Mantra Meditation in Subjects That Have Chronically Impaired Attention After Stroke

NCT03229902 | Completed

• 1 other identifier: 170013F6A
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke Sequelae

Keywords

stroke

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Trail-Making Test (TMT)

  through study completion; average of 4 weeks

• Cognitive Failures Questionnaire

  through study completion; average of 4 weeks

Study Arms (1)

mantra meditation

EXPERIMENTAL

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

Interventions

mantra meditation BEHAVIORAL

see study description

mantra meditation

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cheryl Carrico: lead

Study Sites (1)

University of Kentucky

Lexington, Kentucky, 40504, United States

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Cheryl Carrico, M.S.

  University of Kentucky

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: principal investigator

Model Details: single-case research design involving a series of AB designs

Study Record Dates

• First Submitted: July 20, 2017
• First Posted: July 26, 2017
• Study Start: May 1, 2017
• Primary Completion: March 9, 2018
• Study Completion: March 9, 2018
• Last Updated: June 6, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)