Mindfulness Meditation for Subjects With Severe Speech and Physical Impairments (MSPi)
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|ClinicalTrials.gov Identifier: NCT01964664|
Recruitment Status : Completed
First Posted : October 17, 2013
Last Update Posted : April 13, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Physical Impairments Cerebral Palsy Cerebral Ataxia locked-in Syndrome||Behavioral: Mindfulness Meditation Training Behavioral: Audio Group||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||8 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Mindfulness Meditation for Subjects With Severe Speech and Physical Impairments|
|Study Start Date :||January 2013|
|Actual Primary Completion Date :||October 2016|
|Actual Study Completion Date :||October 2016|
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.
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01964664
|United States, Oregon|
|Portland Metropolitan Area, Oregon, United States, 97236|
|Principal Investigator:||Barry Oken, MD||Oregon Health and Science University|