<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03229902</url>
  </required_header>
  <id_info>
    <org_study_id>170013F6A</org_study_id>
    <nct_id>NCT03229902</nct_id>
  </id_info>
  <brief_title>Mantra Meditation in Subjects That Have Chronically Impaired Attention After Stroke</brief_title>
  <official_title>A Non-Concurrent, Multiple-Baseline, Across-Subjects Trial of Mantra Meditation in Subjects That Have Chronically Impaired Attention After Stroke</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cheryl Carrico</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Kentucky</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      There is an evidence gap on whether meditation may improve behaviorally measured attention&#xD;
      after stroke, but preliminary research is promising. This study is the first-ever&#xD;
      investigation of whether mantra meditation may improve chronic, severe impairment in&#xD;
      attention after stroke.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study is non-concurrent, multiple-baseline, across-subjects, single-case research design&#xD;
      (SCRD). The central hypothesis is that mantra meditation (independent variable) will be&#xD;
      associated with improvement on 1 or more tests of behaviorally measured sustained attention&#xD;
      (dependent variable). The mantra in this study is the syllable &quot;um&quot; and is not assigned any&#xD;
      spiritual, religious, or affective meaning. The mantra is repeated aloud together by the&#xD;
      subject and the PI for a duration of 30 minutes in each session. This procedure constitutes&#xD;
      meditation for the purposes of this study. There are 9 session of meditation (3 times per&#xD;
      week for 3 weeks). Attention is measured in each of these sessions as well as in 3 separate&#xD;
      testing sessions that precede the intervention period.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 1, 2017</start_date>
  <completion_date type="Actual">March 9, 2018</completion_date>
  <primary_completion_date type="Actual">March 9, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <intervention_model>Sequential Assignment</intervention_model>
    <intervention_model_description>single-case research design involving a series of AB designs</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Sustained Attention to Response Task, Fixed Version</measure>
    <time_frame>through study completion; average of 4 weeks</time_frame>
    <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, &amp; 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, &amp; 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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Trail-Making Test (TMT)</measure>
    <time_frame>through study completion; average of 4 weeks</time_frame>
    <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, &amp; Rönnbäck, 2012).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cognitive Failures Questionnaire</measure>
    <time_frame>through study completion; average of 4 weeks</time_frame>
    <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, &amp; Demeyere, 2016).</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">3</enrollment>
  <condition>Stroke Sequelae</condition>
  <arm_group>
    <arm_group_label>mantra meditation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>mantra meditation</intervention_name>
    <description>see study description</description>
    <arm_group_label>mantra meditation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria.&#xD;
&#xD;
          1. Adults between the ages of 18 and 70&#xD;
&#xD;
          2. Chronic, non-lacunar, right-hemisphere stroke (i.e., sustained at &gt;12 months prior to&#xD;
             date of clinical screen)&#xD;
&#xD;
          3. Severely impaired attention defined as 5 or more errors of commission on the SARTfixed&#xD;
&#xD;
          4. Intact consent capacity with no evidence of dementia, defined as a score of 100%&#xD;
             correct answer rate on University of California, San Diego Brief Assessment of&#xD;
             Capacity to Consent (UBACC).&#xD;
&#xD;
          5. Right-handed dominance as well as sufficient movement and vision function for testing&#xD;
             (use of computer mouse, keyboard, and monitor)&#xD;
&#xD;
          6. English language fluency and reading comprehension at least at 6th grade level&#xD;
&#xD;
        Exclusion Criteria.&#xD;
&#xD;
          1. Depression defined as a score of &gt;10 on Beck Depression Inventory, Short Form (BDI-SF)&#xD;
&#xD;
          2. Current or significant history of substance abuse&#xD;
&#xD;
          3. In the 3 months preceding enrollment, change in medications that impact&#xD;
             neuroplasticity&#xD;
&#xD;
          4. Current participation in any other research study, cognitive rehabilitation,&#xD;
             meditation, or mental training program, including commercial brain-training programs&#xD;
&#xD;
          5. Neurological disorder other than stroke (e.g., Parkinson's disorder; multiple&#xD;
             sclerosis; traumatic brain injury)&#xD;
&#xD;
          6. Spatial attention deficit (unilateral neglect) defined as a score of 51 or fewer&#xD;
             cancellations on the Star Cancellation Test.&#xD;
&#xD;
          7. According to the clinical judgement of the PI or her authorized designee, any other&#xD;
             functional impairment which would significantly deter comprehension and/or execution&#xD;
             of the requirements of the trial, such as aphasia, hearing deficit, or mobility&#xD;
             deficit restricting navigation to, from, and within the research site. Subjects must&#xD;
             be able to provide their own transportation to and from the study site.&#xD;
&#xD;
          8. Uncontrolled or severe mental or cognitive disorder with low psychosocial functioning,&#xD;
             such as untreated schizophrenia, bipolar disorder, or autism&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Cheryl Carrico, M.S.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Kentucky</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Kentucky</name>
      <address>
        <city>Lexington</city>
        <state>Kentucky</state>
        <zip>40504</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2019</verification_date>
  <study_first_submitted>July 20, 2017</study_first_submitted>
  <study_first_submitted_qc>July 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 26, 2017</study_first_posted>
  <last_update_submitted>June 4, 2019</last_update_submitted>
  <last_update_submitted_qc>June 4, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">June 6, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of Kentucky</investigator_affiliation>
    <investigator_full_name>Cheryl Carrico</investigator_full_name>
    <investigator_title>principal investigator</investigator_title>
  </responsible_party>
  <keyword>stroke</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03229902
org study id: 170013F6A
nct id: NCT03229902
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
intervention model: Sequential Assignment
intervention model description: single-case research design involving a series of AB designs
primary purpose: Treatment
masking: None (Open Label)
measure: Sustained Attention to Response Task, Fixed Version
time frame: through study completion; average of 4 weeks
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.
measure: Trail-Making Test (TMT)
time frame: through study completion; average of 4 weeks
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).
measure: Cognitive Failures Questionnaire
time frame: through study completion; average of 4 weeks
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).
arm group label: mantra meditation
arm group type: Experimental
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: mantra meditation
description: see study description
arm group label: mantra meditation
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Cheryl Carrico, M.S.
role: Principal Investigator
affiliation: University of Kentucky
facility: 
country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: University of Kentucky
investigator full name: Cheryl Carrico
investigator title: principal investigator
mesh term: Stroke
sharing ipd: No