Mantra Meditation in Subjects That Have Chronically Impaired Attention After Stroke

NCT ID: NCT03229902

Last Updated: 2019-06-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-01
• Study Completion Date: 2018-03-09

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.

Conditions

Stroke Sequelae

Study Design

• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

mantra meditation

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.

Group Type: EXPERIMENTAL

mantra meditation

Intervention Type: BEHAVIORAL

see study description

Interventions

mantra meditation

see study description

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cheryl Carrico

OTHER

Sponsor Role: lead

Responsible Party

Cheryl Carrico

principal investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Cheryl Carrico, M.S.

Role: PRINCIPAL_INVESTIGATOR

University of Kentucky

Locations

University of Kentucky

Lexington, Kentucky, United States

Countries

United States

Other Identifiers

170013F6A

Identifier Type: -

Identifier Source: org_study_id