<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/NCT03281759</url>
  </required_header>
  <id_info>
    <org_study_id>15425</org_study_id>
    <nct_id>NCT03281759</nct_id>
  </id_info>
  <brief_title>Transcranial LED Therapy for Severe Acute Traumatic Brain Injury</brief_title>
  <acronym>LED-TBI</acronym>
  <official_title>Effects of Transcranial LED Therapy on the Cognitive Rehabilitation for Diffuse Axonal Injury Due to Severe Acute Traumatic Brain Injury: Randomized Clinical Trial.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Sao Paulo General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Sao Paulo General Hospital</source>
  <oversight_info>
    <has_dmc>Yes</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 purpose of this study is to evaluate early and delayed effects of Transcranial LED&#xD;
      Therapy (TCLT) and determinate whether this therapy is effective for cognitive rehabilitation&#xD;
      of Diffuse Axonal Injury patients after Traumatic Brain Injury.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a randomized clinical trial of patient with diffuse axonal injury (DAI) secondary to&#xD;
      severe Traumatic Brain Injury in its acute stage (less than 8h). It will be recruited thirty&#xD;
      adult patients who will receive thirty minutes at three times per week for 6 weeks (18&#xD;
      sessions) of transcranial stimulation. Fifteen of them will be stimulated with LED helmet and&#xD;
      the rest with a sham helmet identical to the LED one, but only with a similar red light&#xD;
      emission. Patient who meet inclusion criteria will be assessed with Glasgow Outcome Scale&#xD;
      Extended (GOS-E) evaluation in at least five different periods (Admission, before and after&#xD;
      each stimulation, and at 3 and 6 months later in outpatient followup).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Anticipated">October 1, 2017</start_date>
  <completion_date type="Anticipated">December 1, 2018</completion_date>
  <primary_completion_date type="Anticipated">October 1, 2018</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>
  </study_design_info>
  <primary_outcome>
    <measure>Improvement of early and delayed functional outcome measured by Glasgow Outcome Scale Extended (GOSE).</measure>
    <time_frame>Before stimulation and 1, 3 and 6 months after first stimulation</time_frame>
    <description>Evaluation of improvement of early and delayed functional outcome measured by Glasgow Outcome Scale Extended (GOSE) after stimulation in comparison to the placebo group.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Improvement effects of transcranial LED in followup images measured by Marshall computed tomography scale and Adams grading scale for diffuse axonal injury.</measure>
    <time_frame>Before stimulation and 1, 3 and 6 months after first stimulation</time_frame>
    <description>Evaluation of early and delayed effects of Transcranial LED Therapy (TCLT) to improve followup computed tomography or magnetic resonance of DAI patients after Traumatic Brain Injury, measured by Marshal computed tomography scale, Adams grading scale for diffuse axonal injury and a protocol published by Hamdeh et al. (doi: 10.1089/neu.2016.4426) which graduates the magnitude of diffuse axonal lesion.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hemodynamic improvement effect of transcranial LED measured by transcranial doppler (systolic and diastolic velocity of the left middle cerebral and basilar arteries, and the pulsatility index and resistance index values).</measure>
    <time_frame>Before stimulation and 1, 3 and 6 months after first stimulation</time_frame>
    <description>Improvement evaluation of effects of LED therapy in hemodynamic change through transcranial doppler, measuring systolic and diastolic velocity of the left middle cerebral and basilar arteries, and the pulsatility index and resistance index values.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Diffuse Axonal Brain Injury</condition>
  <condition>Traumatic Brain Injury</condition>
  <arm_group>
    <arm_group_label>Active Coil Helmet</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The patients will undergo 18 sessions (627 nm, 70 mW/cm2, 10 J/cm2) at four points of the frontal and parietal region for 30 s each, totaling 120 s three times per week for 6 weeks, lasting 30 minutes of transcranial LED stimulation.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Inactive Coil Helmet</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>The patients assigned to this group will undergo 18 sessions of transcranial LED but with an inactive coil, which will not generate LED emissions.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Transcranial LED Therapy (Active coil helmet)</intervention_name>
    <description>The patients will undergo 18 sessions of repetitive transcranial LED stimulation.</description>
    <arm_group_label>Active Coil Helmet</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Transcranial LED Therapy (Inactive coil helmet)</intervention_name>
    <description>The patients assigned to this group will undergo 18 sessions of transcranial LED but with an inactive coil, which will not generate LED emissions, only a similar red light color.</description>
    <arm_group_label>Inactive Coil Helmet</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        1) Patient victims of Traumatic Brain Injury with Glasgow Coma Scale ≤8 on admission:&#xD;
&#xD;
          1. Head CT scan showing diffuse axonal lesion.&#xD;
&#xD;
          2. CT scan without focal surgical lesions (Marshall I and II) and no signs of&#xD;
             intracranial hypertension.&#xD;
&#xD;
          3. Transcranial Doppler and optic nerve sheath US with no signs of intracranial&#xD;
             hypertension.&#xD;
&#xD;
          4. Admission less than 8 hours of trauma.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. History of drug or narcotic abuse.&#xD;
&#xD;
          2. Emergence of surgical lesions or signs of intracranial hypertension in followup CTs.&#xD;
&#xD;
          3. Transcranial Doppler or optic nerve sheath US presenting signs of intracranial&#xD;
             hypertension.&#xD;
&#xD;
          4. Psychiatric disorders.&#xD;
&#xD;
          5. Injury severity score ≥3, according to the Abbreviated Injury Scale&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Wellingson S Paiva, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>University of Sao Paulo General Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Joao G Santos, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Sao Paulo General Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Joao G Santos, MD</last_name>
    <phone>+5511941989876</phone>
    <email>joao.gustavo.rps@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Wellingson S Paiva, PHD</last_name>
    <phone>+5511975992245</phone>
  </overall_contact_backup>
  <location>
    <facility>
      <name>University of Sao Paulo General Hospital</name>
      <address>
        <city>São Paulo</city>
        <state>SP</state>
        <zip>05401-000</zip>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Joao G Santos, MD</last_name>
      <phone>+5511941989876</phone>
      <email>joao.gustavo.rps@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>September 4, 2017</study_first_submitted>
  <study_first_submitted_qc>September 11, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 13, 2017</study_first_posted>
  <last_update_submitted>September 11, 2017</last_update_submitted>
  <last_update_submitted_qc>September 11, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 13, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Brain Injuries, Traumatic;</keyword>
  <keyword>Diffuse Axonal Injury</keyword>
  <keyword>Low-Level Light Therapy</keyword>
  <keyword>Neurologic Manifestations</keyword>
  <keyword>Quality of Life</keyword>
  <keyword>Rehabilitation</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>Diffuse Axonal Injury</mesh_term>
    <mesh_term>Brain Injuries, Diffuse</mesh_term>
    <mesh_term>Wounds and Injuries</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03281759
org study id: 15425
nct id: NCT03281759
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to evaluate early and delayed effects of Transcranial LED
      Therapy (TCLT) and determinate whether this therapy is effective for cognitive rehabilitation
      of Diffuse Axonal Injury patients after Traumatic Brain Injury.
This is a randomized clinical trial of patient with diffuse axonal injury (DAI) secondary to
      severe Traumatic Brain Injury in its acute stage (less than 8h). It will be recruited thirty
      adult patients who will receive thirty minutes at three times per week for 6 weeks (18
      sessions) of transcranial stimulation. Fifteen of them will be stimulated with LED helmet and
      the rest with a sham helmet identical to the LED one, but only with a similar red light
      emission. Patient who meet inclusion criteria will be assessed with Glasgow Outcome Scale
      Extended (GOS-E) evaluation in at least five different periods (Admission, before and after
      each stimulation, and at 3 and 6 months later in outpatient followup).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Improvement of early and delayed functional outcome measured by Glasgow Outcome Scale Extended (GOSE).
time frame: Before stimulation and 1, 3 and 6 months after first stimulation
description: Evaluation of improvement of early and delayed functional outcome measured by Glasgow Outcome Scale Extended (GOSE) after stimulation in comparison to the placebo group.
measure: Improvement effects of transcranial LED in followup images measured by Marshall computed tomography scale and Adams grading scale for diffuse axonal injury.
time frame: Before stimulation and 1, 3 and 6 months after first stimulation
description: Evaluation of early and delayed effects of Transcranial LED Therapy (TCLT) to improve followup computed tomography or magnetic resonance of DAI patients after Traumatic Brain Injury, measured by Marshal computed tomography scale, Adams grading scale for diffuse axonal injury and a protocol published by Hamdeh et al. (doi: 10.1089/neu.2016.4426) which graduates the magnitude of diffuse axonal lesion.
measure: Hemodynamic improvement effect of transcranial LED measured by transcranial doppler (systolic and diastolic velocity of the left middle cerebral and basilar arteries, and the pulsatility index and resistance index values).
time frame: Before stimulation and 1, 3 and 6 months after first stimulation
description: Improvement evaluation of effects of LED therapy in hemodynamic change through transcranial doppler, measuring systolic and diastolic velocity of the left middle cerebral and basilar arteries, and the pulsatility index and resistance index values.
arm group label: Active Coil Helmet
arm group type: Active Comparator
description: The patients will undergo 18 sessions (627 nm, 70 mW/cm2, 10 J/cm2) at four points of the frontal and parietal region for 30 s each, totaling 120 s three times per week for 6 weeks, lasting 30 minutes of transcranial LED stimulation.
arm group label: Inactive Coil Helmet
arm group type: Placebo Comparator
description: The patients assigned to this group will undergo 18 sessions of transcranial LED but with an inactive coil, which will not generate LED emissions.
intervention type: Device
intervention name: Transcranial LED Therapy (Active coil helmet)
description: The patients will undergo 18 sessions of repetitive transcranial LED stimulation.
arm group label: Active Coil Helmet
intervention type: Device
intervention name: Transcranial LED Therapy (Inactive coil helmet)
description: The patients assigned to this group will undergo 18 sessions of transcranial LED but with an inactive coil, which will not generate LED emissions, only a similar red light color.
arm group label: Inactive Coil Helmet
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: Wellingson S Paiva, PhD
role: Study Chair
affiliation: University of Sao Paulo General Hospital
last name: Joao G Santos, MD
role: Principal Investigator
affiliation: University of Sao Paulo General Hospital
last name: Joao G Santos, MD
phone: +5511941989876
email: joao.gustavo.rps@gmail.com
last name: Wellingson S Paiva, PHD
phone: +5511975992245
facility: 
status: Recruiting
contact: 
country: Brazil
responsible party type: Sponsor
mesh term: Brain Injuries
mesh term: Brain Injuries, Traumatic
mesh term: Diffuse Axonal Injury
mesh term: Brain Injuries, Diffuse
mesh term: Wounds and Injuries
sharing ipd: Undecided