Stroke SequelaeNCT03229902
Mantra Meditation in Subjects That Have Chronically Impaired Attention After Stroke
A study testing mantra meditation in people with Stroke Sequelae, run by Cheryl Carrico at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Stroke Sequelae
- What is being tested?
- mantra meditation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2017to 9 Mar 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Non-Concurrent, Multiple-Baseline, Across-Subjects Trial of Mantra Meditation in Subjects That Have Chronically Impaired Attention After Stroke
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.
Read the 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
- Being tested
- mantra meditation
- Keywords
- stroke
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mantra meditationBehavioural
see study description
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: mantra meditation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: through study completion; average of 4 weeks
Secondary outcomes (2)
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).
Measured: through study completion; average of 4 weeks
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).
Measured: through study completion; average of 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2017
- Study start1 May 2017
- Primary completion9 Mar 2018
- Study completion9 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke SequelaeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Intervention model
- Sequential
- Model description
- single-case research design involving a series of AB designs
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cheryl Carrico
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Cheryl Carrico, University of Kentucky
- Investigators
- Cheryl Carrico, M.S., Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03229902
- Sponsor's protocol ID
- 170013F6A
- Status last verified
- Jun 2019
- First submitted
- 20 Jul 2017
- Last updated
- 6 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Non-Concurrent, Multiple-Baseline, Across-Subjects Trial of Mantra Meditation in Subjects That Have Chronically Impaired Attention After Stroke
- ClinicalTrials.gov ID
- NCT03229902
- Acronym / sponsor ID
- 170013F6A
- Conditions
- Stroke Sequelae
- Keywords
- stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Cheryl CarricoUniversity, hospital or other
- Study start
- 1 May 2017 (actual)
- Primary completion
- 9 Mar 2018 (actual)
- Study completion
- 9 Mar 2018 (actual)
- First posted
- 26 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- single-case research design involving a series of AB designs
| Arm | Type | Receives |
|---|---|---|
| mantra meditation | Experimental | Behavioral: mantra meditationEach 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mantra meditationsee study description | Behavioural | mantra meditation |
Primary outcome
Sustained Attention to Response Task, Fixed Version
Time frame: through study completion; average of 4 weeks
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.
2 secondary outcomes
Trail-Making Test (TMT)
Time frame: through study completion; average of 4 weeks
Cognitive Failures Questionnaire
Time frame: through study completion; average of 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2019.
- Individual participant dataSharing planned: No
Related trials for Stroke Sequelae
Enrolling by invitationObservational study
Psychometric Study of the Spanish Version of Two Upper Limb Assessment Scales in Chronic Stroke
Chronic Stroke
Not yet recruitingPhase 2
ALT001 in Patients With Ischemic Stroke in the Sequelae Stage
Ischemic Stroke in the Sequelae Stage
Not yet recruiting
Effects of Different-Frequency Electroacupuncture on Suprahyoid Muscles in Post-Stroke Dysphagia: Efficacy and Neural Networks
Stroke Sequelae, Deglutition Disorders
Active, not recruitingObservational study
A Study to Estimate How Often Post-stroke Spasticity Occurs and to Provide a Standard Guideline on the Best Way to Monitor Its Development
Spasticity as Sequela of Stroke
Recruiting
TDCS to Improve Post-Stroke Cognitive Impairment
Stroke, Stroke Sequelae
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cheryl Carrico, M.S. principal investigator
University of Kentucky
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mantra meditation in people with Stroke Sequelae, run by Cheryl Carrico at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sustained Attention to Response Task, Fixed Version (time frame: through study completion; average of 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2019.