<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/NCT02233413</url>
  </required_header>
  <id_info>
    <org_study_id>2013P000430</org_study_id>
    <secondary_id>W81XWH-13-2-0067 CDMRP</secondary_id>
    <nct_id>NCT02233413</nct_id>
  </id_info>
  <brief_title>Light Therapy for Moderate Traumatic Brain Injury</brief_title>
  <acronym>LLLT for TBI</acronym>
  <official_title>Low Level Light Therapy (LLLT) With Near Infrared Light Emitting Diodes in Patients With Moderate Traumatic Brain Injury (TBI)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Massachusetts General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Massachusetts General Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this research study is to find out if a specialized helmet that provides low&#xD;
      levels of near infrared light, also known as low-level light therapy (LLLT) has any effect on&#xD;
      the recovery of people who have recently (within 72h) suffered a moderate traumatic brain&#xD;
      injury (TBI).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The specific aim of this pilot study is to determine the feasibility of using the LLLT helmet&#xD;
      in patients with moderate TBI and to quantify the response to LLLT using magnetic resonance&#xD;
      (MR) and clinical outcome measures. We hypothesize that we will be able to quantify the&#xD;
      response to LLLT through MR imaging and clinical outcome measures.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 2014</start_date>
  <completion_date type="Actual">July 2020</completion_date>
  <primary_completion_date type="Actual">July 31, 2019</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>Other</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Safety and Feasibility of Applying Light Therapy After Moderate TBI</measure>
    <time_frame>up to seven days after enrollment</time_frame>
    <description>Number of subjects to successfully complete light therapy without serious unanticipated adverse events related to application of the device.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Neuroreactivity of Light Therapy to the Injured Brain Based on MRI Using the Fazekas Scale for Periventricular White Matter (PVWM)</measure>
    <time_frame>up to 3 months after treatment</time_frame>
    <description>The presence of chronic white matter disease was evaluated using Fazekas scale. The scale divides the white matter in periventricular and deep white matter, and each region is given a grade depending on the size and confluence of lesions.&#xD;
periventricular white matter (PVWM). 0 = absent&#xD;
= &quot;caps&quot; or pencil-thin lining&#xD;
= smooth &quot;halo&quot;&#xD;
= irregular periventricular signal extending into the deep white matter&#xD;
A neuroradiologist evaluated the 3D T2-SPACE-FLAIR images to detect the presence of T2 hyperintensities and their degree (0: absent; 1: mild; 2: moderate; and 3: severe) for PVWM. Higher values represent a worse outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neuroreactivity of Light Therapy to the Injured Brain Based on MRI Using the Fazekas Scale for Deep White Matter (DWM)</measure>
    <time_frame>up to 3 months after treatment</time_frame>
    <description>The presence of chronic white matter disease was evaluated using Fazekas scale. The scale divides the white matter in periventricular and deep white matter, and each region is given a grade depending on the size and confluence of lesions.&#xD;
deep white matter (DWM) 0 = absent&#xD;
= punctate foci&#xD;
= beginning confluence&#xD;
= large confluent areas&#xD;
A neuroradiologist evaluated the 3D T2-SPACE-FLAIR images to detect the presence of T2 hyperintensities and their degree (0: absent; 1: mild; 2: moderate; and 3: severe) for DWM. Higher values represent a worse outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neuroreactivity of Light Therapy to the Injured Brain Based on Neurcognitive Function</measure>
    <time_frame>RPQ scores were collected at approx 72 hours, 14 days, 3 months, and 6 months and the mean was calculated for the values reported.</time_frame>
    <description>RPQ is a 16 item self-assessment questionnaire completed via an in-person or phone interview. Each item in the questionnaire is assessed on a 5-point scale ranging from 0 (no problem) - 4 (severe problem). The questions are grouped in two non-overlapping sets: the RPQ-3 includes early, objective, physical symptoms, and the RPQ-13 group includes later, more cognitive and behavioral symptoms. The RPQ-3 encompasses headache, dizziness, and nausea/vomiting. The RPQ-13 includes questions evaluating noise sensitivity, sleep disturbance, fatigue, irritability, depressed mood, forgetfulness, poor concentration, longer thinking time, blurred vision, light sensitivity, double vision, and restlessness. The RPQ-3 ranges from 0 - 12 (best to worst) and RPQ-13 ranges from 0 - 52 (best to worst). RPQ Total is the theoretical max/min RPQ score with a combined possible score ranging from 0-64 (best to worst). The outcome measures are</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">68</enrollment>
  <condition>Moderate Traumatic Brain Injury (TBI)</condition>
  <arm_group>
    <arm_group_label>Non-active LLLT helmet application</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>A helmet containing near infrared LED's (LLLT helmet) will be applied to the head, however, the LEDs will not be turned on / activated.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Active LLLT helmet application</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>A helmet containing near infrared LEDs (LLLT helmet) will be applied and the LEDs will be turned on/activated</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Active LLLT helmet application</intervention_name>
    <description>LED helmet applied with light activated</description>
    <arm_group_label>Active LLLT helmet application</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Non-active LLLT helmet application</intervention_name>
    <description>LED helmet applied without light activated</description>
    <arm_group_label>Non-active LLLT helmet application</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  At least 18 years old;&#xD;
&#xD;
          -  Injury within 72 hours at the time of consent;&#xD;
&#xD;
          -  Head injury requiring hospital admission;&#xD;
&#xD;
          -  A Glasgow Coma Scale (GCS) score of 9-12 or 13-15 with abnormal imaging.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Need for emergency neurosurgical intervention (including placement of intracranial&#xD;
             pressure monitoring devices or drainage catheters);&#xD;
&#xD;
          -  Hemodynamic instability as determined by the clinician;&#xD;
&#xD;
          -  History of any of the following: (i) brain tumor; (ii) prior TBI occurring within the&#xD;
             past year and requiring hospital admission; (iii) a new diagnosis within the past year&#xD;
             of either stroke or epilepsy; (iv) an established diagnosis of any of the following&#xD;
             neurodegenerative diseases: Alzheimer's, Picks, Parkinson's, Lewy body dementia,&#xD;
             Huntington's, amytropic lateral sclerosis, spinocerebellar ataxia, vascular dementia,&#xD;
             HIZ-associated dementia, dementia due to metabolic causes (Addison, Cushing,&#xD;
             hypothyroidism, renal failure, prophyrias, Wilson, mitochondrial diseases,&#xD;
             Wernicke-Korsakoff syndrome, and dementia of unknown etiology.&#xD;
&#xD;
          -  Pregnancy (all women of child-bearing age will need to have a negative pregnancy test&#xD;
             prior to the start of the interventional portion of the study);&#xD;
&#xD;
          -  Electrical implants such as cardiac pacemakers or perfusion pumps;&#xD;
&#xD;
          -  Ferromagnetic implants such as aneurysm clips, surgical clips, prostheses, artificial&#xD;
             hearts, valves with steel parts, metal fragments, shrapnel, tattoos near the eye, or&#xD;
             steel implants, or any other contra-indications to MRI.&#xD;
&#xD;
          -  Clinical determination that subject cannot undergo MRI&#xD;
&#xD;
          -  Breastfeeding&#xD;
&#xD;
          -  Unstable cervical fractures&#xD;
&#xD;
          -  Scalp lacerations or surgical wounds severe enough to preclude safe application of&#xD;
             device&#xD;
&#xD;
          -  Unreliable to follow up&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Rajiv Gupta, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Massachusetts General Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Benjamin Vakoc, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Massachussetts General Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Massachusetts General Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>June 5, 2014</study_first_submitted>
  <study_first_submitted_qc>September 3, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 8, 2014</study_first_posted>
  <results_first_submitted>July 31, 2020</results_first_submitted>
  <results_first_submitted_qc>November 10, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">December 3, 2020</results_first_posted>
  <last_update_submitted>November 10, 2020</last_update_submitted>
  <last_update_submitted_qc>November 10, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">December 3, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Massachusetts General Hospital</investigator_affiliation>
    <investigator_full_name>Rajiv Gupta</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Traumatic brain injury</keyword>
  <keyword>TBI</keyword>
  <keyword>Low-level light therapy</keyword>
  <keyword>LLLT</keyword>
  <keyword>LLLT helmet</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Brain Injuries</mesh_term>
    <mesh_term>Brain Injuries, Traumatic</mesh_term>
    <mesh_term>Wounds and Injuries</mesh_term>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>July 13, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/13/NCT02233413/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>June 26, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/13/NCT02233413/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Non-active LLLT Helmet Application</title>
          <description>A helmet containing near infrared LED's (LLLT helmet) will be applied to the head, however, the LEDs will not be turned on / activated.&#xD;
Non-active LLLT helmet application: LED helmet applied without light activated</description>
        </group>
        <group group_id="P2">
          <title>Active LLLT Helmet Application</title>
          <description>A helmet containing near infrared LEDs (LLLT helmet) will be applied and the LEDs will be turned on/activated&#xD;
Active LLLT helmet application: LED helmet applied with light activated</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="35"/>
                <participants group_id="P2" count="33"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="24"/>
                <participants group_id="P2" count="19"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="11"/>
                <participants group_id="P2" count="14"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="9"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="5"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Non-active LLLT Helmet Application</title>
          <description>A helmet containing near infrared LED's (LLLT helmet) will be applied to the head, however, the LEDs will not be turned on / activated.&#xD;
Non-active LLLT helmet application: LED helmet applied without light activated</description>
        </group>
        <group group_id="B2">
          <title>Active LLLT Helmet Application</title>
          <description>A helmet containing near infrared LEDs (LLLT helmet) will be applied and the LEDs will be turned on/activated&#xD;
Active LLLT helmet application: LED helmet applied with light activated</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="24"/>
            <count group_id="B2" value="19"/>
            <count group_id="B3" value="43"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="54.00" spread="14.68"/>
                    <measurement group_id="B2" value="46.05" spread="19.93"/>
                    <measurement group_id="B3" value="50.49" spread="17.44"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="21"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                    <measurement group_id="B2" value="16"/>
                    <measurement group_id="B3" value="32"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="33"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Injury Mechanism</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Bike/Motorcycle Accident with Helmet</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Bike/Motorcycle Accident without Helmet</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Fall</title>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="25"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Other</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Pedestrian accident with car/motorcycle/bike</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Restrained Automobile Accident</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unrestrained Automobile Accident</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Violence/assault</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Safety and Feasibility of Applying Light Therapy After Moderate TBI</title>
        <description>Number of subjects to successfully complete light therapy without serious unanticipated adverse events related to application of the device.</description>
        <time_frame>up to seven days after enrollment</time_frame>
        <population>Subjects who completed light or sham treatment and at least one MRI scan. 43 patients completed the study with at least one MRI scan, 19 subjects in the Light treatment group and 24 subjects in the sham treatment group.</population>
        <group_list>
          <group group_id="O1">
            <title>Non-active LLLT Helmet Application</title>
            <description>A helmet containing near infrared LED's (LLLT helmet) will be applied to the head, however, the LEDs will not be turned on / activated.&#xD;
Non-active LLLT helmet application: LED helmet applied without light activated</description>
          </group>
          <group group_id="O2">
            <title>Active LLLT Helmet Application</title>
            <description>A helmet containing near infrared LEDs (LLLT helmet) will be applied and the LEDs will be turned on/activated&#xD;
Active LLLT helmet application: LED helmet applied with light activated</description>
          </group>
        </group_list>
        <measure>
          <title>Safety and Feasibility of Applying Light Therapy After Moderate TBI</title>
          <description>Number of subjects to successfully complete light therapy without serious unanticipated adverse events related to application of the device.</description>
          <population>Subjects who completed light or sham treatment and at least one MRI scan. 43 patients completed the study with at least one MRI scan, 19 subjects in the Light treatment group and 24 subjects in the sham treatment group.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="24"/>
                <count group_id="O2" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24"/>
                    <measurement group_id="O2" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Neuroreactivity of Light Therapy to the Injured Brain Based on MRI Using the Fazekas Scale for Periventricular White Matter (PVWM)</title>
        <description>The presence of chronic white matter disease was evaluated using Fazekas scale. The scale divides the white matter in periventricular and deep white matter, and each region is given a grade depending on the size and confluence of lesions.&#xD;
periventricular white matter (PVWM). 0 = absent&#xD;
= &quot;caps&quot; or pencil-thin lining&#xD;
= smooth &quot;halo&quot;&#xD;
= irregular periventricular signal extending into the deep white matter&#xD;
A neuroradiologist evaluated the 3D T2-SPACE-FLAIR images to detect the presence of T2 hyperintensities and their degree (0: absent; 1: mild; 2: moderate; and 3: severe) for PVWM. Higher values represent a worse outcome.</description>
        <time_frame>up to 3 months after treatment</time_frame>
        <population>Of the 68 patients that were randomized, 28 completed at least one light therapy session. 43 patients completed the study with at least one MRI scan. 19 subjects in the light treatment group and 24 subjects in the sham treatment group. One MRI was deemed low quality and excluded from analysis (19 light treatment / 23 sham)</population>
        <group_list>
          <group group_id="O1">
            <title>Non-active LLLT Helmet Application</title>
            <description>A helmet containing near infrared LED's (LLLT helmet) will be applied to the head, however, the LEDs will not be turned on / activated.&#xD;
Non-active LLLT helmet application: LED helmet applied without light activated</description>
          </group>
          <group group_id="O2">
            <title>Active LLLT Helmet Application</title>
            <description>A helmet containing near infrared LEDs (LLLT helmet) will be applied and the LEDs will be turned on/activated&#xD;
Active LLLT helmet application: LED helmet applied with light activated</description>
          </group>
        </group_list>
        <measure>
          <title>Neuroreactivity of Light Therapy to the Injured Brain Based on MRI Using the Fazekas Scale for Periventricular White Matter (PVWM)</title>
          <description>The presence of chronic white matter disease was evaluated using Fazekas scale. The scale divides the white matter in periventricular and deep white matter, and each region is given a grade depending on the size and confluence of lesions.&#xD;
periventricular white matter (PVWM). 0 = absent&#xD;
= &quot;caps&quot; or pencil-thin lining&#xD;
= smooth &quot;halo&quot;&#xD;
= irregular periventricular signal extending into the deep white matter&#xD;
A neuroradiologist evaluated the 3D T2-SPACE-FLAIR images to detect the presence of T2 hyperintensities and their degree (0: absent; 1: mild; 2: moderate; and 3: severe) for PVWM. Higher values represent a worse outcome.</description>
          <population>Of the 68 patients that were randomized, 28 completed at least one light therapy session. 43 patients completed the study with at least one MRI scan. 19 subjects in the light treatment group and 24 subjects in the sham treatment group. One MRI was deemed low quality and excluded from analysis (19 light treatment / 23 sham)</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="23"/>
                <count group_id="O2" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>PVWM: Absent / &quot;Caps&quot; or pencil-thin lining (1)</title>
                  <measurement_list>
                    <measurement group_id="O1" value="19"/>
                    <measurement group_id="O2" value="18"/>
                  </measurement_list>
                </category>
                <category>
                  <title>PVWM: Smooth &quot;halo&quot; (2)</title>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>PVWM: Irregular periventricular signal (3)</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Neuroreactivity of Light Therapy to the Injured Brain Based on MRI Using the Fazekas Scale for Deep White Matter (DWM)</title>
        <description>The presence of chronic white matter disease was evaluated using Fazekas scale. The scale divides the white matter in periventricular and deep white matter, and each region is given a grade depending on the size and confluence of lesions.&#xD;
deep white matter (DWM) 0 = absent&#xD;
= punctate foci&#xD;
= beginning confluence&#xD;
= large confluent areas&#xD;
A neuroradiologist evaluated the 3D T2-SPACE-FLAIR images to detect the presence of T2 hyperintensities and their degree (0: absent; 1: mild; 2: moderate; and 3: severe) for DWM. Higher values represent a worse outcome.</description>
        <time_frame>up to 3 months after treatment</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Non-active LLLT Helmet Application</title>
            <description>A helmet containing near infrared LED's (LLLT helmet) will be applied to the head, however, the LEDs will not be turned on / activated.&#xD;
Non-active LLLT helmet application: LED helmet applied without light activated</description>
          </group>
          <group group_id="O2">
            <title>Active LLLT Helmet Application</title>
            <description>A helmet containing near infrared LEDs (LLLT helmet) will be applied and the LEDs will be turned on/activated&#xD;
Active LLLT helmet application: LED helmet applied with light activated</description>
          </group>
        </group_list>
        <measure>
          <title>Neuroreactivity of Light Therapy to the Injured Brain Based on MRI Using the Fazekas Scale for Deep White Matter (DWM)</title>
          <description>The presence of chronic white matter disease was evaluated using Fazekas scale. The scale divides the white matter in periventricular and deep white matter, and each region is given a grade depending on the size and confluence of lesions.&#xD;
deep white matter (DWM) 0 = absent&#xD;
= punctate foci&#xD;
= beginning confluence&#xD;
= large confluent areas&#xD;
A neuroradiologist evaluated the 3D T2-SPACE-FLAIR images to detect the presence of T2 hyperintensities and their degree (0: absent; 1: mild; 2: moderate; and 3: severe) for DWM. Higher values represent a worse outcome.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="23"/>
                <count group_id="O2" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>DWM: Absent(0)/Puctuate foci(1)</title>
                  <measurement_list>
                    <measurement group_id="O1" value="19"/>
                    <measurement group_id="O2" value="16"/>
                  </measurement_list>
                </category>
                <category>
                  <title>DWM: Beginning confluence (2)</title>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>DWM: Large confluent areas</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Neuroreactivity of Light Therapy to the Injured Brain Based on Neurcognitive Function</title>
        <description>RPQ is a 16 item self-assessment questionnaire completed via an in-person or phone interview. Each item in the questionnaire is assessed on a 5-point scale ranging from 0 (no problem) - 4 (severe problem). The questions are grouped in two non-overlapping sets: the RPQ-3 includes early, objective, physical symptoms, and the RPQ-13 group includes later, more cognitive and behavioral symptoms. The RPQ-3 encompasses headache, dizziness, and nausea/vomiting. The RPQ-13 includes questions evaluating noise sensitivity, sleep disturbance, fatigue, irritability, depressed mood, forgetfulness, poor concentration, longer thinking time, blurred vision, light sensitivity, double vision, and restlessness. The RPQ-3 ranges from 0 - 12 (best to worst) and RPQ-13 ranges from 0 - 52 (best to worst). RPQ Total is the theoretical max/min RPQ score with a combined possible score ranging from 0-64 (best to worst). The outcome measures are</description>
        <time_frame>RPQ scores were collected at approx 72 hours, 14 days, 3 months, and 6 months and the mean was calculated for the values reported.</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Non-active LLLT Helmet Application</title>
            <description>A helmet containing near infrared LED's (LLLT helmet) will be applied to the head, however, the LEDs will not be turned on / activated.&#xD;
Non-active LLLT helmet application: LED helmet applied without light activated</description>
          </group>
          <group group_id="O2">
            <title>Active LLLT Helmet Application</title>
            <description>A helmet containing near infrared LEDs (LLLT helmet) will be applied and the LEDs will be turned on/activated&#xD;
Active LLLT helmet application: LED helmet applied with light activated</description>
          </group>
        </group_list>
        <measure>
          <title>Neuroreactivity of Light Therapy to the Injured Brain Based on Neurcognitive Function</title>
          <description>RPQ is a 16 item self-assessment questionnaire completed via an in-person or phone interview. Each item in the questionnaire is assessed on a 5-point scale ranging from 0 (no problem) - 4 (severe problem). The questions are grouped in two non-overlapping sets: the RPQ-3 includes early, objective, physical symptoms, and the RPQ-13 group includes later, more cognitive and behavioral symptoms. The RPQ-3 encompasses headache, dizziness, and nausea/vomiting. The RPQ-13 includes questions evaluating noise sensitivity, sleep disturbance, fatigue, irritability, depressed mood, forgetfulness, poor concentration, longer thinking time, blurred vision, light sensitivity, double vision, and restlessness. The RPQ-3 ranges from 0 - 12 (best to worst) and RPQ-13 ranges from 0 - 52 (best to worst). RPQ Total is the theoretical max/min RPQ score with a combined possible score ranging from 0-64 (best to worst). The outcome measures are</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="24"/>
                <count group_id="O2" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>RPQ-3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.55" spread="3.13"/>
                    <measurement group_id="O2" value="3.94" spread="3.19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>RPQ-13</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.64" spread="7.83"/>
                    <measurement group_id="O2" value="10.94" spread="9.98"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>RPQ-Total</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.18" spread="10.01"/>
                    <measurement group_id="O2" value="14.88" spread="12.08"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse events were monitored/assessed during study enrollment through study completion, an average of 1 year.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Non-active LLLT Helmet Application</title>
          <description>A helmet containing near infrared LED's (LLLT helmet) will be applied to the head, however, the LEDs will not be turned on / activated.&#xD;
Non-active LLLT helmet application: LED helmet applied without light activated</description>
        </group>
        <group group_id="E2">
          <title>Active LLLT Helmet Application</title>
          <description>A helmet containing near infrared LEDs (LLLT helmet) will be applied and the LEDs will be turned on/activated&#xD;
Active LLLT helmet application: LED helmet applied with light activated</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="31"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Pancreatitis</sub_title>
                <description>Severe, unexpected, unrelated. Subject came back to hospital due to pancreatitis</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>MSSA bacteremia</sub_title>
                <description>Severe, unexpected, unrelated. Subject went back to hospital due to MSSA bacteremia</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Subdural hematoma</sub_title>
                <description>Severe, expected, unrelated. During data review a SDH was discovered on study MRI which was not present on clinical CT.</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Hospital visit due to headache</sub_title>
                <description>Severe, expected, unrelated.</description>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="31"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Suicidal Ideation</sub_title>
                <description>Severe, unexpected, unrelated. Subject went back to hospital due to suicidal ideation in the setting of intermittent depressive symptoms over years, chronic pain, and other difficulties. Evaluated and cleared by psychiatry.</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Hemorrhagic cystitis</sub_title>
                <description>Severe, unexpected, unrelated. Subject went back to hospital due to hemorrhagic cystitis.</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>COPD exacerbation</sub_title>
                <description>Severe, unexpected, unrelated. Subject went back to hospital due to COPD exacerbation.</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Operation for tibial &amp; fibular fracture</sub_title>
                <description>Severe, unexpected, unrelated. Subject came back for scheduled operation due to nonunion left distal tibial &amp; fibular fracture</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Rectal foreign body</sub_title>
                <description>Severe, unexpected, unrelated. Subject went back to hospital due to rectal foreign body</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="20" subjects_at_risk="31"/>
                <counts group_id="E2" subjects_affected="13" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Cataract surgery</sub_title>
                <description>Subject went back to hospital for cataract surgery</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Musculoskeletal neck pain</sub_title>
                <description>Subject went back to hospital due to neck pain.</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Symptom reporting</sub_title>
                <assessment>Systematic Assessment</assessment>
                <description>Reporting of one or more of the following: Headache, blurred vision, double vision, dizziness, numbness, NV, ringing, noise, light, forgetfulness, thinking, concentrating, irritable, frustrated, restless, sleeping, fatigue, depressed.</description>
                <counts group_id="E1" events="13" subjects_affected="13" subjects_at_risk="31"/>
                <counts group_id="E2" events="10" subjects_affected="10" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Numbness/tingling in toes</sub_title>
                <description>Subject reported numbness/tingling in toes 1 week to 3 month time point</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <description>Subject went back to hospital due to dizziness</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Hemorrhagic cyst</sub_title>
                <description>Hemorrhagic cyst</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Persistent cough</sub_title>
                <description>Subject visited urgent care for persistent cough</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Social circumstances</title>
            <event_list>
              <event>
                <sub_title>Alcohol abuse</sub_title>
                <description>Subject went back to hospital due to alcohol abuse/intoxication.</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E2" events="6" subjects_affected="1" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Fall</sub_title>
                <description>Subject went back to hospital due to fall</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Glass from motor vehicle accident removed</sub_title>
                <description>Subject went back to hospital to have glass from motor vehicle accident removed from skin on forehead.</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Broken nose</sub_title>
                <description>Subject went back to hospital to have broken nose corrected.</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Fracture repair</sub_title>
                <description>Subject went back to hospital for repair of zygomaticomaxillary complex (ZMC) and orbital floor fractures.</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Dislocated shoulder</sub_title>
                <description>Subject went back to hospital for dislocated shoulder</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Shoulder sprain</sub_title>
                <description>Subject returned to hospital due to motor vehicle accident with diagnosis of shoulder sprain</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Rajiv Gupta</name_or_title>
      <organization>Massachusetts General Hospital</organization>
      <phone>617-726-0369</phone>
      <email>rgupta1@mgh.harvard.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02233413
org study id: 2013P000430
secondary id: W81XWH-13-2-0067 CDMRP
nct id: NCT02233413
lead sponsor: 
has dmc: Yes
The purpose of this research study is to find out if a specialized helmet that provides low
      levels of near infrared light, also known as low-level light therapy (LLLT) has any effect on
      the recovery of people who have recently (within 72h) suffered a moderate traumatic brain
      injury (TBI).
The specific aim of this pilot study is to determine the feasibility of using the LLLT helmet
      in patients with moderate TBI and to quantify the response to LLLT using magnetic resonance
      (MR) and clinical outcome measures. We hypothesize that we will be able to quantify the
      response to LLLT through MR imaging and clinical outcome measures.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Safety and Feasibility of Applying Light Therapy After Moderate TBI
time frame: up to seven days after enrollment
description: Number of subjects to successfully complete light therapy without serious unanticipated adverse events related to application of the device.
measure: Neuroreactivity of Light Therapy to the Injured Brain Based on MRI Using the Fazekas Scale for Periventricular White Matter (PVWM)
time frame: up to 3 months after treatment
description: The presence of chronic white matter disease was evaluated using Fazekas scale. The scale divides the white matter in periventricular and deep white matter, and each region is given a grade depending on the size and confluence of lesions.
periventricular white matter (PVWM). 0 = absent
= "caps" or pencil-thin lining
= smooth "halo"
= irregular periventricular signal extending into the deep white matter
A neuroradiologist evaluated the 3D T2-SPACE-FLAIR images to detect the presence of T2 hyperintensities and their degree (0: absent; 1: mild; 2: moderate; and 3: severe) for PVWM. Higher values represent a worse outcome.
measure: Neuroreactivity of Light Therapy to the Injured Brain Based on MRI Using the Fazekas Scale for Deep White Matter (DWM)
time frame: up to 3 months after treatment
description: The presence of chronic white matter disease was evaluated using Fazekas scale. The scale divides the white matter in periventricular and deep white matter, and each region is given a grade depending on the size and confluence of lesions.
deep white matter (DWM) 0 = absent
= punctate foci
= beginning confluence
= large confluent areas
A neuroradiologist evaluated the 3D T2-SPACE-FLAIR images to detect the presence of T2 hyperintensities and their degree (0: absent; 1: mild; 2: moderate; and 3: severe) for DWM. Higher values represent a worse outcome.
measure: Neuroreactivity of Light Therapy to the Injured Brain Based on Neurcognitive Function
time frame: RPQ scores were collected at approx 72 hours, 14 days, 3 months, and 6 months and the mean was calculated for the values reported.
description: RPQ is a 16 item self-assessment questionnaire completed via an in-person or phone interview. Each item in the questionnaire is assessed on a 5-point scale ranging from 0 (no problem) - 4 (severe problem). The questions are grouped in two non-overlapping sets: the RPQ-3 includes early, objective, physical symptoms, and the RPQ-13 group includes later, more cognitive and behavioral symptoms. The RPQ-3 encompasses headache, dizziness, and nausea/vomiting. The RPQ-13 includes questions evaluating noise sensitivity, sleep disturbance, fatigue, irritability, depressed mood, forgetfulness, poor concentration, longer thinking time, blurred vision, light sensitivity, double vision, and restlessness. The RPQ-3 ranges from 0 - 12 (best to worst) and RPQ-13 ranges from 0 - 52 (best to worst). RPQ Total is the theoretical max/min RPQ score with a combined possible score ranging from 0-64 (best to worst). The outcome measures are
arm group label: Non-active LLLT helmet application
arm group type: Sham Comparator
description: A helmet containing near infrared LED's (LLLT helmet) will be applied to the head, however, the LEDs will not be turned on / activated.
arm group label: Active LLLT helmet application
arm group type: Active Comparator
description: A helmet containing near infrared LEDs (LLLT helmet) will be applied and the LEDs will be turned on/activated
intervention type: Device
intervention name: Active LLLT helmet application
description: LED helmet applied with light activated
arm group label: Active LLLT helmet application
intervention type: Device
intervention name: Non-active LLLT helmet application
description: LED helmet applied without light activated
arm group label: Non-active LLLT helmet application
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Rajiv Gupta, MD, PhD
role: Principal Investigator
affiliation: Massachusetts General Hospital
last name: Benjamin Vakoc, PhD
role: Study Director
affiliation: Massachussetts General Hospital
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Massachusetts General Hospital
investigator full name: Rajiv Gupta
investigator title: Principal Investigator
mesh term: Brain Injuries
mesh term: Brain Injuries, Traumatic
mesh term: Wounds and Injuries
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 