
Listen to 30-minute podcasts on a daily basis, and discuss podcasts with research assistant at 90-minute weekly home visits. 6 weeks total.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01964664
|United States, Oregon|
|Portland Metropolitan Area, Oregon, United States, 97236|
|Principal Investigator:||Barry Oken, MD||Oregon Health and Science University|