<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/NCT02993952</url>
  </required_header>
  <id_info>
    <org_study_id>1.839.742</org_study_id>
    <nct_id>NCT02993952</nct_id>
  </id_info>
  <brief_title>tDCS and Its Therapeutic Effects in CK Fever</brief_title>
  <official_title>Transcranial Direct Current Stimulation (tDCS) and Its Therapeutic Effects in Chikungunya Fever</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universidade Federal do Rio Grande do Norte</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universidade Federal do Rio Grande do Norte</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>
      One of the major challenges faced by researchers working in the field of rehabilitation&#xD;
      science is the ability to provide integrative approaches to the use of clinical practice. In&#xD;
      this context it becomes increasingly necessary to construct investigative approaches, so that&#xD;
      they can reach clinical practice in a shorter period of time,since the large volume of&#xD;
      information produced globally does not impact in the short or medium term on new therapeutic&#xD;
      recommendations. Among the various chronic painful entities, there is chikungunya fever as a&#xD;
      highlight for having a rich clinical chronology in relation to pain. Its therapy is used done&#xD;
      by drugs in almost all national and international consensuses, therefore therapy against pain&#xD;
      in chikungunya fever is limited during the rehabilitation process. It is very important that&#xD;
      the science of rehabilitation enhances methods of noninvasive brain modulation that enable,&#xD;
      through the excitation or inhibition of specific cortical areas to produce pain inhibiting&#xD;
      effects, providing a simple and low cost treatment to the clinical routine.Technological&#xD;
      advances and non-invasive techniques to modulate brain function have been developed, for&#xD;
      instance, Transcranial Direct Current Stimulation (tDCS).&#xD;
&#xD;
      The objective of the present project is to present the tDCS as a new modality of physical&#xD;
      rehabilitation for the patient with chronic pain resulting from chikungunya fever. The&#xD;
      purpose of the study is to present physical, behavioral and social results of the application&#xD;
      of tDCS in chikungunya fever, suggesting an improvement in the quality of life and functional&#xD;
      status of the individual.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 12, 2016</start_date>
  <completion_date type="Actual">March 10, 2017</completion_date>
  <primary_completion_date type="Actual">February 20, 2017</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>Change from baseline Pain at 3 weeks</measure>
    <time_frame>Every day during 3 weeks (before treatment, during treatment and one week after treatment).</time_frame>
    <description>Diary of pain</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline Pain at 3 weeks</measure>
    <time_frame>baseline (one week before starting stimulation), one week after baseline (after first stimulation), eleven days after baseline (after last stimulation) and 3 weeks after baseline.</time_frame>
    <description>Visual analogue scale.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline Pain at 3 weeks</measure>
    <time_frame>baseline (one week before starting stimulation), one week after baseline (after first stimulation), eleven days after baseline (after last stimulation) and 3 weeks after baseline.</time_frame>
    <description>Diagnosing Neuropathic Pain - DN4 Questionnaire</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline Pain at 3 weeks</measure>
    <time_frame>baseline (one week before starting stimulation), one week after baseline (after first stimulation), eleven days after baseline (after last stimulation) and 3 weeks after baseline.</time_frame>
    <description>McGill Pain Questionnaire short brazilian version (Br- MPQ)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline Pain at 3 weeks</measure>
    <time_frame>baseline (one week before starting stimulation), one week after baseline (after first stimulation), eleven days after baseline (after last stimulation) and 3 weeks after baseline.</time_frame>
    <description>Brief Pain Inventory (Short Form).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from baseline Quality of Life at 3 weeks</measure>
    <time_frame>baseline (one week before starting stimulation), one week after baseline (after first stimulation), eleven days after baseline (after last stimulation) and 3 weeks after baseline.</time_frame>
    <description>Short Form 36 Health Survey (SF-36).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline Flexibility at 3 weeks</measure>
    <time_frame>baseline (one week before starting stimulation), one week after baseline (after first stimulation), eleven days after baseline (after last stimulation) and 3 weeks after baseline.</time_frame>
    <description>Sit and Reach Flexibility Test.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline Flexibility at 3 weeks</measure>
    <time_frame>baseline (one week before starting stimulation), one week after baseline (after first stimulation), eleven days after baseline (after last stimulation) and 3 weeks after baseline.</time_frame>
    <description>Back Scratch Test.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline Strength at 3 weeks</measure>
    <time_frame>baseline (one week before starting stimulation), one week after baseline (after first stimulation), eleven days after baseline (after last stimulation) and 3 weeks after baseline.</time_frame>
    <description>The 30-Second Chair Stand Test.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline Strength at 3 weeks</measure>
    <time_frame>baseline (one week before starting stimulation), one week after baseline (after first stimulation), eleven days after baseline (after last stimulation) and 3 weeks after baseline.</time_frame>
    <description>Elbow flexion strength test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline Strength at 3 weeks</measure>
    <time_frame>baseline (one week before starting stimulation), one week after baseline (after first stimulation), eleven days after baseline (after last stimulation) and 3 weeks after baseline.</time_frame>
    <description>Manual Muscle Testing (Hand Dynamometer)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Chikungunya Fever</condition>
  <arm_group>
    <arm_group_label>Active stimulation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>A constant current (anodic) of 2mA will be applied for 20 minutes on the Primary motor cortex.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sham stimulation</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>A constant current (sham) of 2mA will be applied, but the stimulator will be turned off after 30 seconds on the Primary motor cortex.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Transcranial Direct Current Stimulation</intervention_name>
    <description>For electrode placement, the criteria used by the 10/20 electroencephalography system will be obeyed and the electrodes will be positioned area C3 for the anode and Fp2 (contralateral supraorbital area) for the cathode electrode. A constant current of 2mA will be applied for 20 minutes.</description>
    <arm_group_label>Active stimulation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Sham Transcranial Direct Current Stimulation</intervention_name>
    <description>For electrode placement, the criteria used by the 10/20 electroencephalography system will be obeyed and the electrodes will be positioned area C3 for the anode and Fp2 (contralateral supraorbital area) for the cathode electrode, but the stimulator was turned off after 30 seconds of stimulation. Therefore, patients in the sham group felt the initial itching sensation but received no current for the rest of the stimulation period.</description>
    <arm_group_label>Sham stimulation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Laboratory or medical diagnosis of chikungunya fever, being in the chronic phase of&#xD;
             the disease, intellectual and physical capacity preserved for conducting research&#xD;
             tests.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of seizures or epileptic disease, pregnancy, states associated with other&#xD;
             previously diagnosed rheumatic diseases such as rheumatoid arthritis, gout and lupus,&#xD;
             under 18 years and over 65 of age, patients with signs of severity and/or indication&#xD;
             for hospitalization.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Rodrigo Pegado Freitas, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Universidade Federal do Rio Grande do Norte</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Edson Meneses Filho, Graduate</last_name>
    <role>Principal Investigator</role>
    <affiliation>Universidade Federal do Rio Grande do Norte</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Federal University of Rio Grande do Norte</name>
      <address>
        <city>Santa cruz</city>
        <state>Rio Grande do Norte</state>
        <zip>59200-000</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>April 2017</verification_date>
  <study_first_submitted>December 5, 2016</study_first_submitted>
  <study_first_submitted_qc>December 14, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 15, 2016</study_first_posted>
  <last_update_submitted>April 17, 2017</last_update_submitted>
  <last_update_submitted_qc>April 17, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">April 18, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universidade Federal do Rio Grande do Norte</investigator_affiliation>
    <investigator_full_name>Edson meneses da silva filho</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Chikungunya Fever</mesh_term>
    <mesh_term>Fever</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/NCT02993952
org study id: 1.839.742
nct id: NCT02993952
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
One of the major challenges faced by researchers working in the field of rehabilitation
      science is the ability to provide integrative approaches to the use of clinical practice. In
      this context it becomes increasingly necessary to construct investigative approaches, so that
      they can reach clinical practice in a shorter period of time,since the large volume of
      information produced globally does not impact in the short or medium term on new therapeutic
      recommendations. Among the various chronic painful entities, there is chikungunya fever as a
      highlight for having a rich clinical chronology in relation to pain. Its therapy is used done
      by drugs in almost all national and international consensuses, therefore therapy against pain
      in chikungunya fever is limited during the rehabilitation process. It is very important that
      the science of rehabilitation enhances methods of noninvasive brain modulation that enable,
      through the excitation or inhibition of specific cortical areas to produce pain inhibiting
      effects, providing a simple and low cost treatment to the clinical routine.Technological
      advances and non-invasive techniques to modulate brain function have been developed, for
      instance, Transcranial Direct Current Stimulation (tDCS).

      The objective of the present project is to present the tDCS as a new modality of physical
      rehabilitation for the patient with chronic pain resulting from chikungunya fever. The
      purpose of the study is to present physical, behavioral and social results of the application
      of tDCS in chikungunya fever, suggesting an improvement in the quality of life and functional
      status of the individual.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Change from baseline Pain at 3 weeks
time frame: Every day during 3 weeks (before treatment, during treatment and one week after treatment).
description: Diary of pain
measure: Change from baseline Pain at 3 weeks
time frame: baseline (one week before starting stimulation), one week after baseline (after first stimulation), eleven days after baseline (after last stimulation) and 3 weeks after baseline.
description: Visual analogue scale.
measure: Change from baseline Pain at 3 weeks
time frame: baseline (one week before starting stimulation), one week after baseline (after first stimulation), eleven days after baseline (after last stimulation) and 3 weeks after baseline.
description: Diagnosing Neuropathic Pain - DN4 Questionnaire
measure: Change from baseline Pain at 3 weeks
time frame: baseline (one week before starting stimulation), one week after baseline (after first stimulation), eleven days after baseline (after last stimulation) and 3 weeks after baseline.
description: McGill Pain Questionnaire short brazilian version (Br- MPQ)
measure: Change from baseline Pain at 3 weeks
time frame: baseline (one week before starting stimulation), one week after baseline (after first stimulation), eleven days after baseline (after last stimulation) and 3 weeks after baseline.
description: Brief Pain Inventory (Short Form).
measure: Change from baseline Quality of Life at 3 weeks
time frame: baseline (one week before starting stimulation), one week after baseline (after first stimulation), eleven days after baseline (after last stimulation) and 3 weeks after baseline.
description: Short Form 36 Health Survey (SF-36).
measure: Change from baseline Flexibility at 3 weeks
time frame: baseline (one week before starting stimulation), one week after baseline (after first stimulation), eleven days after baseline (after last stimulation) and 3 weeks after baseline.
description: Sit and Reach Flexibility Test.
measure: Change from baseline Flexibility at 3 weeks
time frame: baseline (one week before starting stimulation), one week after baseline (after first stimulation), eleven days after baseline (after last stimulation) and 3 weeks after baseline.
description: Back Scratch Test.
measure: Change from baseline Strength at 3 weeks
time frame: baseline (one week before starting stimulation), one week after baseline (after first stimulation), eleven days after baseline (after last stimulation) and 3 weeks after baseline.
description: The 30-Second Chair Stand Test.
measure: Change from baseline Strength at 3 weeks
time frame: baseline (one week before starting stimulation), one week after baseline (after first stimulation), eleven days after baseline (after last stimulation) and 3 weeks after baseline.
description: Elbow flexion strength test
measure: Change from baseline Strength at 3 weeks
time frame: baseline (one week before starting stimulation), one week after baseline (after first stimulation), eleven days after baseline (after last stimulation) and 3 weeks after baseline.
description: Manual Muscle Testing (Hand Dynamometer)
arm group label: Active stimulation
arm group type: Active Comparator
description: A constant current (anodic) of 2mA will be applied for 20 minutes on the Primary motor cortex.
arm group label: Sham stimulation
arm group type: Sham Comparator
description: A constant current (sham) of 2mA will be applied, but the stimulator will be turned off after 30 seconds on the Primary motor cortex.
intervention type: Device
intervention name: Transcranial Direct Current Stimulation
description: For electrode placement, the criteria used by the 10/20 electroencephalography system will be obeyed and the electrodes will be positioned area C3 for the anode and Fp2 (contralateral supraorbital area) for the cathode electrode. A constant current of 2mA will be applied for 20 minutes.
arm group label: Active stimulation
intervention type: Device
intervention name: Sham Transcranial Direct Current Stimulation
description: For electrode placement, the criteria used by the 10/20 electroencephalography system will be obeyed and the electrodes will be positioned area C3 for the anode and Fp2 (contralateral supraorbital area) for the cathode electrode, but the stimulator was turned off after 30 seconds of stimulation. Therefore, patients in the sham group felt the initial itching sensation but received no current for the rest of the stimulation period.
arm group label: Sham stimulation
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Rodrigo Pegado Freitas, PhD
role: Study Director
affiliation: Universidade Federal do Rio Grande do Norte
last name: Edson Meneses Filho, Graduate
role: Principal Investigator
affiliation: Universidade Federal do Rio Grande do Norte
facility: 
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: Universidade Federal do Rio Grande do Norte
investigator full name: Edson meneses da silva filho
investigator title: Principal Investigator
mesh term: Chikungunya Fever
mesh term: Fever
sharing ipd: No