<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/NCT03297450</url>
  </required_header>
  <id_info>
    <org_study_id>EC2017/0906</org_study_id>
    <nct_id>NCT03297450</nct_id>
  </id_info>
  <brief_title>tDCS and Aphasia Therapy in the Acute Phase After Stroke</brief_title>
  <official_title>The Neuromodulatory Effect of Combined Transcranial Direct Current Stimulation (tDCS) With Aphasia Therapy in the Acute Phase After Ischemic 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 acute stage 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 acute 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>
    Difficult patient recruitment&#xD;
  </why_stopped>
  <start_date type="Actual">October 2, 2017</start_date>
  <completion_date type="Actual">March 30, 2018</completion_date>
  <primary_completion_date type="Actual">March 30, 2018</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>
    <intervention_model_description>aphasia therapy (45 minutes) in combination with (sham or real) tDCS (20 minutes)</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in naming performance</measure>
    <time_frame>baseline, 1 week, 3 months, 6 months</time_frame>
    <description>Naming performance will be assessed with the Boston Naming Test at baseline, immediately following therapy, and after 3 and 6 months</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Vital Parameters</measure>
    <time_frame>baseline, 1 hour (each session)</time_frame>
    <description>Blood pressure and heart rate will be measured before and after each session of treatment</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in tolerability (Visual analogue scale)</measure>
    <time_frame>baseline, 1 hour (each session)</time_frame>
    <description>A Visual analogue scale will assess tolerability before and immediately after each session</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Spontaneous Speech</measure>
    <time_frame>baseline, 1 week, 3 months, 6 months</time_frame>
    <description>A Semi-standardized interview of the AAT will assess functional communication at baseline, immediately after therapy, and at 3 and 6 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in ERPs</measure>
    <time_frame>baseline, 1 week, 3 months, 6 months</time_frame>
    <description>Evoked potentials will be measured at baseline, immediately after treatment and after 3 and 6 months</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">1</enrollment>
  <condition>Aphasia Following Cerebral Infarction</condition>
  <arm_group>
    <arm_group_label>Aphasia therapy and tDCS</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Aphasia therapy and sham-tDCS</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard of care and sham-tDCS</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>tDCS</intervention_name>
    <description>C-tDCS during the first 20 minutes of aphasia therapy, at an intensity of 1mA</description>
    <arm_group_label>Aphasia therapy and tDCS</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</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>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Sham-tDCS</intervention_name>
    <description>tDCS during the first 20 minutes of aphasia therapy at an intensity of 0mA (Sham)</description>
    <arm_group_label>Aphasia therapy and sham-tDCS</arm_group_label>
    <arm_group_label>Standard of care and sham-tDCS</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosed with mild-moderate aphasia (Token Test Score between 7 and 40)&#xD;
&#xD;
          -  Inclusion in the first few days after stroke (acute phase)&#xD;
&#xD;
          -  Age 18 - 85 years&#xD;
&#xD;
          -  Being right-handed&#xD;
&#xD;
          -  Mothertongue: Dutch&#xD;
&#xD;
          -  Able to undergo functional and specific linguistic testing and therapy in the acute&#xD;
             phase following stroke&#xD;
&#xD;
          -  Imaging (CT or MRI) prior to inclusion (standard of care)&#xD;
&#xD;
          -  Signed Informed Consent&#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 anamneses)&#xD;
&#xD;
          -  Prior brain surgery&#xD;
&#xD;
          -  Excessive use of alcohol or drugs&#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>January 2023</verification_date>
  <study_first_submitted>September 5, 2017</study_first_submitted>
  <study_first_submitted_qc>September 28, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 29, 2017</study_first_posted>
  <last_update_submitted>January 6, 2023</last_update_submitted>
  <last_update_submitted_qc>January 6, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 10, 2023</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 Infarction</mesh_term>
    <mesh_term>Infarction</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/NCT03297450
org study id: EC2017/0906
nct id: NCT03297450
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 acute stage 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 acute 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
intervention model description: aphasia therapy (45 minutes) in combination with (sham or real) tDCS (20 minutes)
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Change in naming performance
time frame: baseline, 1 week, 3 months, 6 months
description: Naming performance will be assessed with the Boston Naming Test at baseline, immediately following therapy, and after 3 and 6 months
measure: Change in Vital Parameters
time frame: baseline, 1 hour (each session)
description: Blood pressure and heart rate will be measured before and after each session of treatment
measure: Change in tolerability (Visual analogue scale)
time frame: baseline, 1 hour (each session)
description: A Visual analogue scale will assess tolerability before and immediately after each session
measure: Change in Spontaneous Speech
time frame: baseline, 1 week, 3 months, 6 months
description: A Semi-standardized interview of the AAT will assess functional communication at baseline, immediately after therapy, and at 3 and 6 months
measure: Change in ERPs
time frame: baseline, 1 week, 3 months, 6 months
description: Evoked potentials will be measured at baseline, immediately after treatment and after 3 and 6 months
arm group label: Aphasia therapy and tDCS
arm group type: Active Comparator
arm group label: Aphasia therapy and sham-tDCS
arm group type: Sham Comparator
arm group label: Standard of care and sham-tDCS
arm group type: Sham Comparator
intervention type: Device
intervention name: tDCS
description: C-tDCS during the first 20 minutes of aphasia therapy, at an intensity of 1mA
arm group label: Aphasia therapy and tDCS
intervention type: Behavioral
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
intervention type: Device
intervention name: Sham-tDCS
description: tDCS during the first 20 minutes of aphasia therapy at an intensity of 0mA (Sham)
arm group label: Aphasia therapy and sham-tDCS
arm group label: Standard of care and sham-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 Infarction
mesh term: Infarction
sharing ipd: No