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临床试验/NCT03229902
NCT03229902已完成不适用

A Non-Concurrent, Multiple-Baseline, Across-Subjects Trial of Mantra Meditation in Subjects That Have Chronically Impaired Attention After Stroke

Cheryl Carrico2 个研究点 分布在 1 个国家目标入组 3 人开始时间: 2017年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
3
试验地点
2
主要终点
Sustained Attention to Response Task, Fixed Version

研究概览

简要总结

There is an evidence gap on whether meditation may improve behaviorally measured attention after stroke, but preliminary research is promising. This study is the first-ever investigation of whether mantra meditation may improve chronic, severe impairment in attention after stroke.

详细描述

The study is non-concurrent, multiple-baseline, across-subjects, single-case research design (SCRD). The central hypothesis is that mantra meditation (independent variable) will be associated with improvement on 1 or more tests of behaviorally measured sustained attention (dependent variable). The mantra in this study is the syllable "um" and is not assigned any spiritual, religious, or affective meaning. The mantra is repeated aloud together by the subject and the PI for a duration of 30 minutes in each session. This procedure constitutes meditation for the purposes of this study. There are 9 session of meditation (3 times per week for 3 weeks). Attention is measured in each of these sessions as well as in 3 separate testing sessions that precede the intervention period.

研究设计

研究类型
Interventional
干预模型
Sequential
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

mantra meditation

Experimental

Each session of mantra meditation lasts for 30 minutes. The participants in each session comprise 1 subject and the PI. In each session, the subject and the PI co-participate in repetitive intonation of a pre-specified mantra. Intervention is comprised of 9 sessions, each of which occurs on a separate weekday at approximately equal intervals over a total intervention period of 3 weeks.

干预措施: mantra meditation (Behavioral)

结局指标

主要结局

Sustained Attention to Response Task, Fixed Version

时间窗: through study completion; average of 4 weeks

SARTfixed is in the class of attention tests called continuous performance tests, a class which has a long history of use to measure sustained attention (Shaleva, Ben-Simon, Mevorachc, Cohen, \& Tsald, 2011). SARTfixed is a 5-minute computerized test based on the standard version of the SART, which was developed to measure sustained attention in subjects with right-hemisphere acquired brain lesions (Robertson, Manly, Andrade, Baddeley, \& Yiend,1997b). Manly and colleagues (2003) demonstrated that in subjects with neurological impairment, SARTfixed was a more pure measurement of sustained attention than standard SART. SARTfixed also had comparatively more likelihood than standard SART for accurately discriminating between healthy volunteers and individuals with neurological impairment.

次要结局

  • Trail-Making Test (TMT)(through study completion; average of 4 weeks)
  • Cognitive Failures Questionnaire(through study completion; average of 4 weeks)

研究者

发起方
Cheryl Carrico
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Cheryl Carrico

principal investigator

University of Kentucky

研究点 (2)

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