<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/NCT03305614</url>
  </required_header>
  <id_info>
    <org_study_id>BC-136-TVE</org_study_id>
    <nct_id>NCT03305614</nct_id>
  </id_info>
  <brief_title>tDCS and Aphasia Therapy in the Chronic Phase After Stroke</brief_title>
  <official_title>The Neuromodulatory Effect of Combined Transcranial Direct Current Stimulation With Intensive Aphasia Therapy in the Chronic Phase After Stroke</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Ghent</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University Hospital, Ghent</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University Hospital, Ghent</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>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study evaluates the neuromodulatory effect of combined tDCS and aphasia therapy in&#xD;
      patients in the chronic phase after stroke. Half of the participants will receive aphasia&#xD;
      therapy and tDCS, the other half will receive aphasia therapy and sham-tDCS.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Aphasia is present in about one third of all stroke patients in the chronic phase. The first&#xD;
      few months after stroke, considerable spontaneous recovery is initiated, including neuronal&#xD;
      plasticity and reorganization processes. Language recovery in aphasic stroke patients&#xD;
      involves reorganization of brain functions. Longitudinal fMRI studies reveal that the right&#xD;
      hemisphere shows increased activity at different times in the recovery process, but in the&#xD;
      long-term is correlated with poorer performance. Left re-lateralization, if possible, seems&#xD;
      to be the most effective in restoring language function. For a large subgroup of patients,&#xD;
      aphasia therapy is not sufficient to resolve language deficits and not all patients are&#xD;
      capable to endure intensive aphasia therapy. Therefore, non-invasive techniques (NIBS) such&#xD;
      as transcranial direct current stimulation (tDCS) are currently explored as an add-on&#xD;
      treatment to improve or accelerate therapy outcomes. tDCS is a painless and safe stimulation&#xD;
      tool that modulates cortical excitability through weak polarizing currents (1 mA - 2 mA)&#xD;
      between two electrodes. These weak currents are thought to induce a subthreshold shift of&#xD;
      resting membrane potentials towards depolarization or hyperpolarization. The effects of&#xD;
      stimulation depend on the polarity of the applied current relative to the axonal orientation.&#xD;
      It has been found that tDCS not only triggers immediate aftereffects, but also long-lasting&#xD;
      effects that persist beyond the stimulation time, even for up to 12 months. It was suggested&#xD;
      that long-term potentiation (LTP) and long-term depression (LTD) might be responsible for&#xD;
      these long-term effects, however the precise physiologic mechanisms of action are not yet&#xD;
      fully understood.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Reason unknown&#xD;
  </why_stopped>
  <start_date type="Actual">November 24, 2017</start_date>
  <completion_date type="Actual">April 18, 2018</completion_date>
  <primary_completion_date type="Actual">April 18, 2018</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in naming performance assessed with the Boston Naming Test</measure>
    <time_frame>baseline, 3 weeks, 3 +/-1 month</time_frame>
    <description>Naming performance will be assessed with the Boston Naming Test at baseline, immediately following therapy, and after 3 +/- 1 month following treatment</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in tolerability assessed with a Visual analogue scale</measure>
    <time_frame>baseline, 2 hour (each session)</time_frame>
    <description>A Visual analogue scale will asses tolerability before and immediately after each session</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in spontaneous speech assessed with a Semi-standardized interview of the AAT</measure>
    <time_frame>baseline, 3 weeks, 3 +/- 1 month</time_frame>
    <description>A Semi-standardized interview of the AAT will assess functional communication at baseline, immediately after therapy, and at 3 +/- 1 month follow-up</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in ERPs</measure>
    <time_frame>baseline, 3 weeks, 3 +/- 1 month</time_frame>
    <description>Evoked potentials will be measured at baseline, immediately after treatment and after 3 +/- 1 month</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in quality of life assessed with the SAQOL-39-NL</measure>
    <time_frame>baseline, 3 weeks, 3+/- 1 month</time_frame>
    <description>The SAQOL-39-NL will assess the quality of life at baseline, immediately after treatment and at 3 +/-1 month follow-up</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">25</enrollment>
  <condition>Aphasia Following Cerebral Infarction</condition>
  <condition>Aphasia Following Nontraumatic Intracerebral Hemorrhage</condition>
  <arm_group>
    <arm_group_label>Aphasia therapy and tDCS</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>combined tDCS and aphasia therapy and the effect of conventional intensive aphasia</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Aphasia therapy and sham-tDCS</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>computer-based intensive aphasia therapy as measured by specific linguistic tests</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>tDCS</intervention_name>
    <description>C-tDCS during the first 20 minutes of aphasia therapy, at an intensity of 1mA or sham-tDCS at an intensity of 0mA</description>
    <arm_group_label>Aphasia therapy and tDCS</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Aphasia therapy</intervention_name>
    <description>Based on linguistic tests, individualized aphasia therapy will be provided</description>
    <arm_group_label>Aphasia therapy and sham-tDCS</arm_group_label>
    <arm_group_label>Aphasia therapy and tDCS</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosed with mild to moderate aphasia (Token Test Score between 7 and 40) after a&#xD;
             first left hemispheric ischemic or hemorrhagic stroke&#xD;
&#xD;
          -  Inclusion &gt; 6 months post-stroke&#xD;
&#xD;
          -  Age 18 - 85 years&#xD;
&#xD;
          -  Being right-handed (&gt; +8 on the questionnaire for handedness, Van Strien)&#xD;
&#xD;
          -  Mothertongue: Dutch&#xD;
&#xD;
          -  Imaging (CT or MRI) prior to inclusion (in patient file), standard of care in the&#xD;
             acute phase&#xD;
&#xD;
          -  Signed Informed Consent (attachment 1)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of other diseases of the central nervous system, psychological disorders and&#xD;
             (developmental) speech and or language disorders&#xD;
&#xD;
          -  Serious non-linguistic, cognitive disorders (as documented in the patients' medical&#xD;
             history and inquired in the anamneses)&#xD;
&#xD;
          -  Prior brain surgery&#xD;
&#xD;
          -  Excessive use of alcohol or drugs&#xD;
&#xD;
          -  New neurological symptoms between the acute stage and inclusion&#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>Veerle De Herdt, Prof. Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Ghent</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Hospital Ghent</name>
      <address>
        <city>Ghent</city>
        <state>East-Flanders</state>
        <zip>9000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>September 28, 2017</study_first_submitted>
  <study_first_submitted_qc>October 9, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 10, 2017</study_first_posted>
  <last_update_submitted>November 29, 2022</last_update_submitted>
  <last_update_submitted_qc>November 29, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 2, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Aphasia</mesh_term>
    <mesh_term>Cerebral Hemorrhage</mesh_term>
    <mesh_term>Cerebral Infarction</mesh_term>
    <mesh_term>Infarction</mesh_term>
    <mesh_term>Hemorrhage</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/NCT03305614
org study id: BC-136-TVE
nct id: NCT03305614
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: Yes
This study evaluates the neuromodulatory effect of combined tDCS and aphasia therapy in
      patients in the chronic phase after stroke. Half of the participants will receive aphasia
      therapy and tDCS, the other half will receive aphasia therapy and sham-tDCS.
Aphasia is present in about one third of all stroke patients in the chronic phase. The first
      few months after stroke, considerable spontaneous recovery is initiated, including neuronal
      plasticity and reorganization processes. Language recovery in aphasic stroke patients
      involves reorganization of brain functions. Longitudinal fMRI studies reveal that the right
      hemisphere shows increased activity at different times in the recovery process, but in the
      long-term is correlated with poorer performance. Left re-lateralization, if possible, seems
      to be the most effective in restoring language function. For a large subgroup of patients,
      aphasia therapy is not sufficient to resolve language deficits and not all patients are
      capable to endure intensive aphasia therapy. Therefore, non-invasive techniques (NIBS) such
      as transcranial direct current stimulation (tDCS) are currently explored as an add-on
      treatment to improve or accelerate therapy outcomes. tDCS is a painless and safe stimulation
      tool that modulates cortical excitability through weak polarizing currents (1 mA - 2 mA)
      between two electrodes. These weak currents are thought to induce a subthreshold shift of
      resting membrane potentials towards depolarization or hyperpolarization. The effects of
      stimulation depend on the polarity of the applied current relative to the axonal orientation.
      It has been found that tDCS not only triggers immediate aftereffects, but also long-lasting
      effects that persist beyond the stimulation time, even for up to 12 months. It was suggested
      that long-term potentiation (LTP) and long-term depression (LTD) might be responsible for
      these long-term effects, however the precise physiologic mechanisms of action are not yet
      fully understood.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Change in naming performance assessed with the Boston Naming Test
time frame: baseline, 3 weeks, 3 +/-1 month
description: Naming performance will be assessed with the Boston Naming Test at baseline, immediately following therapy, and after 3 +/- 1 month following treatment
measure: Change in tolerability assessed with a Visual analogue scale
time frame: baseline, 2 hour (each session)
description: A Visual analogue scale will asses tolerability before and immediately after each session
measure: Change in spontaneous speech assessed with a Semi-standardized interview of the AAT
time frame: baseline, 3 weeks, 3 +/- 1 month
description: A Semi-standardized interview of the AAT will assess functional communication at baseline, immediately after therapy, and at 3 +/- 1 month follow-up
measure: Change in ERPs
time frame: baseline, 3 weeks, 3 +/- 1 month
description: Evoked potentials will be measured at baseline, immediately after treatment and after 3 +/- 1 month
measure: Change in quality of life assessed with the SAQOL-39-NL
time frame: baseline, 3 weeks, 3+/- 1 month
description: The SAQOL-39-NL will assess the quality of life at baseline, immediately after treatment and at 3 +/-1 month follow-up
arm group label: Aphasia therapy and tDCS
arm group type: Active Comparator
description: combined tDCS and aphasia therapy and the effect of conventional intensive aphasia
arm group label: Aphasia therapy and sham-tDCS
arm group type: Sham Comparator
description: computer-based intensive aphasia therapy as measured by specific linguistic tests
intervention type: Procedure
intervention name: tDCS
description: C-tDCS during the first 20 minutes of aphasia therapy, at an intensity of 1mA or sham-tDCS at an intensity of 0mA
arm group label: Aphasia therapy and tDCS
intervention type: Procedure
intervention name: Aphasia therapy
description: Based on linguistic tests, individualized aphasia therapy will be provided
arm group label: Aphasia therapy and sham-tDCS
arm group label: Aphasia therapy and tDCS
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
last name: Veerle De Herdt, Prof. Dr.
role: Principal Investigator
affiliation: University Ghent
facility: 
country: Belgium
responsible party type: Sponsor
mesh term: Aphasia
mesh term: Cerebral Hemorrhage
mesh term: Cerebral Infarction
mesh term: Infarction
mesh term: Hemorrhage
sharing ipd: No