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临床试验/NCT01964664
NCT01964664已完成不适用

Mindfulness Meditation for Subjects With Severe Speech and Physical Impairments

Oregon Health and Science University2 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2013年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
8
试验地点
2
主要终点
Change from Baseline in Working Memory at 8 weeks (post intervention)

研究概览

简要总结

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.

详细描述

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 opinions about meditation. This will take approximately 1 hour to complete.

After completing the online surveys, participants will be randomized to receive either an audio or meditation training. The first training is approximately 2 hours long. If they have been randomly selected to receive the audio training, they will listen to and discuss podcasts with the instructor. If they have been randomly selected to receive the meditation training, they will learn about mindfulness, do an awareness exercise, listen to a guided meditation, and receive mindfulness handouts. They will be given an iPod Touch with either podcasts or guided meditations on it (depending on the group assignment) for the duration of the class, along with headphones and/or speakers.

Participants will be asked to do approximately 30 minutes of practice each day, or as much as they are able. They will be asked to record how much they practice. Though this is optional, many people find it helpful to keep a log of their practice. For others, it may feel too burdensome or infeasible. Participants will be able to choose whether or not they want to keep a record of their practice. The iPod Touch will record when and for how long they listen. At the end of the class, they will be given a CD with all of the guided meditations on it.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

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

结局指标

主要结局

Change from Baseline in Working Memory at 8 weeks (post intervention)

时间窗: 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).

次要结局

  • Change from Baseline in performance on BCI spelling task at 8 weeks (post intervention)(Baseline and Endpoint, within 1.5 weeks of intervention)
  • Change from Baseline in Perceived Stress Scale at 8 weeks (post intervention)(Baseline and endpoint, within 1.5 weeks before and after intervention)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Barry S. Oken

Barry S. Oken, MD

Oregon Health and Science University

研究点 (2)

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