Mindfulness Meditation for Subjects With Severe Speech and Physical Impairments (MSPi)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Barry S. Oken, Oregon Health and Science University
ClinicalTrials.gov Identifier:
NCT01964664
First received: July 9, 2013
Last updated: October 14, 2013
Last verified: October 2013
  Purpose

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 Intervention Phase
Severe Speech Impairments
Physical Impairments
Acute Lateral Sclerosis
Cerebral Palsy
Cerebral Ataxia
locked-in Syndrome
Behavioral: Mindfulness Meditation Training
Behavioral: Audio Group
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Mindfulness Meditation for Subjects With Severe Speech and Physical Impairments

Resource links provided by NLM:


Further study details as provided by Oregon Health and Science University:

Primary Outcome Measures:
  • Change from Baseline in Working Memory at 8 weeks (post intervention) [ Time Frame: Baseline and Endpoint (within 1.5 weeks pre and post intervention) ] [ Designated as safety issue: No ]
    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).


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
    Participants use a brain-computer interface system (with EEG) designed for letter-detection


Estimated Enrollment: 10
Study Start Date: January 2013
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Have a diagnosis by a neurologist of acquired neuromuscular or neurodevelopmental disorder
  • be capable of participating in 2-hour experimental interactions
  • Be literate in English
  • Be English speaking but not be able to communicate by voice or sign language
  • Have normal or corrected vision and hearing
  • Have speech that is understood less than 25% of the time
  • Have reduced hand function for writing and typing
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01964664

Locations
United States, Oregon
Participant Homes
Portland Metropolitan Area, Oregon, United States, 97236
Sponsors and Collaborators
Oregon Health and Science University
Investigators
Principal Investigator: Barry Oken, MD Oregon Health and Science University
  More Information

No publications provided

Responsible Party: Barry S. Oken, Barry S. Oken, MD, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT01964664     History of Changes
Other Study ID Numbers: 8912
Study First Received: July 9, 2013
Last Updated: October 14, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Oregon Health and Science University:
Mindfulness
Meditation
acute lateral sclerosis
Cerebral Palsy
Cerebral Ataxia
Locked-in Syndrome

Additional relevant MeSH terms:
Speech Disorders
Ataxia
Cerebral Palsy
Quadriplegia
Sclerosis
Motor Neuron Disease
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Paralysis
Pathologic Processes
Neurodegenerative Diseases
Neuromuscular Diseases
Language Disorders
Communication Disorders
Neurobehavioral Manifestations

ClinicalTrials.gov processed this record on July 31, 2014