Mantra Meditation in Subjects That Have Chronically Impaired Attention After Stroke

Stroke Sequelae Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03229902
• Other study ID #: 170013F6A
• Status: Completed
• Phase: N/A
• Start date: May 1, 2017
• Est. completion date: March 9, 2018

Study information

• Verified date: June 2019
• Source: University of Kentucky
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3
• Est. completion date: March 9, 2018
• Est. primary completion date: March 9, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria.

1. Adults between the ages of 18 and 70

2. Chronic, non-lacunar, right-hemisphere stroke (i.e., sustained at >12 months prior to date of clinical screen)

3. Severely impaired attention defined as 5 or more errors of commission on the SARTfixed

4. Intact consent capacity with no evidence of dementia, defined as a score of 100% correct answer rate on University of California, San Diego Brief Assessment of Capacity to Consent (UBACC).

5. Right-handed dominance as well as sufficient movement and vision function for testing (use of computer mouse, keyboard, and monitor)

6. English language fluency and reading comprehension at least at 6th grade level

Exclusion Criteria.

1. Depression defined as a score of >10 on Beck Depression Inventory, Short Form (BDI-SF)

2. Current or significant history of substance abuse

3. In the 3 months preceding enrollment, change in medications that impact neuroplasticity

4. Current participation in any other research study, cognitive rehabilitation, meditation, or mental training program, including commercial brain-training programs

5. Neurological disorder other than stroke (e.g., Parkinson's disorder; multiple sclerosis; traumatic brain injury)

6. Spatial attention deficit (unilateral neglect) defined as a score of 51 or fewer cancellations on the Star Cancellation Test.

7. According to the clinical judgement of the PI or her authorized designee, any other functional impairment which would significantly deter comprehension and/or execution of the requirements of the trial, such as aphasia, hearing deficit, or mobility deficit restricting navigation to, from, and within the research site. Subjects must be able to provide their own transportation to and from the study site.

8. Uncontrolled or severe mental or cognitive disorder with low psychosocial functioning, such as untreated schizophrenia, bipolar disorder, or autism

Related Conditions & MeSH terms

• Stroke
• Stroke Sequelae

Intervention

Behavioral:
• mantra meditation
see study description

Locations

Country	Name	City	State
United States	University of Kentucky	Lexington	Kentucky

Sponsors (1)

Lead Sponsor	Collaborator
Cheryl Carrico

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	through study completion; average of 4 weeks
Secondary	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).	through study completion; average of 4 weeks
Secondary	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).	through study completion; average of 4 weeks