<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/NCT02249819</url>
  </required_header>
  <id_info>
    <org_study_id>14-416</org_study_id>
    <nct_id>NCT02249819</nct_id>
  </id_info>
  <brief_title>Evaluating Anodal tDCS Preceding Aphasia Therapy</brief_title>
  <official_title>Evaluating Anodal tDCS Preceding Aphasia Therapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Northwell Health</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Northwell Health</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine if non-invasive brain stimulation (transcranial&#xD;
      direct current stimulation) delivered prior to language therapy will improve word-finding in&#xD;
      individuals with aphasia who are 6 months or greater post-stroke.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <start_date type="Actual">September 2014</start_date>
  <completion_date type="Actual">November 2017</completion_date>
  <primary_completion_date type="Actual">June 2017</primary_completion_date>
  <phase>Phase 1/Phase 2</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>
    <intervention_model_description>All participants received both stimulation conditions (active tDCS + computerized naming therapy and sham tDCS + computerized naming therapy), separated by a 1-week washout period.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    <masking_description>Sequence of stimulation conditions was randomized across subjects.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Mean Change in Picture-naming Accuracy Score</measure>
    <time_frame>baseline, discharge</time_frame>
    <description>The mean change in verbal picture-naming accuracy score (out of 75) was calculated from baseline to discharge in each condition (sham and active tDCS).</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">15</enrollment>
  <condition>Stroke</condition>
  <condition>Aphasia</condition>
  <arm_group>
    <arm_group_label>anodal tDCS, then sham tDCS</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants received 1 single 20 min session of anodal tDCS + computerized naming therapy. Following a 1 week washout period, they received 1 single 20 min session of sham tDCS + computerized aphasia therapy. Sequence of stimulation conditions was randomized across participants.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>sham tDCS, then anodal tDCS</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants received 1 single 20 min session of sham tDCS + computerized naming therapy. Following a 1 week washout period, they received 1 single 20 min session of anodal tDCS + computerized aphasia therapy. Sequence of stimulation conditions was randomized across participants.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>transcranial direct current stimulation</intervention_name>
    <description>Soterix 1x1 anodal tDCS</description>
    <arm_group_label>anodal tDCS, then sham tDCS</arm_group_label>
    <arm_group_label>sham tDCS, then anodal tDCS</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. ≥ 18 years of age&#xD;
&#xD;
          2. First single focal unilateral left hemisphere lesion with diagnosis verified by brain&#xD;
             imaging (MRI or CT scans) that occurred at least 6 months prior&#xD;
&#xD;
          3. Pre-morbidly right handed&#xD;
&#xD;
          4. Pre-morbidly fluent English speaker&#xD;
&#xD;
          5. Cognitive function sufficient to understand the experiments and follow instructions&#xD;
             (per interview with Speech Pathologist)&#xD;
&#xD;
          6. A baseline Aphasia Quotient score between 10 to 94 out of 100 points on the Western&#xD;
             Aphasia Battery (neither completely without language comprehension/expression nor&#xD;
             fully recovered from aphasia).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Ongoing use of CNS-active medications&#xD;
&#xD;
          2. Ongoing use of psychoactive medications, such as stimulants, antidepressants, and&#xD;
             anti-psychotic medications&#xD;
&#xD;
          3. Presence of additional potential tDCS risk factors:&#xD;
&#xD;
               -  Damaged skin at the site of stimulation (i.e., skin with ingrown hairs, acne,&#xD;
                  razor nicks, wounds that have not healed, recent scar tissue, broken skin, etc.)&#xD;
&#xD;
               -  Presence of an electrically, magnetically or mechanically activated implant&#xD;
                  (including cardiac pacemaker), an intracerebral vascular clip, or any other&#xD;
                  electrically sensitive support system&#xD;
&#xD;
               -  Metal in any part of the body, including metal injury to the eye (jewelry must be&#xD;
                  removed during stimulation)&#xD;
&#xD;
               -  A history of medication-resistant epilepsy in the family&#xD;
&#xD;
               -  Past history of seizures or unexplained spells of loss of consciousness during&#xD;
                  the previous 36 months&#xD;
&#xD;
          4. Pregnancy in women, as determined by self-report&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Feinstein Institute for Medical Research</name>
      <address>
        <city>Manhasset</city>
        <state>New York</state>
        <zip>11030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Monti A, Cogiamanian F, Marceglia S, Ferrucci R, Mameli F, Mrakic-Sposta S, Vergari M, Zago S, Priori A. Improved naming after transcranial direct current stimulation in aphasia. J Neurol Neurosurg Psychiatry. 2008 Apr;79(4):451-3. doi: 10.1136/jnnp.2007.135277. Epub 2007 Dec 20.</citation>
    <PMID>18096677</PMID>
  </reference>
  <reference>
    <citation>Baker JM, Rorden C, Fridriksson J. Using transcranial direct-current stimulation to treat stroke patients with aphasia. Stroke. 2010 Jun;41(6):1229-36. doi: 10.1161/STROKEAHA.109.576785. Epub 2010 Apr 15.</citation>
    <PMID>20395612</PMID>
  </reference>
  <reference>
    <citation>Fiori V, Coccia M, Marinelli CV, Vecchi V, Bonifazi S, Ceravolo MG, Provinciali L, Tomaiuolo F, Marangolo P. Transcranial direct current stimulation improves word retrieval in healthy and nonfluent aphasic subjects. J Cogn Neurosci. 2011 Sep;23(9):2309-23. doi: 10.1162/jocn.2010.21579. Epub 2010 Oct 14.</citation>
    <PMID>20946060</PMID>
  </reference>
  <reference>
    <citation>Holland R, Crinion J. Can tDCS enhance treatment of aphasia after stroke? Aphasiology. 2012 Sep;26(9):1169-1191. doi: 10.1080/02687038.2011.616925. Epub 2011 Nov 3.</citation>
    <PMID>23060684</PMID>
  </reference>
  <reference>
    <citation>Marangolo P, Fiori V, Campana S, Calpagnano MA, Razzano C, Caltagirone C, Marini A. Something to talk about: enhancement of linguistic cohesion through tdCS in chronic non fluent aphasia. Neuropsychologia. 2014 Jan;53:246-56. doi: 10.1016/j.neuropsychologia.2013.12.003. Epub 2013 Dec 11.</citation>
    <PMID>24333381</PMID>
  </reference>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>September 23, 2014</study_first_submitted>
  <study_first_submitted_qc>September 23, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 26, 2014</study_first_posted>
  <results_first_submitted>February 1, 2018</results_first_submitted>
  <results_first_submitted_qc>March 9, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">April 6, 2018</results_first_posted>
  <last_update_submitted>March 8, 2021</last_update_submitted>
  <last_update_submitted_qc>March 8, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 5, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Northwell Health</investigator_affiliation>
    <investigator_full_name>Bruce Volpe</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>stroke</keyword>
  <keyword>aphasia</keyword>
  <keyword>CVA</keyword>
  <keyword>apraxia</keyword>
  <keyword>cerebrovascular accident</keyword>
  <keyword>cerebral stroke</keyword>
  <keyword>speech therapy</keyword>
  <keyword>aphasia therapy</keyword>
  <keyword>non-invasive brain stimulation</keyword>
  <keyword>transcranial direct current stimulation</keyword>
  <keyword>tDCS</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Aphasia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>July 27, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/19/NCT02249819/Prot_SAP_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>July 25, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/19/NCT02249819/ICF_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>All participants received both the active and sham tDCS conditions, and sequence of stimulation conditions was randomized across participants.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Anodal tDCS, Then Sham tDCS</title>
          <description>Participants first received 1 single 20 min session of anodal tDCS + computerized naming therapy. After a washout period of 1 week, they then received 1 single 20 min session of sham tDCS + computerized naming therapy.</description>
        </group>
        <group group_id="P2">
          <title>Sham tDCS, Then Anodal tDCS</title>
          <description>Participants first received 1 single 20 min session of sham tDCS + computerized naming therapy. After a washout period of 1 week, they then received 1 single 20 min session of anodal tDCS + computerized naming therapy.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="7"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="7"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>All Study Participants</title>
          <description>Crossover design study: All participants were randomized to receive one single 20 min session of anodal tDCS and 1 single session of sham tDCS followed by computerized naming therapy. Sequence of stimulation conditions was counterbalanced across participants with a 1 week washout period in between conditions.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="15"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Mean Change in Picture-naming Accuracy Score</title>
        <description>The mean change in verbal picture-naming accuracy score (out of 75) was calculated from baseline to discharge in each condition (sham and active tDCS).</description>
        <time_frame>baseline, discharge</time_frame>
        <population>All participants received one dose of each intervention and completed all study visits. They were consequently all included in the efficacy analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Anodal tDCS</title>
            <description>Participants received 1 single 20 min session of anodal tDCS + computerized naming therapy in either the first two or the last two weeks of the study.</description>
          </group>
          <group group_id="O2">
            <title>Sham tDCS</title>
            <description>Participants received 1 single 20 min session of sham tDCS + computerized naming therapy in either the first two or the last two weeks of the study.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change in Picture-naming Accuracy Score</title>
          <description>The mean change in verbal picture-naming accuracy score (out of 75) was calculated from baseline to discharge in each condition (sham and active tDCS).</description>
          <population>All participants received one dose of each intervention and completed all study visits. They were consequently all included in the efficacy analysis.</population>
          <units>score</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Mean Score at Discharge(out of 75)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="51.33" spread="17.79"/>
                    <measurement group_id="O2" value="51.00" spread="18.40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Mean Change from Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.25" spread="4.85"/>
                    <measurement group_id="O2" value="5.92" spread="5.21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Equivalence</non_inferiority_type>
            <non_inferiority_desc>Statistical analysis for mean change from baseline in naming accuracy in the anodal vs. sham tDCS conditions Null hypothesis is that there was no difference in mean change of naming accuracy between anodal and sham tDCS conditions. A significance level of 0.05 was used (two-sided).</non_inferiority_desc>
            <p_value>0.694</p_value>
            <p_value_desc>The wilcoxon sign-ranked test was performed for this crossover design study in which subjects underwent measures across 2 study conditions (paired samples: mean change in anodal vs. sham condition). A significance level of 0.05 was used (two-sided).</p_value_desc>
            <method>wilcoxon sign-ranked test</method>
            <method_desc>Western Aphasia Battery used as a screening tool on admission only, to characterize level of severity. It was NOT an outcome measure.</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Two weeks for each intervention</time_frame>
      <desc>Safety population included all participants who received at least one dose of intervention.</desc>
      <group_list>
        <group group_id="E1">
          <title>Anodal tDCS</title>
          <description>Participants who received anodal tDCS + computerized picture-naming therapy, and were followed for 2 weeks.</description>
        </group>
        <group group_id="E2">
          <title>Sham tDCS</title>
          <description>Participants who received sham tDCS + computerized picture-naming therapy, and were followed for 2 weeks.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Johanna Chang, Senior Research Coordinator</name_or_title>
      <organization>Northwell Health</organization>
      <phone>(516)562-3646</phone>
      <email>jchang14@northwell.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02249819
org study id: 14-416
nct id: NCT02249819
lead sponsor: 
has dmc: No
The purpose of this study is to determine if non-invasive brain stimulation (transcranial
      direct current stimulation) delivered prior to language therapy will improve word-finding in
      individuals with aphasia who are 6 months or greater post-stroke.
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: All participants received both stimulation conditions (active tDCS + computerized naming therapy and sham tDCS + computerized naming therapy), separated by a 1-week washout period.
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
masking description: Sequence of stimulation conditions was randomized across subjects.
measure: Mean Change in Picture-naming Accuracy Score
time frame: baseline, discharge
description: The mean change in verbal picture-naming accuracy score (out of 75) was calculated from baseline to discharge in each condition (sham and active tDCS).
arm group label: anodal tDCS, then sham tDCS
arm group type: Experimental
description: Participants received 1 single 20 min session of anodal tDCS + computerized naming therapy. Following a 1 week washout period, they received 1 single 20 min session of sham tDCS + computerized aphasia therapy. Sequence of stimulation conditions was randomized across participants.
arm group label: sham tDCS, then anodal tDCS
arm group type: Experimental
description: Participants received 1 single 20 min session of sham tDCS + computerized naming therapy. Following a 1 week washout period, they received 1 single 20 min session of anodal tDCS + computerized aphasia therapy. Sequence of stimulation conditions was randomized across participants.
intervention type: Device
intervention name: transcranial direct current stimulation
description: Soterix 1x1 anodal tDCS
arm group label: anodal tDCS, then sham tDCS
arm group label: sham tDCS, then anodal tDCS
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
citation: Monti A, Cogiamanian F, Marceglia S, Ferrucci R, Mameli F, Mrakic-Sposta S, Vergari M, Zago S, Priori A. Improved naming after transcranial direct current stimulation in aphasia. J Neurol Neurosurg Psychiatry. 2008 Apr;79(4):451-3. doi: 10.1136/jnnp.2007.135277. Epub 2007 Dec 20.
PMID: 18096677
citation: Baker JM, Rorden C, Fridriksson J. Using transcranial direct-current stimulation to treat stroke patients with aphasia. Stroke. 2010 Jun;41(6):1229-36. doi: 10.1161/STROKEAHA.109.576785. Epub 2010 Apr 15.
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responsible party type: Principal Investigator
investigator affiliation: Northwell Health
investigator full name: Bruce Volpe
investigator title: Principal Investigator
mesh term: Aphasia
sharing ipd: Undecided
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