Clinical trial NCT03229902: 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
Overall status: COMPLETED
Phase: NA
Conditions: Stroke Sequelae
Keywords: stroke
Lead sponsor: University of Kentucky
Sponsor class: OTHER
First posted: 2017-07-26
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Intervention model: SEQUENTIAL
Intervention model description: single-case research design involving a series of AB designs
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Sustained Attention to Response Task, Fixed Version
timeFrame: through study completion; average of 4 weeks
Secondary outcomes:
measure: Trail-Making Test (TMT)
timeFrame: through study completion; average of 4 weeks
measure: Cognitive Failures Questionnaire
timeFrame: through study completion; average of 4 weeks
Other outcomes:
Locations:
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
Study officials:
affiliation: University of Kentucky
name: Cheryl Carrico, M.S.
role: PRINCIPAL_INVESTIGATOR
References: