An interventional study of mantra meditation in Stroke Sequelae, sponsored by Cheryl Carrico. Completed at 1 site in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2019-06-06.
Sponsored by Cheryl Carrico · Not applicable, Interventional, and Treatment
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.
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.
7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.
This study's enrollment of 3 is below the median of 50 across 5,369 interventional studies indexed under Stroke.
Browse Stroke studies →This is the only study on the registry with Cheryl Carrico as lead sponsor.
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Exclusion Criteria.
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.
Behavioral: mantra meditation
see study description
Sustained Attention to Response Task, Fixed Version
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.
Time frame: through study completion; average of 4 weeks
Trail-Making Test (TMT)
• TMT is a 5-minute pencil-and-paper test that has been extensively used as a measure of executive function as well as a measure of attention in a study of meditation to improve attention after stroke (Johansson, Bjuhr, \& Rönnbäck, 2012).
Time frame: through study completion; average of 4 weeks
Cognitive Failures Questionnaire
• CFQ is a 25-item pencil-and-paper questionnaire that uses a self-report scale 1-5 on which subjects identify difficulty in everyday cognitive functioning. CFQ measures 4 cognitive constructs (Distractibility, Memory, Blunders and Naming) and has been used in research, as well as clinically, to measure sustained attention after stroke (Shalev, Humphreys, \& Demeyere, 2016).
Time frame: through study completion; average of 4 weeks
Plan to share: No
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This study is completed, as verified in Jun 2019. You cannot join it, but the record below documents what was studied.
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