Back to resultsMantra Meditation in Subjects That Have Chronically Impaired Attention After Stroke
Primary Purpose
Stroke Sequelae
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
mantra meditation
Sponsored by
About this trial
This is an interventional treatment trial for Stroke Sequelae focused on measuring stroke
Eligibility Criteria
Inclusion Criteria.
- Adults between the ages of 18 and 70
- Chronic, non-lacunar, right-hemisphere stroke (i.e., sustained at >12 months prior to date of clinical screen)
- Severely impaired attention defined as 5 or more errors of commission on the SARTfixed
- 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).
- Right-handed dominance as well as sufficient movement and vision function for testing (use of computer mouse, keyboard, and monitor)
- English language fluency and reading comprehension at least at 6th grade level
Exclusion Criteria.
- Depression defined as a score of >10 on Beck Depression Inventory, Short Form (BDI-SF)
- Current or significant history of substance abuse
- In the 3 months preceding enrollment, change in medications that impact neuroplasticity
- Current participation in any other research study, cognitive rehabilitation, meditation, or mental training program, including commercial brain-training programs
- Neurological disorder other than stroke (e.g., Parkinson's disorder; multiple sclerosis; traumatic brain injury)
- Spatial attention deficit (unilateral neglect) defined as a score of 51 or fewer cancellations on the Star Cancellation Test.
- 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.
- Uncontrolled or severe mental or cognitive disorder with low psychosocial functioning, such as untreated schizophrenia, bipolar disorder, or autism
Sites / Locations
- University of Kentucky
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
mantra meditation
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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).
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).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03229902
Brief Title
Mantra Meditation in Subjects That Have Chronically Impaired Attention After Stroke
Official Title
A Non-Concurrent, Multiple-Baseline, Across-Subjects Trial of Mantra Meditation in Subjects That Have Chronically Impaired Attention After Stroke
Study Type
Interventional
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
May 1, 2017 (Actual)
Primary Completion Date
March 9, 2018 (Actual)
Study Completion Date
March 9, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Cheryl Carrico
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke Sequelae
Keywords
stroke
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
single-case research design involving a series of AB designs
Masking
None (Open Label)
Enrollment
3 (Actual)
8. Arms, Groups, and Interventions
Arm Title
mantra meditation
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
mantra meditation
Intervention Description
see study description
Primary Outcome Measure Information:
Title
Sustained Attention to Response Task, Fixed Version
Description
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
Secondary Outcome Measure Information:
Title
Trail-Making Test (TMT)
Description
• 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
Title
Cognitive Failures Questionnaire
Description
• 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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria.
Adults between the ages of 18 and 70
Chronic, non-lacunar, right-hemisphere stroke (i.e., sustained at >12 months prior to date of clinical screen)
Severely impaired attention defined as 5 or more errors of commission on the SARTfixed
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).
Right-handed dominance as well as sufficient movement and vision function for testing (use of computer mouse, keyboard, and monitor)
English language fluency and reading comprehension at least at 6th grade level
Exclusion Criteria.
Depression defined as a score of >10 on Beck Depression Inventory, Short Form (BDI-SF)
Current or significant history of substance abuse
In the 3 months preceding enrollment, change in medications that impact neuroplasticity
Current participation in any other research study, cognitive rehabilitation, meditation, or mental training program, including commercial brain-training programs
Neurological disorder other than stroke (e.g., Parkinson's disorder; multiple sclerosis; traumatic brain injury)
Spatial attention deficit (unilateral neglect) defined as a score of 51 or fewer cancellations on the Star Cancellation Test.
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.
Uncontrolled or severe mental or cognitive disorder with low psychosocial functioning, such as untreated schizophrenia, bipolar disorder, or autism
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cheryl Carrico, M.S.
Organizational Affiliation
University of Kentucky
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Kentucky
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40504
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Mantra Meditation in Subjects That Have Chronically Impaired Attention After Stroke
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