<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/NCT03008720</url>
  </required_header>
  <id_info>
    <org_study_id>767.866</org_study_id>
    <nct_id>NCT03008720</nct_id>
  </id_info>
  <brief_title>Evaluation of Electrical Activity Tibial Muscle and Postural Control of Individuals With Hemiparesia Post TDCS Associated With FES</brief_title>
  <official_title>EVALUATION OF ELECTRICAL ACTIVITY TIBIAL MUSCLE AND POSTURAL CONTROL OF INDIVIDUALS WITH HEMIPARESIA FROM AVE SUBMITTED TDCS ASSOCIATED WITH FES - CLINICAL STUDY, RANDOMIZED, DOUBLE BLIND.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Nove de Julho</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Nove de Julho</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Introduction: It is suggested that increased cortical activity, induced by cerebral&#xD;
      stimulation associated or not with other rehabilitation techniques, may potentiate the motor&#xD;
      and functional therapeutic effects in individuals with neurological deficits. Objectives: To&#xD;
      evaluate the electrical activity of the anterior tibial muscle (TA) and postural control of&#xD;
      individuals with hemiparesis due to stroke following treatment with transcranial direct&#xD;
      current (tDCS) stimulation and functional electrical stimulation (FES), associated or&#xD;
      isolated). (EMG) and postural control by the Balance Evaluation Systems Test (BESTest). Both&#xD;
      of which were collected at four different time points: pre-treatment, immediately after 10&#xD;
      treatment sessions, and 30 days follow-up after the interventions. Patients will be&#xD;
      randomized into 4 experimental groups: tDCS anodic active + active FES+ active contraction&#xD;
      TA, tDCS sham + active FES+ active contraction TA, tDCS anodic active+ placebo FES+ active&#xD;
      contraction TA, tDCS sham+ FES sham+ active contraction TA. tDCS (2mA) will be applied over&#xD;
      the motor (Cz) and cathodic vertex over the supraorbital region of the normal hemisphere and&#xD;
      FES over hemiparetic TA by a researcher who will not be the one who will evaluate the&#xD;
      anesthesia patient. The treatment will last 10 sessions, twice a week, with a time of 20&#xD;
      minutes.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>February 2017</start_date>
  <completion_date type="Anticipated">November 2018</completion_date>
  <primary_completion_date type="Anticipated">November 2017</primary_completion_date>
  <phase>Phase 2</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>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>electrical activity (median frequency and amplitude of the electromyographic signal) of the anterior tibial muscle</measure>
    <time_frame>1 YEAR</time_frame>
  </primary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">2</enrollment>
  <condition>Hemiparesis</condition>
  <condition>Transcranial Direct Current Stimulation</condition>
  <condition>Electromyography</condition>
  <arm_group>
    <arm_group_label>tDCS active</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Transcranial stimulation ( tDCS ) active will be administered using Tct Research 1 CH tdcs Simulator model 101. tDCS will be performed for 20 minutes and intensity 2mA associated active contraction of the TA muscle.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>tDCS sham</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo tDCS will follow the same procedures as active tDCS with active, but the tDCS device will only be switched on for 20 seconds.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>FES active</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Functional electrical stimulation (FES) active will be administered using QUARK® FES VIF 995 DUAL device. The duration of active FES will be 20 minutes, associated with active contraction of the TA muscle. The pulse width will be 250 μs, modulated at a frequency of 50 Hz, with one to two stimulation cycles (6 seconds on and 12 seconds off) and the intensity will be increased until reaching the motor threshold.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>FES sham</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo FES will follow the same procedures as active FES , but the FES device will only be switched on for 20 seconds, following which the intensity will be gradually reduced to 0 mA.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Transcranial direct current stimulation (tDCS)</intervention_name>
    <arm_group_label>tDCS active</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Functional electrical stimulation (FES)</intervention_name>
    <arm_group_label>FES active</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Sham stimulation</intervention_name>
    <arm_group_label>FES sham</arm_group_label>
    <arm_group_label>tDCS sham</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          -  Individuals with hemiparesis due to stroke;&#xD;
&#xD;
          -  Both sexes;&#xD;
&#xD;
          -  Agree to sign the free and informed consent form.&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  Positive cut-off point for the Mini Mental State Examination (MMSE) of less than 11&#xD;
             points already corrected for schooling;&#xD;
&#xD;
          -  Ankle mobility reduced by history of fracture or use of ankle fasteners;&#xD;
&#xD;
          -  Irreducible equine deformity;&#xD;
&#xD;
          -  Muscle strength level of AT less than 1 by the scale of Kendall;&#xD;
&#xD;
          -  Patients with reported severe visual impairment;&#xD;
&#xD;
          -  Contraindications to the use of transcranial direct current stimulation (history of&#xD;
             seizure or recurrent epilepsy, brain tumors at the stimulation site, metallic&#xD;
             materials implanted in the brain);&#xD;
&#xD;
          -  Individuals with cutaneous infection at the point of application of FECC or FES;&#xD;
&#xD;
          -  Individuals who presented anesthesia or hyperesthesia at the point of application of&#xD;
             the ECTS;&#xD;
&#xD;
          -  Individuals diagnosed with deep venous thrombosis (DVT);&#xD;
&#xD;
          -  Individuals diagnosed with degenerative diseases or polyneuropathies.&#xD;
&#xD;
          -  Individuals who do not present complementary tests that diagnose the lesion site.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Months</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>December 28, 2016</study_first_submitted>
  <study_first_submitted_qc>December 30, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 2, 2017</study_first_posted>
  <last_update_submitted>January 1, 2017</last_update_submitted>
  <last_update_submitted_qc>January 1, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 4, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Nove de Julho</investigator_affiliation>
    <investigator_full_name>Aline Marina Alves Fruhauf</investigator_full_name>
    <investigator_title>Professor of graduation.</investigator_title>
  </responsible_party>
  <keyword>functional electrical simulation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Paresis</mesh_term>
  </condition_browse>
  <!-- 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/NCT03008720
org study id: 767.866
nct id: NCT03008720
lead sponsor: 
has dmc: No
Introduction: It is suggested that increased cortical activity, induced by cerebral
      stimulation associated or not with other rehabilitation techniques, may potentiate the motor
      and functional therapeutic effects in individuals with neurological deficits. Objectives: To
      evaluate the electrical activity of the anterior tibial muscle (TA) and postural control of
      individuals with hemiparesis due to stroke following treatment with transcranial direct
      current (tDCS) stimulation and functional electrical stimulation (FES), associated or
      isolated). (EMG) and postural control by the Balance Evaluation Systems Test (BESTest). Both
      of which were collected at four different time points: pre-treatment, immediately after 10
      treatment sessions, and 30 days follow-up after the interventions. Patients will be
      randomized into 4 experimental groups: tDCS anodic active + active FES+ active contraction
      TA, tDCS sham + active FES+ active contraction TA, tDCS anodic active+ placebo FES+ active
      contraction TA, tDCS sham+ FES sham+ active contraction TA. tDCS (2mA) will be applied over
      the motor (Cz) and cathodic vertex over the supraorbital region of the normal hemisphere and
      FES over hemiparetic TA by a researcher who will not be the one who will evaluate the
      anesthesia patient. The treatment will last 10 sessions, twice a week, with a time of 20
      minutes.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: electrical activity (median frequency and amplitude of the electromyographic signal) of the anterior tibial muscle
time frame: 1 YEAR
arm group label: tDCS active
arm group type: Active Comparator
description: Transcranial stimulation ( tDCS ) active will be administered using Tct Research 1 CH tdcs Simulator model 101. tDCS will be performed for 20 minutes and intensity 2mA associated active contraction of the TA muscle.
arm group label: tDCS sham
arm group type: Placebo Comparator
description: Placebo tDCS will follow the same procedures as active tDCS with active, but the tDCS device will only be switched on for 20 seconds.
arm group label: FES active
arm group type: Active Comparator
description: Functional electrical stimulation (FES) active will be administered using QUARK® FES VIF 995 DUAL device. The duration of active FES will be 20 minutes, associated with active contraction of the TA muscle. The pulse width will be 250 μs, modulated at a frequency of 50 Hz, with one to two stimulation cycles (6 seconds on and 12 seconds off) and the intensity will be increased until reaching the motor threshold.
arm group label: FES sham
arm group type: Placebo Comparator
description: Placebo FES will follow the same procedures as active FES , but the FES device will only be switched on for 20 seconds, following which the intensity will be gradually reduced to 0 mA.
intervention type: Device
intervention name: Transcranial direct current stimulation (tDCS)
arm group label: tDCS active
intervention type: Device
intervention name: Functional electrical stimulation (FES)
arm group label: FES active
intervention type: Device
intervention name: Sham stimulation
arm group label: FES sham
arm group label: tDCS sham
criteria: 
gender: All
minimum age: 6 Months
maximum age: N/A
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: University of Nove de Julho
investigator full name: Aline Marina Alves Fruhauf
investigator title: Professor of graduation.
mesh term: Paresis