<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/NCT03759132</url>
  </required_header>
  <id_info>
    <org_study_id>tDCS in Parkinson's Disease</org_study_id>
    <nct_id>NCT03759132</nct_id>
  </id_info>
  <brief_title>Effects of Transcranial Direct Current Stimulation on Postural Control</brief_title>
  <official_title>Effects of Transcranial Direct Current Stimulation on Postural Control: a Double-blind Randomized Controlled Trial.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universidade Federal do Piauí</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universidade Federal do Piauí</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Parkinson's disease is a progressive, degenerative neurological disease associated with&#xD;
      profound changes in the quality of life of its survivors. Recent evidence has demonstrated&#xD;
      the potential use of transcranial direct current stimulation (tDCS) to modulate cerebral&#xD;
      excitability and movement control in neurological chronic conditions. However, few studies&#xD;
      have investigated the effects of tDCS on postural control in patients with Parkinson's&#xD;
      disease. This study aims to investigate the effect of bihemispheric tDCS on postural control&#xD;
      in people with Parkinson's disease. Participants will be randomized to receive a single&#xD;
      session of anodal and sham bihemispheric tDCS (7 days between each type of stimulation).&#xD;
&#xD;
      Primary clinical outcome (balance) will be collected before and immediately after tDCS. The&#xD;
      data will be collected by a blind examiner to the treatment allocation.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 1, 2018</start_date>
  <completion_date type="Actual">October 30, 2020</completion_date>
  <primary_completion_date type="Actual">June 30, 2020</primary_completion_date>
  <phase>Phase 2/Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from COP - AP axis</measure>
    <time_frame>Baseline and Post-tDCS (immediately after tDCS)</time_frame>
    <description>Postural instability will be evaluated using a force plate to record center of pressure displacement (COP) in antero-posterior (AP) axis in centimeters.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from COP - ML axis</measure>
    <time_frame>Baseline and Post-tDCS (immediately after tDCS)</time_frame>
    <description>Postural instability will be evaluated using a force plate to record center of pressure displacement (COP) in Mediolateral (ML) axis in centimeters.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from COP - area</measure>
    <time_frame>Baseline and Post-tDCS (immediately after tDCS)</time_frame>
    <description>Postural instability will be evaluated using a force plate to record center of pressure displacement (COP) area (cm²).</description>
  </primary_outcome>
  <other_outcome>
    <measure>Adverse effects</measure>
    <time_frame>Immediately after tDCS</time_frame>
    <description>Adverse effects will be evaluated using structured questionnaire</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">18</enrollment>
  <condition>Parkinson Disease</condition>
  <arm_group>
    <arm_group_label>Anodal tDCS</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Bihemispheric tDCS applied over primary motor cortex.&#xD;
Dose: 2mA, 20 minutes</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sham tDCS</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Bihemispheric tDCS applied over primary motor cortex.&#xD;
Dose: 2mA, 20 minutes (30s ON)</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Transcranial direct current stimulation</intervention_name>
    <description>Transcranial direct current stimulation is a noninvasive technique of neuronal modulation that has been used in different chronic neurological conditions, including Parkinson's disease.</description>
    <arm_group_label>Anodal tDCS</arm_group_label>
    <arm_group_label>Sham tDCS</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Medical diagnosis of idiopathic Parkinson's disease present for at least 12 months&#xD;
&#xD;
        In clinical follow-up and pharmacological treatment by a responsible physician&#xD;
&#xD;
        Parkinson's classification of 1.5-3 according to the Hoehn and Yahr scale&#xD;
&#xD;
        Signing of the free and informed consent form-&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Use any associated orthopedic device to aid gait or balance control&#xD;
&#xD;
        Signs of severe dementia (evaluated by the Mini-Mental State Examination - MMSE)&#xD;
&#xD;
        Diagnosis of other neurological disorders (including those of central and peripheral&#xD;
        nature)&#xD;
&#xD;
        Previous treatment with tDCS&#xD;
&#xD;
        Medical diagnosis of psychiatric illnesses with the use of centrally acting medications&#xD;
        (depressants)&#xD;
&#xD;
        The use of pacemakers or other implanted devices.-&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Department of Physical Therapy. Federal University of Piaui</name>
      <address>
        <city>Parnaíba</city>
        <state>Piauí</state>
        <zip>64202020</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>November 21, 2018</study_first_submitted>
  <study_first_submitted_qc>November 28, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 29, 2018</study_first_posted>
  <last_update_submitted>November 2, 2020</last_update_submitted>
  <last_update_submitted_qc>November 2, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 4, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universidade Federal do Piauí</investigator_affiliation>
    <investigator_full_name>Fuad Ahmad Hazime</investigator_full_name>
    <investigator_title>Assistant Professor - Physical Therapy Department</investigator_title>
  </responsible_party>
  <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/NCT03759132
org study id: tDCS in Parkinson's Disease
nct id: NCT03759132
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Parkinson's disease is a progressive, degenerative neurological disease associated with
      profound changes in the quality of life of its survivors. Recent evidence has demonstrated
      the potential use of transcranial direct current stimulation (tDCS) to modulate cerebral
      excitability and movement control in neurological chronic conditions. However, few studies
      have investigated the effects of tDCS on postural control in patients with Parkinson's
      disease. This study aims to investigate the effect of bihemispheric tDCS on postural control
      in people with Parkinson's disease. Participants will be randomized to receive a single
      session of anodal and sham bihemispheric tDCS (7 days between each type of stimulation).

      Primary clinical outcome (balance) will be collected before and immediately after tDCS. The
      data will be collected by a blind examiner to the treatment allocation.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Change from COP - AP axis
time frame: Baseline and Post-tDCS (immediately after tDCS)
description: Postural instability will be evaluated using a force plate to record center of pressure displacement (COP) in antero-posterior (AP) axis in centimeters.
measure: Change from COP - ML axis
time frame: Baseline and Post-tDCS (immediately after tDCS)
description: Postural instability will be evaluated using a force plate to record center of pressure displacement (COP) in Mediolateral (ML) axis in centimeters.
measure: Change from COP - area
time frame: Baseline and Post-tDCS (immediately after tDCS)
description: Postural instability will be evaluated using a force plate to record center of pressure displacement (COP) area (cm²).
measure: Adverse effects
time frame: Immediately after tDCS
description: Adverse effects will be evaluated using structured questionnaire
arm group label: Anodal tDCS
arm group type: Experimental
description: Bihemispheric tDCS applied over primary motor cortex.
Dose: 2mA, 20 minutes
arm group label: Sham tDCS
arm group type: Sham Comparator
description: Bihemispheric tDCS applied over primary motor cortex.
Dose: 2mA, 20 minutes (30s ON)
intervention type: Procedure
intervention name: Transcranial direct current stimulation
description: Transcranial direct current stimulation is a noninvasive technique of neuronal modulation that has been used in different chronic neurological conditions, including Parkinson's disease.
arm group label: Anodal tDCS
arm group label: Sham tDCS
criteria: 
gender: All
minimum age: 40 Years
maximum age: 70 Years
healthy volunteers: No
facility: 
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: Universidade Federal do Piauí
investigator full name: Fuad Ahmad Hazime
investigator title: Assistant Professor - Physical Therapy Department
mesh term: Parkinson Disease
sharing ipd: No