xml: <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/NCT05984056</url>
    </required_header>
    <id_info>
      <org_study_id>22-941</org_study_id>
      <nct_id>NCT05984056</nct_id>
    </id_info>
    <brief_title>Multidisciplinary Lifestyle Interventions for Neurological Disorders During the Silent Phase</brief_title>
    <acronym>MINDS</acronym>
    <official_title>Multidisciplinary Lifestyle Interventions for Neurological Disorders During the Silent Phase (MINDS)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Vineet Punia MD</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Ohio Department of higher education</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>The Cleveland Clinic</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>
        This clinical trial aims to test the impact of multidisciplinary lifestyle interventions&#xD;
        (MLI) in neurologically healthy but at-risk individuals. It aims to find out:&#xD;
  &#xD;
          -  if giving four different kinds of lifestyle intervention and education slows down or&#xD;
             reverses the expression of neurological disorder or their biomarkers.&#xD;
  &#xD;
          -  new biomarkers that either help in the early detection of neurological disease or&#xD;
             identify the impact of various lifestyle interventions combined.&#xD;
  &#xD;
        Participants will be randomized to the intervention or observation arm. Various biological&#xD;
        samples and tests, along with survey questionnaires, will be performed at the time of&#xD;
        entering the study, at 12 weeks after enrollment, and then at the end of the study at 12&#xD;
        months.&#xD;
  &#xD;
          -  Intervention arm: Participants will receive weekly, instructor-led intervention sessions&#xD;
             (virtual group sessions) for 12 weeks. After the 12-week mark, participants will be&#xD;
             encouraged to practice what they learned for nine more months.&#xD;
  &#xD;
          -  Observation arm: The intervention group will be compared to another group that did not&#xD;
             get the intervention&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        In this prospective, controlled, randomized study, investigators will enroll neurologically&#xD;
        healthy but at-risk individuals (defined based on the pre-defined, disease-specific criteria&#xD;
        described below in the &quot;Eligibility&quot; section) to assess the effectiveness of&#xD;
        multidisciplinary lifestyle interventions (MLI, which include brain health training, yoga,&#xD;
        music therapy, and MINDS diet education) on delaying, preventing, or reversing the&#xD;
        progressive expression of known and novel neurological disorder biomarkers.&#xD;
  &#xD;
        The study team will accomplish the abovementioned objectives by comparing 200 participants&#xD;
        randomly assigned to the MLI arm (12 weekly instructor-led virtual group sessions followed by&#xD;
        nine months of self-practice) or the control arm. All participants (including those enrolled&#xD;
        in the control arm) will receive the MIND Study Activity Survey every two weeks during this&#xD;
        first 12-week period.&#xD;
  &#xD;
        Participants will undergo neuroimaging, neuropsychology, and neurophysiology testing and&#xD;
        provide biosamples for genomic, proteomic, and metabolomic analysis along with various survey&#xD;
        questionnaires at 3-time points: study enrollment, at the 12-week mark, and at the end of the&#xD;
        study (12-month).&#xD;
  &#xD;
        The primary outcome of the study is &quot;pathology progression,&quot; which will be considered&#xD;
        positive when the known biomarker used for initial participant selection increases over the&#xD;
        study period. Rest will be considered as not showing &quot;pathology progression.&quot; Various&#xD;
        biomarkers collected using the abovementioned tests will be compared within and between the&#xD;
        intervention and observation groups, and their correlation to pathology progression will be&#xD;
        analyzed. This longitudinal, correlational testing will help this exploratory study reveal&#xD;
        potential novel biomarkers of early neurological disorder and the ones that show the impact&#xD;
        of MLI.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 13, 2023</start_date>
    <completion_date type="Anticipated">June 2024</completion_date>
    <primary_completion_date type="Anticipated">June 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Prevention</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Pathology progression</measure>
      <time_frame>12 months</time_frame>
      <description>At the time of study completion, a participant will be considered to show &quot;Pathology progression&quot; if they fulfill either of the two conditions:&#xD;
  Clinically diagnosed with any of the above five conditions&#xD;
  Show the following changes compared to the baseline:&#xD;
  Stroke: Asymptomatic cortical infarct or further increase in white matter disease MRI changes&#xD;
  Epilepsy: Increase in burden (per hour) of Spikes/Sharp Waves/Polyspikes or electrographic seizure on EEG&#xD;
  Movement Disorder: &gt;4 points increase on modified Unified Parkinson's Disease Rating Scale (UPDRS) administered remotely&#xD;
  Dementia: Increase in number of domain testing ≤ 1.5 SD or drop in scores &lt; 2SD&#xD;
  Multiple Sclerosis (MS): Increase in the number of MRI lesions or volume of existing lesions</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Quality of Life in Neurological Disorders (Neuro QoL)</measure>
      <time_frame>12 months</time_frame>
      <description>Neuro-QOL uses a 5-point scale for scoring items, with questions ranging from least (1) to most (5) Neuro-QOL uses a T score with a mean of 50 and SD of 10 High scores indicate worse or undesirable, self-reported health.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>PHQ8 (Patient Health Questionnaire)</measure>
      <time_frame>12 months</time_frame>
      <description>It is an eight-item questionnaire used to screen for and assess the severity of depression. The PHQ-8 total score ranges from 0 to 24. A score of 0 to 4 indicates no depression, 5 to 9 indicates mild depression, 10 to 14 indicates moderate depression, 15 to 19 indicates moderately severe depression and 20 or higher indicates severe depression. A score of 10 or greater is considered major depression, and 20 or more is severe major depression.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Generalized Anxiety Disorder Questionnaire-7 (GAD-7)</measure>
      <time_frame>12 months</time_frame>
      <description>A screening instrument used to detect anxiety symptoms. The total score for the seven items in the GAD-7 ranges from 0 to 21. The scores are calculated by assigning scores of 0, 1, 2, and 3 to the response categories of &quot;not at all,&quot; &quot;several days,&quot; &quot;more than half the days,&quot; and &quot;nearly every day&quot;.&#xD;
  The scores are interpreted as follows:&#xD;
  0-4: Minimal anxiety 5-9: Mild anxiety 10-14: Moderate anxiety 15 or greater: Severe anxiety 6-10: Moderate 11-15: Moderately severe anxiety&#xD;
  Scores above 10 are considered to be in the clinical range.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>General Self-Efficacy Scale (GSE)</measure>
      <time_frame>12 months</time_frame>
      <description>The GSE is a 10-item psychometric scale that assesses optimistic self-beliefs to cope with difficult demands in life (coping skills). The minimum score for GSE is 10, and the maximum is 40.&#xD;
  The higher the score, the greater the individual's generalized self-efficacy belief.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>International Physical Activity Questionnaire (IPAQ)</measure>
      <time_frame>12 months</time_frame>
      <description>IPAQ is a well-developed and widely-used instrument to measure physical activity in adults.&#xD;
  The IPAQ scoring protocol assigns the following MET (minutes a week) values to walking, moderate, and vigorous-intensity activity: 3.3 METs, 4.0 METs, and 8.0 METs, respectively. To get a continuous variable score from the IPAQ, you can consider walking to be 3.3 METS, moderate physical activity to be 4 METS, and vigorous physical activity to be 8 METS.&#xD;
  Overall score: Excellent test-retest reliability (ICC = 0.81) Physical activity: Excellent test-retest reliability (ICC = 0.84-1.00) Sitting: Adequate test-retest reliability (ICC = 0.70)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Perceived Stress Scale (PSS-10)</measure>
      <time_frame>12 months</time_frame>
      <description>The Perceived Stress Scale (PSS) is a 10-item questionnaire that evaluates participants' self-reported amount of stress by assessing their thoughts and feelings in the previous month. Each question is scored from 0 (never) to 5 (very often), with a total possible score range of 0 to 40.&#xD;
  Higher scores indicate a higher level of stress.&#xD;
  Here are some cut-off scores for the PSS:&#xD;
  0-13: low stress 14-26: moderate stress 27-40: high perceived stress 14 and 27: cut-off scores for moderate and high perceived stress, respectively The estimated minimal clinically important difference for the PSS-10 is 11 points</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Pittsburgh Sleep Quality Index (PSQI)</measure>
      <time_frame>12 months</time_frame>
      <description>PSQI is a questionnaire that assesses sleep quality and disturbances and has a global score that ranges from 0 to 21 points.&#xD;
  The minimum score is 0, considered better, and the maximum score is 3, considered worse.&#xD;
  The global score is calculated by adding up the average scores of seven factors.&#xD;
  Higher scores indicate worse sleep quality. The developers of the PSQI suggest a cut-off score of 5 for the global scale, as it correctly identified 88.5% of the patient group in their validation study.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patient-Reported Outcomes Measurement Information System (PROMIS)</measure>
      <time_frame>12 months</time_frame>
      <description>PROMIS is a system of measures that evaluates and monitors adults' physical, mental, and social health.&#xD;
  PROMIS scores range from 36.3 to 82.7, with higher scores indicating worse outcome.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">200</enrollment>
    <condition>Neurological Disorder</condition>
    <arm_group>
      <arm_group_label>Intervention</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Multidisciplinary lifestyle interventions will be provided weekly for 12 weeks after enrollment.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>No intervention. Periodic check-ups will be performed during the first 12 weeks, followed by monthly check-ins like the intervention arm.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Multidisciplinary lifestyle interventions</intervention_name>
      <description>Multidisciplinary lifestyle interventions (Brain health training, yoga, music therapy and CC-MIND diet education)</description>
      <arm_group_label>Intervention</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Participants must be enrolled in Cleveland Clinic Brain Study (CCBS). CCBS is a&#xD;
               prospective non-interventional study platform for the hypercharacterization of the&#xD;
               brain and body systems changes (blood, cardio-vascular, voice, visual, cognitive,&#xD;
               digestive, brain structure, and neurophysiology) in neurologically healthy individuals&#xD;
               50 years and older (and first-degree relatives older than 20 years of patients with&#xD;
               multiple sclerosis, a disease that affects younger adults). All individuals undergo&#xD;
               periodic and thorough neurological assessments, blood tests, and cardiac,&#xD;
               neurocognitive, imaging, vision, and neurophysiological testing.&#xD;
  &#xD;
            2. CCBS participants who do not have a clinical neurological disease (except headache)&#xD;
               but show signs of being at risk of developing one of the five conditions based on the&#xD;
               below criteria:&#xD;
  &#xD;
                 -  Stroke: MRI changes consistent with moderate-severe white matter disease on&#xD;
                    Fazekas Scale&#xD;
  &#xD;
                 -  Epilepsy: Spikes/Poylspikes/ Sharp Waves on EEG&#xD;
  &#xD;
                 -  Movement Disorder: Hyposmia on U. Penn Smell Identification Test (UPSIT &lt;10&#xD;
                    percentile based on age)&#xD;
  &#xD;
                 -  Dementia: Auditory Verbal Learning Test (AVLT) Trial 1-5 total or Trial 7 scoring&#xD;
                    &lt;=1.5 SD and subjective memory on BACH score (proprietary test) 0-40&#xD;
  &#xD;
                 -  Multiple Sclerosis (MS): ≥3 MRI lesions ≥2 mm in diameter located in the&#xD;
                    juxtacortical, pericallosal, periventricular, or infratentorial white matter&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Participants who are actively (at the time of enrollment) engaged in 2 or more of the&#xD;
               study interventions.&#xD;
  &#xD;
            2. Participants with a diagnosed, symptomatic, chronic illness (i.e., significant&#xD;
               psychiatric concerns, liver, gastrointestinal, respiratory, renal, cardiac, etc.) who,&#xD;
               based on primary investigator review, cannot safely or effectively participate in the&#xD;
               study.&#xD;
  &#xD;
            3. Participants undergoing intensive medical treatment for serious or life-threatening&#xD;
               illness (e.g., chemotherapy, etc.) that, in an investigator's opinion, would impact&#xD;
               study participation.&#xD;
  &#xD;
            4. Participants who are currently pregnant or less than six weeks postpartum&#xD;
  &#xD;
            5. Participants with significant hearing loss&#xD;
  &#xD;
            6. Participants with severe impairment of vision/ blindness&#xD;
  &#xD;
            7. Participants who require a legally authorized representative (LAR) or lack the&#xD;
               capacity to consent for themselves&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>50 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Vineet Punia, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>The Cleveland Clinic</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Suman Kundu, MBA</last_name>
      <phone>216 554 7036</phone>
      <email>kundus@ccf.org</email>
    </overall_contact>
    <location>
      <facility>
        <name>Cleveland Clinic</name>
        <address>
          <city>Cleveland</city>
          <state>Ohio</state>
          <zip>44195</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Vineet Punia, MD</last_name>
        <phone>216-379-4790</phone>
        <email>PUNIAV@ccf.org</email>
      </contact>
      <contact_backup>
        <last_name>Suman Kundu, MBA</last_name>
        <phone>216 554 7036</phone>
        <email>kundus@ccf.org</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <link>
      <url>https://my.clevelandclinic.org/departments/neurological/research-innovations/brain-study.</url>
      <description>Cleveland Clinic Brain Study 2022</description>
    </link>
    <link>
      <url>https://newsroom.clevelandclinic.org/2022/03/01/cleveland-clinic-launches-first-of-its-kind-study-to-assess-impact-of-lifestyle-interventions-to-control-epileptic-seizures/.</url>
      <description>Reale A. Cleveland Clinic Launches First-of-its-Kind Study to Assess Impact of Lifestyle Interventions to Control Epileptic Seizures 2022 [cited 2022].</description>
    </link>
    <link>
      <url>https://newsroom.clevelandclinic.org/2021/10/07/cleveland-clinic-and-brooks-automation-open-state-of-the-art-biorepository-in-fairfax-neighborhood/.</url>
      <description>Reale A. Cleveland Clinic and Brooks Automation Open State-of-the-Art BioRepository in Fairfax Neighborhood 2021 [cited 2022].</description>
    </link>
    <reference>
      <citation>Kivipelto M, Mangialasche F, Ngandu T. Lifestyle interventions to prevent cognitive impairment, dementia and Alzheimer disease. Nat Rev Neurol. 2018 Nov;14(11):653-666. doi: 10.1038/s41582-018-0070-3.</citation>
      <PMID>30291317</PMID>
    </reference>
    <reference>
      <citation>Marcason W. What Are the Components to the MIND Diet? J Acad Nutr Diet. 2015 Oct;115(10):1744. doi: 10.1016/j.jand.2015.08.002. No abstract available.</citation>
      <PMID>26407649</PMID>
    </reference>
    <reference>
      <citation>Morris MC, Tangney CC, Wang Y, Sacks FM, Barnes LL, Bennett DA, Aggarwal NT. MIND diet slows cognitive decline with aging. Alzheimers Dement. 2015 Sep;11(9):1015-22. doi: 10.1016/j.jalz.2015.04.011. Epub 2015 Jun 15.</citation>
      <PMID>26086182</PMID>
    </reference>
    <reference>
      <citation>Dhana K, James BD, Agarwal P, Aggarwal NT, Cherian LJ, Leurgans SE, Barnes LL, Bennett DA, Schneider JA. MIND Diet, Common Brain Pathologies, and Cognition in Community-Dwelling Older Adults. J Alzheimers Dis. 2021;83(2):683-692. doi: 10.3233/JAD-210107.</citation>
      <PMID>34334393</PMID>
    </reference>
    <reference>
      <citation>Jin B, Krishnan B, Adler S, Wagstyl K, Hu W, Jones S, Najm I, Alexopoulos A, Zhang K, Zhang J, Ding M, Wang S; Pediatric Imaging, Neurocognition, and Genetics Study; Wang ZI. Automated detection of focal cortical dysplasia type II with surface-based magnetic resonance imaging postprocessing and machine learning. Epilepsia. 2018 May;59(5):982-992. doi: 10.1111/epi.14064. Epub 2018 Apr 10.</citation>
      <PMID>29637549</PMID>
    </reference>
    <reference>
      <citation>Panda A, Mehta BB, Coppo S, Jiang Y, Ma D, Seiberlich N, Griswold MA, Gulani V. Magnetic Resonance Fingerprinting-An Overview. Curr Opin Biomed Eng. 2017 Sep;3:56-66. doi: 10.1016/j.cobme.2017.11.001.</citation>
      <PMID>29868647</PMID>
    </reference>
    <reference>
      <citation>Wik L, Nordberg N, Broberg J, Bjorkesten J, Assarsson E, Henriksson S, Grundberg I, Pettersson E, Westerberg C, Liljeroth E, Falck A, Lundberg M. Proximity Extension Assay in Combination with Next-Generation Sequencing for High-throughput Proteome-wide Analysis. Mol Cell Proteomics. 2021;20:100168. doi: 10.1016/j.mcpro.2021.100168. Epub 2021 Oct 27.</citation>
      <PMID>34715355</PMID>
    </reference>
    <reference>
      <citation>Ngandu T, Lehtisalo J, Solomon A, Levalahti E, Ahtiluoto S, Antikainen R, Backman L, Hanninen T, Jula A, Laatikainen T, Lindstrom J, Mangialasche F, Paajanen T, Pajala S, Peltonen M, Rauramaa R, Stigsdotter-Neely A, Strandberg T, Tuomilehto J, Soininen H, Kivipelto M. A 2 year multidomain intervention of diet, exercise, cognitive training, and vascular risk monitoring versus control to prevent cognitive decline in at-risk elderly people (FINGER): a randomised controlled trial. Lancet. 2015 Jun 6;385(9984):2255-63. doi: 10.1016/S0140-6736(15)60461-5. Epub 2015 Mar 12.</citation>
      <PMID>25771249</PMID>
    </reference>
    <reference>
      <citation>Moll van Charante EP, Richard E, Eurelings LS, van Dalen JW, Ligthart SA, van Bussel EF, Hoevenaar-Blom MP, Vermeulen M, van Gool WA. Effectiveness of a 6-year multidomain vascular care intervention to prevent dementia (preDIVA): a cluster-randomised controlled trial. Lancet. 2016 Aug 20;388(10046):797-805. doi: 10.1016/S0140-6736(16)30950-3. Epub 2016 Jul 26.</citation>
      <PMID>27474376</PMID>
    </reference>
    <reference>
      <citation>Andrieu S, Guyonnet S, Coley N, Cantet C, Bonnefoy M, Bordes S, Bories L, Cufi MN, Dantoine T, Dartigues JF, Desclaux F, Gabelle A, Gasnier Y, Pesce A, Sudres K, Touchon J, Robert P, Rouaud O, Legrand P, Payoux P, Caubere JP, Weiner M, Carrie I, Ousset PJ, Vellas B; MAPT Study Group. Effect of long-term omega 3 polyunsaturated fatty acid supplementation with or without multidomain intervention on cognitive function in elderly adults with memory complaints (MAPT): a randomised, placebo-controlled trial. Lancet Neurol. 2017 May;16(5):377-389. doi: 10.1016/S1474-4422(17)30040-6. Epub 2017 Mar 27.</citation>
      <PMID>28359749</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 2, 2023</study_first_submitted>
    <study_first_submitted_qc>August 2, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 9, 2023</study_first_posted>
    <last_update_submitted>August 2, 2023</last_update_submitted>
    <last_update_submitted_qc>August 2, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 9, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>The Cleveland Clinic</investigator_affiliation>
      <investigator_full_name>Vineet Punia MD</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <keyword>Dementia</keyword>
    <keyword>Parkinson's disease</keyword>
    <keyword>Stroke</keyword>
    <keyword>Multiple sclerosis</keyword>
    <keyword>Epilepsy</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Nervous System Diseases</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05984056
  org study id: 22-941
  nct id: NCT05984056
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This clinical trial aims to test the impact of multidisciplinary lifestyle interventions
        (MLI) in neurologically healthy but at-risk individuals. It aims to find out:
  
          -  if giving four different kinds of lifestyle intervention and education slows down or
             reverses the expression of neurological disorder or their biomarkers.
  
          -  new biomarkers that either help in the early detection of neurological disease or
             identify the impact of various lifestyle interventions combined.
  
        Participants will be randomized to the intervention or observation arm. Various biological
        samples and tests, along with survey questionnaires, will be performed at the time of
        entering the study, at 12 weeks after enrollment, and then at the end of the study at 12
        months.
  
          -  Intervention arm: Participants will receive weekly, instructor-led intervention sessions
             (virtual group sessions) for 12 weeks. After the 12-week mark, participants will be
             encouraged to practice what they learned for nine more months.
  
          -  Observation arm: The intervention group will be compared to another group that did not
             get the intervention
  In this prospective, controlled, randomized study, investigators will enroll neurologically
        healthy but at-risk individuals (defined based on the pre-defined, disease-specific criteria
        described below in the "Eligibility" section) to assess the effectiveness of
        multidisciplinary lifestyle interventions (MLI, which include brain health training, yoga,
        music therapy, and MINDS diet education) on delaying, preventing, or reversing the
        progressive expression of known and novel neurological disorder biomarkers.
  
        The study team will accomplish the abovementioned objectives by comparing 200 participants
        randomly assigned to the MLI arm (12 weekly instructor-led virtual group sessions followed by
        nine months of self-practice) or the control arm. All participants (including those enrolled
        in the control arm) will receive the MIND Study Activity Survey every two weeks during this
        first 12-week period.
  
        Participants will undergo neuroimaging, neuropsychology, and neurophysiology testing and
        provide biosamples for genomic, proteomic, and metabolomic analysis along with various survey
        questionnaires at 3-time points: study enrollment, at the 12-week mark, and at the end of the
        study (12-month).
  
        The primary outcome of the study is "pathology progression," which will be considered
        positive when the known biomarker used for initial participant selection increases over the
        study period. Rest will be considered as not showing "pathology progression." Various
        biomarkers collected using the abovementioned tests will be compared within and between the
        intervention and observation groups, and their correlation to pathology progression will be
        analyzed. This longitudinal, correlational testing will help this exploratory study reveal
        potential novel biomarkers of early neurological disorder and the ones that show the impact
        of MLI.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Prevention
  masking: None (Open Label)
  measure: Pathology progression
  time frame: 12 months
  description: At the time of study completion, a participant will be considered to show "Pathology progression" if they fulfill either of the two conditions:
  Clinically diagnosed with any of the above five conditions
  Show the following changes compared to the baseline:
  Stroke: Asymptomatic cortical infarct or further increase in white matter disease MRI changes
  Epilepsy: Increase in burden (per hour) of Spikes/Sharp Waves/Polyspikes or electrographic seizure on EEG
  Movement Disorder: >4 points increase on modified Unified Parkinson's Disease Rating Scale (UPDRS) administered remotely
  Dementia: Increase in number of domain testing ≤ 1.5 SD or drop in scores < 2SD
  Multiple Sclerosis (MS): Increase in the number of MRI lesions or volume of existing lesions
  measure: Quality of Life in Neurological Disorders (Neuro QoL)
  time frame: 12 months
  description: Neuro-QOL uses a 5-point scale for scoring items, with questions ranging from least (1) to most (5) Neuro-QOL uses a T score with a mean of 50 and SD of 10 High scores indicate worse or undesirable, self-reported health.
  measure: PHQ8 (Patient Health Questionnaire)
  time frame: 12 months
  description: It is an eight-item questionnaire used to screen for and assess the severity of depression. The PHQ-8 total score ranges from 0 to 24. A score of 0 to 4 indicates no depression, 5 to 9 indicates mild depression, 10 to 14 indicates moderate depression, 15 to 19 indicates moderately severe depression and 20 or higher indicates severe depression. A score of 10 or greater is considered major depression, and 20 or more is severe major depression.
  measure: Generalized Anxiety Disorder Questionnaire-7 (GAD-7)
  time frame: 12 months
  description: A screening instrument used to detect anxiety symptoms. The total score for the seven items in the GAD-7 ranges from 0 to 21. The scores are calculated by assigning scores of 0, 1, 2, and 3 to the response categories of "not at all," "several days," "more than half the days," and "nearly every day".
  The scores are interpreted as follows:
  0-4: Minimal anxiety 5-9: Mild anxiety 10-14: Moderate anxiety 15 or greater: Severe anxiety 6-10: Moderate 11-15: Moderately severe anxiety
  Scores above 10 are considered to be in the clinical range.
  measure: General Self-Efficacy Scale (GSE)
  time frame: 12 months
  description: The GSE is a 10-item psychometric scale that assesses optimistic self-beliefs to cope with difficult demands in life (coping skills). The minimum score for GSE is 10, and the maximum is 40.
  The higher the score, the greater the individual's generalized self-efficacy belief.
  measure: International Physical Activity Questionnaire (IPAQ)
  time frame: 12 months
  description: IPAQ is a well-developed and widely-used instrument to measure physical activity in adults.
  The IPAQ scoring protocol assigns the following MET (minutes a week) values to walking, moderate, and vigorous-intensity activity: 3.3 METs, 4.0 METs, and 8.0 METs, respectively. To get a continuous variable score from the IPAQ, you can consider walking to be 3.3 METS, moderate physical activity to be 4 METS, and vigorous physical activity to be 8 METS.
  Overall score: Excellent test-retest reliability (ICC = 0.81) Physical activity: Excellent test-retest reliability (ICC = 0.84-1.00) Sitting: Adequate test-retest reliability (ICC = 0.70)
  measure: Perceived Stress Scale (PSS-10)
  time frame: 12 months
  description: The Perceived Stress Scale (PSS) is a 10-item questionnaire that evaluates participants' self-reported amount of stress by assessing their thoughts and feelings in the previous month. Each question is scored from 0 (never) to 5 (very often), with a total possible score range of 0 to 40.
  Higher scores indicate a higher level of stress.
  Here are some cut-off scores for the PSS:
  0-13: low stress 14-26: moderate stress 27-40: high perceived stress 14 and 27: cut-off scores for moderate and high perceived stress, respectively The estimated minimal clinically important difference for the PSS-10 is 11 points
  measure: Pittsburgh Sleep Quality Index (PSQI)
  time frame: 12 months
  description: PSQI is a questionnaire that assesses sleep quality and disturbances and has a global score that ranges from 0 to 21 points.
  The minimum score is 0, considered better, and the maximum score is 3, considered worse.
  The global score is calculated by adding up the average scores of seven factors.
  Higher scores indicate worse sleep quality. The developers of the PSQI suggest a cut-off score of 5 for the global scale, as it correctly identified 88.5% of the patient group in their validation study.
  measure: Patient-Reported Outcomes Measurement Information System (PROMIS)
  time frame: 12 months
  description: PROMIS is a system of measures that evaluates and monitors adults' physical, mental, and social health.
  PROMIS scores range from 36.3 to 82.7, with higher scores indicating worse outcome.
  arm group label: Intervention
  arm group type: Experimental
  description: Multidisciplinary lifestyle interventions will be provided weekly for 12 weeks after enrollment.
  arm group label: Control
  arm group type: No Intervention
  description: No intervention. Periodic check-ups will be performed during the first 12 weeks, followed by monthly check-ins like the intervention arm.
  intervention type: Behavioral
  intervention name: Multidisciplinary lifestyle interventions
  description: Multidisciplinary lifestyle interventions (Brain health training, yoga, music therapy and CC-MIND diet education)
  arm group label: Intervention
  criteria: 
  gender: All
  minimum age: 50 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Vineet Punia, MD
  role: Principal Investigator
  affiliation: The Cleveland Clinic
  last name: Suman Kundu, MBA
  phone: 216 554 7036
  email: kundus@ccf.org
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  country: United States
  url: https://my.clevelandclinic.org/departments/neurological/research-innovations/brain-study.
  description: Cleveland Clinic Brain Study 2022
  url: https://newsroom.clevelandclinic.org/2022/03/01/cleveland-clinic-launches-first-of-its-kind-study-to-assess-impact-of-lifestyle-interventions-to-control-epileptic-seizures/.
  description: Reale A. Cleveland Clinic Launches First-of-its-Kind Study to Assess Impact of Lifestyle Interventions to Control Epileptic Seizures 2022 [cited 2022].
  url: https://newsroom.clevelandclinic.org/2021/10/07/cleveland-clinic-and-brooks-automation-open-state-of-the-art-biorepository-in-fairfax-neighborhood/.
  description: Reale A. Cleveland Clinic and Brooks Automation Open State-of-the-Art BioRepository in Fairfax Neighborhood 2021 [cited 2022].
  citation: Kivipelto M, Mangialasche F, Ngandu T. Lifestyle interventions to prevent cognitive impairment, dementia and Alzheimer disease. Nat Rev Neurol. 2018 Nov;14(11):653-666. doi: 10.1038/s41582-018-0070-3.
  PMID: 30291317
  citation: Marcason W. What Are the Components to the MIND Diet? J Acad Nutr Diet. 2015 Oct;115(10):1744. doi: 10.1016/j.jand.2015.08.002. No abstract available.
  PMID: 26407649
  citation: Morris MC, Tangney CC, Wang Y, Sacks FM, Barnes LL, Bennett DA, Aggarwal NT. MIND diet slows cognitive decline with aging. Alzheimers Dement. 2015 Sep;11(9):1015-22. doi: 10.1016/j.jalz.2015.04.011. Epub 2015 Jun 15.
  PMID: 26086182
  citation: Dhana K, James BD, Agarwal P, Aggarwal NT, Cherian LJ, Leurgans SE, Barnes LL, Bennett DA, Schneider JA. MIND Diet, Common Brain Pathologies, and Cognition in Community-Dwelling Older Adults. J Alzheimers Dis. 2021;83(2):683-692. doi: 10.3233/JAD-210107.
  PMID: 34334393
  citation: Jin B, Krishnan B, Adler S, Wagstyl K, Hu W, Jones S, Najm I, Alexopoulos A, Zhang K, Zhang J, Ding M, Wang S; Pediatric Imaging, Neurocognition, and Genetics Study; Wang ZI. Automated detection of focal cortical dysplasia type II with surface-based magnetic resonance imaging postprocessing and machine learning. Epilepsia. 2018 May;59(5):982-992. doi: 10.1111/epi.14064. Epub 2018 Apr 10.
  PMID: 29637549
  citation: Panda A, Mehta BB, Coppo S, Jiang Y, Ma D, Seiberlich N, Griswold MA, Gulani V. Magnetic Resonance Fingerprinting-An Overview. Curr Opin Biomed Eng. 2017 Sep;3:56-66. doi: 10.1016/j.cobme.2017.11.001.
  PMID: 29868647
  citation: Wik L, Nordberg N, Broberg J, Bjorkesten J, Assarsson E, Henriksson S, Grundberg I, Pettersson E, Westerberg C, Liljeroth E, Falck A, Lundberg M. Proximity Extension Assay in Combination with Next-Generation Sequencing for High-throughput Proteome-wide Analysis. Mol Cell Proteomics. 2021;20:100168. doi: 10.1016/j.mcpro.2021.100168. Epub 2021 Oct 27.
  PMID: 34715355
  citation: Ngandu T, Lehtisalo J, Solomon A, Levalahti E, Ahtiluoto S, Antikainen R, Backman L, Hanninen T, Jula A, Laatikainen T, Lindstrom J, Mangialasche F, Paajanen T, Pajala S, Peltonen M, Rauramaa R, Stigsdotter-Neely A, Strandberg T, Tuomilehto J, Soininen H, Kivipelto M. A 2 year multidomain intervention of diet, exercise, cognitive training, and vascular risk monitoring versus control to prevent cognitive decline in at-risk elderly people (FINGER): a randomised controlled trial. Lancet. 2015 Jun 6;385(9984):2255-63. doi: 10.1016/S0140-6736(15)60461-5. Epub 2015 Mar 12.
  PMID: 25771249
  citation: Moll van Charante EP, Richard E, Eurelings LS, van Dalen JW, Ligthart SA, van Bussel EF, Hoevenaar-Blom MP, Vermeulen M, van Gool WA. Effectiveness of a 6-year multidomain vascular care intervention to prevent dementia (preDIVA): a cluster-randomised controlled trial. Lancet. 2016 Aug 20;388(10046):797-805. doi: 10.1016/S0140-6736(16)30950-3. Epub 2016 Jul 26.
  PMID: 27474376
  citation: Andrieu S, Guyonnet S, Coley N, Cantet C, Bonnefoy M, Bordes S, Bories L, Cufi MN, Dantoine T, Dartigues JF, Desclaux F, Gabelle A, Gasnier Y, Pesce A, Sudres K, Touchon J, Robert P, Rouaud O, Legrand P, Payoux P, Caubere JP, Weiner M, Carrie I, Ousset PJ, Vellas B; MAPT Study Group. Effect of long-term omega 3 polyunsaturated fatty acid supplementation with or without multidomain intervention on cognitive function in elderly adults with memory complaints (MAPT): a randomised, placebo-controlled trial. Lancet Neurol. 2017 May;16(5):377-389. doi: 10.1016/S1474-4422(17)30040-6. Epub 2017 Mar 27.
  PMID: 28359749
  responsible party type: Sponsor-Investigator
  investigator affiliation: The Cleveland Clinic
  investigator full name: Vineet Punia MD
  investigator title: Principal Investigator
  mesh term: Nervous System Diseases
  sharing ipd: No