<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/NCT03750409</url>
  </required_header>
  <id_info>
    <org_study_id>018-209</org_study_id>
    <nct_id>NCT03750409</nct_id>
  </id_info>
  <brief_title>Assessing Feasibility of Prolonged Repetitive Near Infrared Light Stimulation in Early to Mid-Stage Dementia</brief_title>
  <official_title>Assessing Feasibility of Prolonged Repetitive Near Infrared Light Stimulation on Cognitive and Behavioral Symptoms in Early to Mid-Stage Dementia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Baylor Research Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Quietmind Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Baylor Research Institute</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 study will gather data to see if infrared and near infrared light frequency can increase&#xD;
      the activity of brain cells and provide support for the cell's ability to repair and protect&#xD;
      themselves against further damage.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Research suggests that impaired regional cerebral blood flow (rCBF) [flow of blood in certain&#xD;
      parts of the brain] plays an important role in dementia. Infrared and near infrared light&#xD;
      frequency has been shown to increase the activity of brain cells and provide support for the&#xD;
      cell's ability to repair and protect themselves against further damage. This study will&#xD;
      evaluate the effects of repeated brief exposure to near infrared light stimulation twice a&#xD;
      day on subjects that have problems such as attention span, working memory, strategies of&#xD;
      learning and remembering, planning, organizing, self-monitoring, inhibition and flexible&#xD;
      thinking for an 8 week period.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">October 15, 2018</start_date>
  <completion_date type="Anticipated">October 15, 2020</completion_date>
  <primary_completion_date type="Anticipated">October 15, 2020</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>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    <masking_description>Double blind</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Memory Score</measure>
    <time_frame>Before first treatment, at 4 weeks and then at 8 weeks.</time_frame>
    <description>Mini Mental State Exam will be performed in beginning of the study (before first treatment), in the middle of the treatment (in 4 weeks) and in the end of treatment (in the end of 8 weeks). This quick assessment will be able to score assessed individuals using 0-30 scoring range. Collected scores will be compared at different time points and any numerical change in score will be evaluated.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog test) test</measure>
    <time_frame>Before first treatment, at 4 weeks and then at 8 weeks.</time_frame>
    <description>ADAS-Cog test will be performed in beginning of the study (before first treatment), in the middle of the treatment (in 4 weeks) and in the end of treatment (in the end of 8 weeks) to measure cognition. This comprehensive test will measure patient's ability of language and memory. Test consist of 11 parts and will help to assess baseline and determine cognitive change over period of treatment using patient's ability to answer questions and given score.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Quantitative Electro Encephalography (QEEG)</measure>
    <time_frame>Before first treatment, at 4 weeks and then at 8 weeks.</time_frame>
    <description>QEEG measurement will be performed in beginning of the study (before first treatment), in the middle of the treatment (in 4 weeks) and in the end of treatment (in the end of 8 weeks). This measurement will use modern analytic software to process activity of the brain during cognitive task in the forms of electrical signals received from the surface of the scalp. Analytical software uses algorithms to assess recorded brain impulses and evaluate brain function, helping to track changes in the brain function due to treatment.&#xD;
Waveforms of EEG being assessed:&#xD;
Delta frequencies (1-4 HZ) are produced during sleep are widespread in the frontal central region. Delta is necessary for sleep and stillness.&#xD;
Theta frequencies (4-8 HZ) are associated with selective attention, retrieving newly learned information, and preceding sleep. Theta aids creativity and problem solving.&#xD;
Alpha frequencies (8-12 HZ) appear in the posterior when the eyes are closed. It is associated with idling and</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Mild to Moderate Dementia</condition>
  <arm_group>
    <arm_group_label>Helmet Active Device</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients will be randomized 2:1 ratio to receive either the helmet active device or the helmet sham matched device. EACH device will be delivered with a highly visible tag with either an 'A' or 'B' respective to the study group the patient was randomized to.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Helmet Sham</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Patients will be randomized 2:1 ratio to receive either the helmet active device or the helmet sham matched device. EACH device will be delivered with a highly visible tag with either an 'A' or 'B' respective to the study group the patient was randomized to.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Helmet</intervention_name>
    <description>The portable device covers the head and weighs about 3.5 lb., and is made of light-weight, durable plastic, it is placed on the head with eye panels facing forward. Elastic straps holding the arrays together easily expand to conform to each subjects' head. Patients may notice slight warming of scalp after usage. This warming effect is similar to wearing a regular motorcycle helmet for a similar duration.</description>
    <arm_group_label>Helmet Active Device</arm_group_label>
    <arm_group_label>Helmet Sham</arm_group_label>
    <other_name>Photobiomodulation device</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Aged 50-85 years with an independently provided diagnosis of dementia, probable&#xD;
             Alzheimer's type.&#xD;
&#xD;
          -  Dementia symptoms not greater than early to mid-stage dementia&#xD;
&#xD;
          -  Generally healthy as indicated by recent physical examination within the last 6 months&#xD;
&#xD;
          -  If labs are available within the last 6 months, renal function, hepatic function,&#xD;
             cardiac function should be normal&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Diagnosed actively growing intracranial pathology (tumors etc.)&#xD;
&#xD;
          -  Misusing illegal substances or alcohol&#xD;
&#xD;
          -  Previous history of stroke&#xD;
&#xD;
          -  History of aggression or violence&#xD;
&#xD;
          -  History of major psychiatric illness&#xD;
&#xD;
          -  No underlying CNS pathology (confined to tumor, epilepsy only)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jason H Huang, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Baylor Scott and White Healthcare</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Marvin H Berman, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Quiet Mind Foundation</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Quietmind Foundation</name>
      <address>
        <city>Elkins Park</city>
        <state>Pennsylvania</state>
        <zip>19027</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Baylor Scott and White Medical Center, Temple</name>
      <address>
        <city>Temple</city>
        <state>Texas</state>
        <zip>76508</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>October 16, 2018</study_first_submitted>
  <study_first_submitted_qc>November 20, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 23, 2018</study_first_posted>
  <last_update_submitted>August 18, 2020</last_update_submitted>
  <last_update_submitted_qc>August 18, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 19, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>dementia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dementia</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/NCT03750409
org study id: 018-209
nct id: NCT03750409
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study will gather data to see if infrared and near infrared light frequency can increase
      the activity of brain cells and provide support for the cell's ability to repair and protect
      themselves against further damage.
Research suggests that impaired regional cerebral blood flow (rCBF) [flow of blood in certain
      parts of the brain] plays an important role in dementia. Infrared and near infrared light
      frequency has been shown to increase the activity of brain cells and provide support for the
      cell's ability to repair and protect themselves against further damage. This study will
      evaluate the effects of repeated brief exposure to near infrared light stimulation twice a
      day on subjects that have problems such as attention span, working memory, strategies of
      learning and remembering, planning, organizing, self-monitoring, inhibition and flexible
      thinking for an 8 week period.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
masking description: Double blind
measure: Memory Score
time frame: Before first treatment, at 4 weeks and then at 8 weeks.
description: Mini Mental State Exam will be performed in beginning of the study (before first treatment), in the middle of the treatment (in 4 weeks) and in the end of treatment (in the end of 8 weeks). This quick assessment will be able to score assessed individuals using 0-30 scoring range. Collected scores will be compared at different time points and any numerical change in score will be evaluated.
measure: Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog test) test
time frame: Before first treatment, at 4 weeks and then at 8 weeks.
description: ADAS-Cog test will be performed in beginning of the study (before first treatment), in the middle of the treatment (in 4 weeks) and in the end of treatment (in the end of 8 weeks) to measure cognition. This comprehensive test will measure patient's ability of language and memory. Test consist of 11 parts and will help to assess baseline and determine cognitive change over period of treatment using patient's ability to answer questions and given score.
measure: Quantitative Electro Encephalography (QEEG)
time frame: Before first treatment, at 4 weeks and then at 8 weeks.
description: QEEG measurement will be performed in beginning of the study (before first treatment), in the middle of the treatment (in 4 weeks) and in the end of treatment (in the end of 8 weeks). This measurement will use modern analytic software to process activity of the brain during cognitive task in the forms of electrical signals received from the surface of the scalp. Analytical software uses algorithms to assess recorded brain impulses and evaluate brain function, helping to track changes in the brain function due to treatment.
Waveforms of EEG being assessed:
Delta frequencies (1-4 HZ) are produced during sleep are widespread in the frontal central region. Delta is necessary for sleep and stillness.
Theta frequencies (4-8 HZ) are associated with selective attention, retrieving newly learned information, and preceding sleep. Theta aids creativity and problem solving.
Alpha frequencies (8-12 HZ) appear in the posterior when the eyes are closed. It is associated with idling and
arm group label: Helmet Active Device
arm group type: Active Comparator
description: Patients will be randomized 2:1 ratio to receive either the helmet active device or the helmet sham matched device. EACH device will be delivered with a highly visible tag with either an 'A' or 'B' respective to the study group the patient was randomized to.
arm group label: Helmet Sham
arm group type: Sham Comparator
description: Patients will be randomized 2:1 ratio to receive either the helmet active device or the helmet sham matched device. EACH device will be delivered with a highly visible tag with either an 'A' or 'B' respective to the study group the patient was randomized to.
intervention type: Device
intervention name: Helmet
description: The portable device covers the head and weighs about 3.5 lb., and is made of light-weight, durable plastic, it is placed on the head with eye panels facing forward. Elastic straps holding the arrays together easily expand to conform to each subjects' head. Patients may notice slight warming of scalp after usage. This warming effect is similar to wearing a regular motorcycle helmet for a similar duration.
arm group label: Helmet Active Device
arm group label: Helmet Sham
other name: Photobiomodulation device
criteria: 
gender: All
minimum age: 50 Years
maximum age: 85 Years
healthy volunteers: No
last name: Jason H Huang, MD
role: Principal Investigator
affiliation: Baylor Scott and White Healthcare
last name: Marvin H Berman, PhD
role: Principal Investigator
affiliation: Quiet Mind Foundation
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Dementia
sharing ipd: No