<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/NCT01701713</url>
  </required_header>
  <id_info>
    <org_study_id>TDCS_CSB-Brandenburg</org_study_id>
    <secondary_id>EA4/109/08</secondary_id>
    <nct_id>NCT01701713</nct_id>
  </id_info>
  <brief_title>TDCS in Acute Stroke</brief_title>
  <acronym>TDCS-aphasia</acronym>
  <official_title>Safety Study of Transcranial Direct Current Stimulation in Aphasia Therapy in Acute and Post-acute Stroke</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Charite University, Berlin, Germany</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>German Federal Ministry of Education and Research</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Brandenburg Klinik, Bernau, Germany</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Potsdam</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Charite University, Berlin, Germany</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine the safety of transcranial direct current&#xD;
      stimulation in aphasia therapy in acute and post-acute stroke.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      TDCS has been shown to have a positive effect on clinical outcome in both motor&#xD;
      rehabilitation and aphasia treatment in chronic aphasic patients. In healthy subjects the&#xD;
      method sped up reaction times in naming and language learning tasks. In TDCS a weak current&#xD;
      is applied to the subjects head increasing excitatory activity which might lead to improved&#xD;
      brain function.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>June 2009</start_date>
  <completion_date type="Anticipated">June 2013</completion_date>
  <primary_completion_date type="Anticipated">June 2013</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>Supportive Care</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>skin irritation</measure>
    <time_frame>2 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Improved language</measure>
    <time_frame>2 months</time_frame>
    <description>improved picture naming</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Stroke</condition>
  <arm_group>
    <arm_group_label>TDCS - DKI ED2011</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>TDCS with DKI ED2011 session is followed by a behavioral naming therapy with different cues</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sham-TDCS</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Sham-TDCS session is followed by a behavioral naming therapy with different cues</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>DKI ED2011</intervention_name>
    <arm_group_label>TDCS - DKI ED2011</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Sham-TDCS</intervention_name>
    <arm_group_label>Sham-TDCS</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  first media stroke&#xD;
&#xD;
          -  language impairment&#xD;
&#xD;
          -  informed consent&#xD;
&#xD;
          -  right handedness&#xD;
&#xD;
          -  NIHSS &lt; 20&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  previous Epilepsy oder epileptogenic events&#xD;
&#xD;
          -  epilepsy typical elements in EEG&#xD;
&#xD;
          -  hypersensitive skin (head)&#xD;
&#xD;
          -  metal implants (head)&#xD;
&#xD;
          -  pace maker or other electronic implants&#xD;
&#xD;
          -  previous head/brain surgery&#xD;
&#xD;
          -  medication reducing seizure threshold&#xD;
&#xD;
          -  previous psychiatric events&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gerhard J Jungehuelsing, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Center for Stroke Research Berlin (CSB), Charité</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Michael Joebges, Prof. MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Brandenburgklinik Bernau</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Gerhard J Jungehuelsing, MD</last_name>
    <email>jan.jungehuelsing@charite.de</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Isabell Wartenburger, Prof. MD</last_name>
    <email>isabell.wartenburger@uni-potsdam.de</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Brandenburg Klinik Bernau</name>
      <address>
        <city>Bernau</city>
        <state>Brandenburg</state>
        <zip>16321</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Michael Joebges, Prof. MD</last_name>
      <email>Joebges@Brandenburgklinik.de</email>
    </contact>
    <investigator>
      <last_name>Michael Joebges, Prof. MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Charité, Campus Benjamin Franklin, Dep. of Neurology</name>
      <address>
        <city>Berlin</city>
        <zip>12200</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>October 2012</verification_date>
  <study_first_submitted>September 26, 2012</study_first_submitted>
  <study_first_submitted_qc>October 4, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 5, 2012</study_first_posted>
  <last_update_submitted>October 5, 2012</last_update_submitted>
  <last_update_submitted_qc>October 5, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 8, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Charite University, Berlin, Germany</investigator_affiliation>
    <investigator_full_name>Gerhard Jan Jungehuelsing</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <keyword>TDCS</keyword>
  <keyword>STROKE</keyword>
  <keyword>APHASIA</keyword>
  <keyword>NAMING</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</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/NCT01701713
org study id: TDCS_CSB-Brandenburg
secondary id: EA4/109/08
nct id: NCT01701713
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
The purpose of this study is to determine the safety of transcranial direct current
      stimulation in aphasia therapy in acute and post-acute stroke.
TDCS has been shown to have a positive effect on clinical outcome in both motor
      rehabilitation and aphasia treatment in chronic aphasic patients. In healthy subjects the
      method sped up reaction times in naming and language learning tasks. In TDCS a weak current
      is applied to the subjects head increasing excitatory activity which might lead to improved
      brain function.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Double (Participant, Outcomes Assessor)
measure: skin irritation
time frame: 2 months
measure: Improved language
time frame: 2 months
description: improved picture naming
arm group label: TDCS - DKI ED2011
arm group type: Experimental
description: TDCS with DKI ED2011 session is followed by a behavioral naming therapy with different cues
arm group label: Sham-TDCS
arm group type: Sham Comparator
description: Sham-TDCS session is followed by a behavioral naming therapy with different cues
intervention type: Device
intervention name: DKI ED2011
arm group label: TDCS - DKI ED2011
intervention type: Device
intervention name: Sham-TDCS
arm group label: Sham-TDCS
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
last name: Gerhard J Jungehuelsing, MD
role: Principal Investigator
affiliation: Center for Stroke Research Berlin (CSB), Charité
last name: Michael Joebges, Prof. MD
role: Principal Investigator
affiliation: Brandenburgklinik Bernau
last name: Gerhard J Jungehuelsing, MD
email: jan.jungehuelsing@charite.de
last name: Isabell Wartenburger, Prof. MD
email: isabell.wartenburger@uni-potsdam.de
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Completed
country: Germany
responsible party type: Principal Investigator
investigator affiliation: Charite University, Berlin, Germany
investigator full name: Gerhard Jan Jungehuelsing
investigator title: MD
mesh term: Stroke