<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/NCT03811613</url>
  </required_header>
  <id_info>
    <org_study_id>#08/18</org_study_id>
    <nct_id>NCT03811613</nct_id>
  </id_info>
  <brief_title>Photobiomodulation and Parkinson</brief_title>
  <official_title>Photobiomodulation in Parkinson´s Disease: A Randomized Controlled Trial.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Oviedo</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Oviedo</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 aimed to assess the effects of transcranial photobiomodulation in patients with&#xD;
      Parkinson's disease (PD).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Thirty-five patients with idiopathic PD were randomly assigned to a photobiomodulation (n=17,&#xD;
      [mean±SD] 72±7 years) or sham group (n=18, 70±8 years) during 9 weeks (2 sessions/week). The&#xD;
      primary endpoint was the motor portion of the Movement Disorders Society-United PD Rating&#xD;
      Scale. Secondary endpoints were the Scales for Outcomes in PD, static posturography, walking&#xD;
      ability (ten-meter walk test [TMWT]) and functional mobility (timed up and go [TUG] test).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 29, 2018</start_date>
  <completion_date type="Actual">March 30, 2018</completion_date>
  <primary_completion_date type="Actual">March 30, 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>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The motor portion of the MDS-UPDRS.</measure>
    <time_frame>9 weeks</time_frame>
    <description>The motor portion (part III) Movement Disorders Society-Unified PD Rating Scale. It assesses the motor signs of Parkinson´s disease (minimum and maximum score is 0 and 76 points respectively -the higher score, the higher movement disorder and vice versa-).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Motor function</measure>
    <time_frame>9 weeks</time_frame>
    <description>The Spanish-validated version of the Short Parkinson's Evaluation Scale (SPES)/Scales for Outcomes in PD (SCOPA). It measures the Parkinson´s disease patients motor function (minimum and maximum score is 0 and 63 points respectively -the higher score, the worse motor function and vice versa-).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Static posturography</measure>
    <time_frame>9 weeks</time_frame>
    <description>The centre of pressure (CoP) parameters (these CoP parameters; Length in mm, Area in mm2 and Speed in m/s are combined to report the static posturography).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Walking speed</measure>
    <time_frame>9 weeks</time_frame>
    <description>Ten-meter walk test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>TUG</measure>
    <time_frame>9 weeks</time_frame>
    <description>Timed up and go test</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">35</enrollment>
  <condition>Parkinson Disease</condition>
  <arm_group>
    <arm_group_label>Photobiomodulation group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>17 Parkinson´s disease patients were randomly assigned to the photobiomodulation group (experimental group).&#xD;
Intervention: Photobiomodulation was administered using red light-emitting diodes (LEDs) with a 670-nm wavelength in six 1-minute blocks alternating the LEDs between the right and left temples, with a 30-second rest between blocks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sham group</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>18 Parkinson´s disease patients were randomly assigned to the sham group.&#xD;
Intervention: Procedures for the sham group were identical as the photobiomodulation one, except that patients received photobiomodulation during only 5 seconds followed by 55 seconds with no treatment (equalling 1/12th of the energy used for the intervention group).</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Transcranial photobiomodulation</intervention_name>
    <description>Photobiomodulation was administered using red light-emitting diodes (LEDs) with a 670-nm wavelength (which has proven to penetrate the skull)</description>
    <arm_group_label>Photobiomodulation group</arm_group_label>
    <arm_group_label>Sham group</arm_group_label>
    <other_name>LEDs</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Having been diagnosed with idiopathic PD.&#xD;
&#xD;
          -  Stage 1-2 on the Hoehn and Yahr Scale.&#xD;
&#xD;
          -  Having no neurological condition other than PD.&#xD;
&#xD;
          -  Being able to stand for 2 minutes and walk 10 meters without assistance.&#xD;
&#xD;
          -  Having no severe dyskinesias or &quot;ON-OFF&quot; phases.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        - Do not follow inclusion criteria.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Luis Santos, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Physical Education and Sport (University of León, Spain)</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University School of Sports Medicine, University of Oviedo, Spain.</name>
      <address>
        <city>Oviedo</city>
        <state>Asturias</state>
        <zip>33005</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Department of Physical Education and Sport, University of León</name>
      <address>
        <city>León</city>
        <state>Castilla Y León</state>
        <zip>24071</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 15, 2019</study_first_submitted>
  <study_first_submitted_qc>January 18, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 22, 2019</study_first_posted>
  <last_update_submitted>January 18, 2019</last_update_submitted>
  <last_update_submitted_qc>January 18, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 22, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universidad de León</investigator_affiliation>
    <investigator_full_name>Luis Santos</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>movement disorders</keyword>
  <keyword>light therapy</keyword>
  <keyword>motor aspects</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Parkinson Disease</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/NCT03811613
org study id: #08/18
nct id: NCT03811613
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study aimed to assess the effects of transcranial photobiomodulation in patients with
      Parkinson's disease (PD).
Thirty-five patients with idiopathic PD were randomly assigned to a photobiomodulation (n=17,
      [mean±SD] 72±7 years) or sham group (n=18, 70±8 years) during 9 weeks (2 sessions/week). The
      primary endpoint was the motor portion of the Movement Disorders Society-United PD Rating
      Scale. Secondary endpoints were the Scales for Outcomes in PD, static posturography, walking
      ability (ten-meter walk test [TMWT]) and functional mobility (timed up and go [TUG] test).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: The motor portion of the MDS-UPDRS.
time frame: 9 weeks
description: The motor portion (part III) Movement Disorders Society-Unified PD Rating Scale. It assesses the motor signs of Parkinson´s disease (minimum and maximum score is 0 and 76 points respectively -the higher score, the higher movement disorder and vice versa-).
measure: Motor function
time frame: 9 weeks
description: The Spanish-validated version of the Short Parkinson's Evaluation Scale (SPES)/Scales for Outcomes in PD (SCOPA). It measures the Parkinson´s disease patients motor function (minimum and maximum score is 0 and 63 points respectively -the higher score, the worse motor function and vice versa-).
measure: Static posturography
time frame: 9 weeks
description: The centre of pressure (CoP) parameters (these CoP parameters; Length in mm, Area in mm2 and Speed in m/s are combined to report the static posturography).
measure: Walking speed
time frame: 9 weeks
description: Ten-meter walk test
measure: TUG
time frame: 9 weeks
description: Timed up and go test
arm group label: Photobiomodulation group
arm group type: Experimental
description: 17 Parkinson´s disease patients were randomly assigned to the photobiomodulation group (experimental group).
Intervention: Photobiomodulation was administered using red light-emitting diodes (LEDs) with a 670-nm wavelength in six 1-minute blocks alternating the LEDs between the right and left temples, with a 30-second rest between blocks.
arm group label: Sham group
arm group type: Sham Comparator
description: 18 Parkinson´s disease patients were randomly assigned to the sham group.
Intervention: Procedures for the sham group were identical as the photobiomodulation one, except that patients received photobiomodulation during only 5 seconds followed by 55 seconds with no treatment (equalling 1/12th of the energy used for the intervention group).
intervention type: Other
intervention name: Transcranial photobiomodulation
description: Photobiomodulation was administered using red light-emitting diodes (LEDs) with a 670-nm wavelength (which has proven to penetrate the skull)
arm group label: Photobiomodulation group
arm group label: Sham group
other name: LEDs
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Luis Santos, PhD
role: Principal Investigator
affiliation: Department of Physical Education and Sport (University of León, Spain)
facility: 
facility: 
country: Spain
responsible party type: Principal Investigator
investigator affiliation: Universidad de León
investigator full name: Luis Santos
investigator title: Principal Investigator
mesh term: Parkinson Disease
sharing ipd: No