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/NCT05996575</url>
    </required_header>
    <id_info>
      <org_study_id>KER2023-3-IMPACT</org_study_id>
      <nct_id>NCT05996575</nct_id>
    </id_info>
    <brief_title>Investigating Mild Cognitive Impairment in Patients And Controls With TD-fNIRS</brief_title>
    <acronym>IMPACT</acronym>
    <official_title>IMPACT: Investigating Mild Cognitive Impairment in Patients And Controls With TD-fNIRS</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Kernel</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Kernel</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>
        The goal of the proposed observational, multi-site study is to use fNIRS neurophysiological&#xD;
        data recorded during a battery of tasks to detect MCI within a cohort consisting of patients&#xD;
        and age-matched healthy controls. Furthermore, the investigators aim to explore whether they&#xD;
        can measure the severity of MCI symptoms in the patient population. If successful, this&#xD;
        approach enables clinicians to track the disease at its source-the brain; possibly allowing&#xD;
        for earlier detection of MCI and its progression, and ultimately more efficient&#xD;
        interventions.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 25, 2023</start_date>
    <completion_date type="Anticipated">December 2024</completion_date>
    <primary_completion_date type="Anticipated">July 2024</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Cross-Sectional</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Brain hemodynamic activity with TD-fNIRS</measure>
      <time_frame>About 1 hour during the study visit</time_frame>
      <description>This includes changes in the concentration of oxygenated and deoxygenated hemoglobin as measured by the change in light absorption.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Optical properties of the brain with TD-fNIRS</measure>
      <time_frame>About 1 hour during the study visit</time_frame>
      <description>This measures how much light is absorbed at different points on the head.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Physiological features with TD-fNIRS</measure>
      <time_frame>About 1 hour during the study visit</time_frame>
      <description>This includes cardiac measures, such as heart rate (HR) and heart rate variability (HRV).</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Mini-Mental State Evaluation (MMSE)</measure>
      <time_frame>Within 6 months of the study visit</time_frame>
      <description>Clinician-administered screening tool used to systematically and thoroughly assess mental status through five areas of cognitive function: orientation, registration, attention and calculation, recall, and language. Patient cohort only. Scores range between 0-30. A score of 25 or higher is classed as normal. If the score is below 24, the result is usually considered to be abnormal, indicating possible cognitive impairment.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Mini-Cog</measure>
      <time_frame>About 30 minutes during the study visit</time_frame>
      <description>A fast and simple screening test to help detect cognitive impairment in its early stages that will be used to confirm normal cognitive function in the control group. Healthy control cohort only. Scores range between 0-5. Participants who score 0-2 are considered to indicate higher likelihood of cognitive impairment.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Geriatric Depression Scale (Short Form)</measure>
      <time_frame>About 30 minutes during the study visit</time_frame>
      <description>15-item self report measure of depression in older adults. Scores range between 0-15. Higher scores indicate high severity of depression.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>General Anxiety Disorder</measure>
      <time_frame>About 30 minutes during the study visit</time_frame>
      <description>Seven-item self report measure used to assess participant anxiety. Scores range between 0-21. Higher scores indicate high severity of anxiety.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Apathy Evaluation Scale</measure>
      <time_frame>About 30 minutes during the study visit</time_frame>
      <description>18-item self-rated measure used to assess and quantify emotional, behavioral, and cognitive aspects of apathy. Scores range between 18-72. Higher scores indicate high severity of apathy.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Alzheimer's Disease Cooperative Study Activities of Daily Living for Mild Cognitive Impairment (ADCS ADL-MCI)</measure>
      <time_frame>About 30 minutes during the study visit</time_frame>
      <description>15-item self report measure used to assess performance of activities of daily life. Scores range between 0-45. Higher scores indicate declining cognition.</description>
    </secondary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">100</enrollment>
    <condition>Mild Cognitive Impairment</condition>
    <arm_group>
      <arm_group_label>MCI Patients</arm_group_label>
      <description>Adult participants who are seeking neurological assessments for Mild Cognitive Impairment (MCI) at a participating clinic/study site.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Healthy Controls</arm_group_label>
      <description>Healthy participants without a prior MCI or memory impairment diagnosis.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>fNIRS measurement</intervention_name>
      <description>Kernel Flow2 measurements.</description>
      <arm_group_label>Healthy Controls</arm_group_label>
      <arm_group_label>MCI Patients</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Adult participants seeking neurological assessments for Mild Cognitive Impairment (MCI) at&#xD;
          a participating clinic/study site. A separate cohort of age-matched healthy participants&#xD;
          will be recruited as the control group. The current study, including the acquired data and&#xD;
          participation in the study, has no influence on diagnosis or treatment decisions.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          Patients&#xD;
  &#xD;
            -  Must have a diagnosis of MCI (amnesiac or non-amnesiac) as determined by clinician&#xD;
  &#xD;
            -  Adults (older adults) between the ages of 55-85 years inclusive at time of enrollment&#xD;
  &#xD;
            -  Ability to perform informed consent on their own&#xD;
  &#xD;
            -  Fluent in English (speaking and reading)&#xD;
  &#xD;
          Healthy Controls&#xD;
  &#xD;
            -  Adults (older adults) between the ages of 55-85 years inclusive at time of enrollment&#xD;
  &#xD;
            -  Ability to perform informed consent on their own&#xD;
  &#xD;
            -  Fluent in English (speaking and reading)&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          Patients&#xD;
  &#xD;
            -  Alzheimer's or dementia diagnosis&#xD;
  &#xD;
            -  Current substance or alcohol dependence, and/or alcohol or substance abuse as&#xD;
               determined by CAGE-AID assessment for drug and alcohol abuse. A score of 2 or higher&#xD;
               would result in exclusion.&#xD;
  &#xD;
            -  Has uncorrected major visual or auditory deficits that would prevent them from&#xD;
               completing a study task&#xD;
  &#xD;
            -  Current or recent (in the past 6 months) chemotherapy and/or radiation for any cancer&#xD;
  &#xD;
            -  Major medical illnesses and psychiatric conditions (other than MCI) including:&#xD;
  &#xD;
                 -  Severe/uncontrolled Diabetes, hypertension and hypothyroidism that could pose&#xD;
                    secondary causes of cognitive decline&#xD;
  &#xD;
                 -  Parkinson's disease&#xD;
  &#xD;
                 -  Motor neuron diseases&#xD;
  &#xD;
                 -  Multiple Sclerosis&#xD;
  &#xD;
                 -  Brain Tumor&#xD;
  &#xD;
                 -  Stroke&#xD;
  &#xD;
                 -  Encephalitis&#xD;
  &#xD;
                 -  Meningitis&#xD;
  &#xD;
                 -  Epilepsy&#xD;
  &#xD;
                 -  TBI with serious results (coma, unconscious for &gt;2 hrs, or skull fracture)&#xD;
  &#xD;
                 -  Current serious psychiatric conditions (bipolar disorder, schizophrenia, or&#xD;
                    psychosis)&#xD;
  &#xD;
          Healthy Controls&#xD;
  &#xD;
            -  Prior MCI or memory impairment diagnosis&#xD;
  &#xD;
            -  First-degree relative with dementia or clinically relevant memory problems&#xD;
  &#xD;
            -  Alzheimer's or dementia diagnosis&#xD;
  &#xD;
            -  Current substance or alcohol dependence, and/or alcohol or substance abuse as&#xD;
               determined by CAGE-AID assessment for drug and alcohol abuse. A score of 2 or higher&#xD;
               would result in exclusion.&#xD;
  &#xD;
            -  Has uncorrected major visual or auditory deficits that would prevent them from&#xD;
               completing a study task&#xD;
  &#xD;
            -  Current or recent (in the past 6 months) chemotherapy and/or radiation for any cancer&#xD;
  &#xD;
            -  Major medical illnesses and psychiatric conditions including:&#xD;
  &#xD;
                 -  Severe/uncontrolled Diabetes, hypertension and hypothyroidism that could pose&#xD;
                    secondary causes of cognitive decline&#xD;
  &#xD;
                 -  Parkinson's disease&#xD;
  &#xD;
                 -  Motor neuron diseases&#xD;
  &#xD;
                 -  Multiple Sclerosis&#xD;
  &#xD;
                 -  Brain Tumor&#xD;
  &#xD;
                 -  Stroke&#xD;
  &#xD;
                 -  Encephalitis&#xD;
  &#xD;
                 -  Meningitis&#xD;
  &#xD;
                 -  Epilepsy&#xD;
  &#xD;
                 -  TBI with serious results (coma, unconscious for &gt;2 hrs, or skull fracture)&#xD;
  &#xD;
                 -  Current serious psychiatric conditions (bipolar disorder, schizophrenia, or&#xD;
                    psychosis)&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>55 Years</minimum_age>
      <maximum_age>85 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Katherine Perdue, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Kernel</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Katherine Perdue, PhD</last_name>
      <phone>323-238-9225</phone>
      <email>research@kernel.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Moriah Taylor</last_name>
      <phone>323-238-9225</phone>
      <email>research@kernel.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>The Research Center of Southern California</name>
        <address>
          <city>Carlsbad</city>
          <state>California</state>
          <zip>92011</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>The Research Center of Southern California</name>
        <address>
          <city>Escondido</city>
          <state>California</state>
          <zip>92029</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Kernel</name>
        <address>
          <city>Los Angeles</city>
          <state>California</state>
          <zip>90232</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Moriah Taylor</last_name>
        <phone>323-238-9225</phone>
        <email>research@kernel.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>The Research Center of Southern California</name>
        <address>
          <city>Temecula</city>
          <state>California</state>
          <zip>92592</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 2, 2023</study_first_submitted>
    <study_first_submitted_qc>August 9, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 18, 2023</study_first_posted>
    <last_update_submitted>August 9, 2023</last_update_submitted>
    <last_update_submitted_qc>August 9, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>functional Near Infrared Spectroscopy (fNIRS)</keyword>
    <keyword>Aging</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Cognitive Dysfunction</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</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/NCT05996575
  org study id: KER2023-3-IMPACT
  nct id: NCT05996575
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The goal of the proposed observational, multi-site study is to use fNIRS neurophysiological
        data recorded during a battery of tasks to detect MCI within a cohort consisting of patients
        and age-matched healthy controls. Furthermore, the investigators aim to explore whether they
        can measure the severity of MCI symptoms in the patient population. If successful, this
        approach enables clinicians to track the disease at its source-the brain; possibly allowing
        for earlier detection of MCI and its progression, and ultimately more efficient
        interventions.
  observational model: Cohort
  time perspective: Cross-Sectional
  measure: Brain hemodynamic activity with TD-fNIRS
  time frame: About 1 hour during the study visit
  description: This includes changes in the concentration of oxygenated and deoxygenated hemoglobin as measured by the change in light absorption.
  measure: Optical properties of the brain with TD-fNIRS
  time frame: About 1 hour during the study visit
  description: This measures how much light is absorbed at different points on the head.
  measure: Physiological features with TD-fNIRS
  time frame: About 1 hour during the study visit
  description: This includes cardiac measures, such as heart rate (HR) and heart rate variability (HRV).
  measure: Mini-Mental State Evaluation (MMSE)
  time frame: Within 6 months of the study visit
  description: Clinician-administered screening tool used to systematically and thoroughly assess mental status through five areas of cognitive function: orientation, registration, attention and calculation, recall, and language. Patient cohort only. Scores range between 0-30. A score of 25 or higher is classed as normal. If the score is below 24, the result is usually considered to be abnormal, indicating possible cognitive impairment.
  measure: Mini-Cog
  time frame: About 30 minutes during the study visit
  description: A fast and simple screening test to help detect cognitive impairment in its early stages that will be used to confirm normal cognitive function in the control group. Healthy control cohort only. Scores range between 0-5. Participants who score 0-2 are considered to indicate higher likelihood of cognitive impairment.
  measure: Geriatric Depression Scale (Short Form)
  time frame: About 30 minutes during the study visit
  description: 15-item self report measure of depression in older adults. Scores range between 0-15. Higher scores indicate high severity of depression.
  measure: General Anxiety Disorder
  time frame: About 30 minutes during the study visit
  description: Seven-item self report measure used to assess participant anxiety. Scores range between 0-21. Higher scores indicate high severity of anxiety.
  measure: Apathy Evaluation Scale
  time frame: About 30 minutes during the study visit
  description: 18-item self-rated measure used to assess and quantify emotional, behavioral, and cognitive aspects of apathy. Scores range between 18-72. Higher scores indicate high severity of apathy.
  measure: Alzheimer's Disease Cooperative Study Activities of Daily Living for Mild Cognitive Impairment (ADCS ADL-MCI)
  time frame: About 30 minutes during the study visit
  description: 15-item self report measure used to assess performance of activities of daily life. Scores range between 0-45. Higher scores indicate declining cognition.
  arm group label: MCI Patients
  description: Adult participants who are seeking neurological assessments for Mild Cognitive Impairment (MCI) at a participating clinic/study site.
  arm group label: Healthy Controls
  description: Healthy participants without a prior MCI or memory impairment diagnosis.
  intervention type: Other
  intervention name: fNIRS measurement
  description: Kernel Flow2 measurements.
  arm group label: Healthy Controls
  arm group label: MCI Patients
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 55 Years
  maximum age: 85 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Katherine Perdue, PhD
  role: Principal Investigator
  affiliation: Kernel
  last name: Katherine Perdue, PhD
  phone: 323-238-9225
  email: research@kernel.com
  last name: Moriah Taylor
  phone: 323-238-9225
  email: research@kernel.com
  facility: 
  status: Recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  country: United States
  responsible party type: Sponsor
  mesh term: Cognitive Dysfunction
  sharing ipd: Undecided