Mindfulness Meditation for Subjects With Severe Speech and Physical Impairments

NCT01964664 | Completed

• 1 other identifier: 8912
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Physical Impairments; Cerebral Palsy; Cerebral Ataxia; locked-in Syndrome

Keywords

Mindfulness; Meditation; acute lateral sclerosis; Cerebral Palsy; Cerebral Ataxia; Locked-in Syndrome

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in Working Memory at 8 weeks (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).

  Baseline and Endpoint (within 1.5 weeks pre and post intervention)

Secondary Outcomes (2)

• Change from Baseline in Perceived Stress Scale at 8 weeks (post intervention)

  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)

  Baseline and Endpoint, within 1.5 weeks of intervention

Study Arms (2)

Mindfulness meditation training

EXPERIMENTAL

6-week, one-on-one, mindfulness meditation intervention based on Mindfulness-Based Cognitive Therapy program

Behavioral: Mindfulness Meditation Training

Audio Group

ACTIVE COMPARATOR

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

Interventions

Mindfulness Meditation Training BEHAVIORAL

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.

Mindfulness meditation training

Audio Group BEHAVIORAL

Listen to 30-minute podcasts on a daily basis, and discuss podcasts with research assistant at 90-minute weekly home visits. 6 weeks total.

Audio Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Have full ability to communicate verbally and with writing/typing

Sponsors & Collaborators

• Oregon Health and Science University: lead

Study Sites (1)

Participant Homes

Portland Metropolitan Area, Oregon, 97236, United States

Location

MeSH Terms

Conditions

Cerebral Palsy; Locked-In Syndrome

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Quadriplegia; Paralysis; Neurologic Manifestations; Neuromuscular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Barry Oken, MD

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Barry S. Oken, MD

Study Record Dates

• First Submitted: July 9, 2013
• First Posted: October 17, 2013
• Study Start: January 1, 2013
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: April 13, 2017

Record last verified: 2017-04

Locations

US (1)