<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/NCT03820843</url>
  </required_header>
  <id_info>
    <org_study_id>APHP180312</org_study_id>
    <secondary_id>N° IDRCB: 2018-A02462-53</secondary_id>
    <nct_id>NCT03820843</nct_id>
  </id_info>
  <brief_title>Impact of Art Therapy on Brain Connectivity in Recent Post-Stroke Aphasia</brief_title>
  <acronym>ART-CONNECT</acronym>
  <official_title>Impact of Art Therapy on Brain Connectivity in Recent Post-Stroke Aphasia (ART-CONNECT)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assistance Publique - Hôpitaux de Paris</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assistance Publique - Hôpitaux de Paris</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      A stroke located in the left parieto-temporal junction is associated, in aphasic right-handed&#xD;
      patients, with a poor prognosis for language recovery. The role of the right hemisphere in&#xD;
      recovering post-stroke aphasia is still controversial. Our hypothesis, based on recent work&#xD;
      in imaging, is that early activation of the right hemisphere linked to the practice of the&#xD;
      visual arts could facilitate language recovery in extended posterior left strokes that&#xD;
      completely disrupt language areas.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators will evaluate, at inclusion and at 6 weeks, the reorganization of&#xD;
      functional and structural brain connectivity maps before and after rehabilitation of aphasia&#xD;
      with art therapy and standard orthophonic rehabilitation versus a control group that received&#xD;
      only standard orthophonic rehabilitation.&#xD;
&#xD;
      The investigators will include all consecutive patients with recent ischemic or hemorrhagic&#xD;
      stroke with unilateral lesion(s) of the parieto-temporal left junction present on the&#xD;
      Diffusion MRI (DWI) performed in acute phase at 24-48h.&#xD;
&#xD;
      All patients will undergo 2 MRI with tensor diffusion sequences (structural connectivity) and&#xD;
      fMRI (functional magnetic resonance imaging) resting state sequences (functional&#xD;
      connectivity) at inclusion and 6 weeks after rehabilitation with or without art therapy.&#xD;
&#xD;
      The investigators aimed to demonstrate that early activation of the right hemisphere related&#xD;
      to the practice of the visual arts could facilitate the recovery of language in later strokes&#xD;
      completely disrupting the language areas of the left hemisphere.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">February 17, 2020</start_date>
  <completion_date type="Anticipated">February 2, 2022</completion_date>
  <primary_completion_date type="Anticipated">February 2, 2022</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>The investigators will evaluate the reorganization of functional and structural brain connectivity maps before and after rehabilitation of aphasia with art therapy and standard orthophonic rehabilitation versus a control group that received only standard orthophonic rehabilitation.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
    <masking_description>Single-blind: only the art therapist knows the randomization arm. The investigators involved in the outcomes assessement, will remain blinded with regard to the randomized treatment assignments</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>change from baseline measurement of white substance bundles volumes for structural connectivity at 6 weeks</measure>
    <time_frame>from inclusion at 6 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>change from baseline measurement of synchrony amplitude of slow fluctuations for functional Connectivity at 6 weeks</measure>
    <time_frame>from inclusion at 6 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>change from baseline Aphasia at 6 weeks</measure>
    <time_frame>from inclusion at 6 weeks</time_frame>
    <description>The BDAE (Boston Diagnostic Aphasia Examination) score ranges from 0 to 5, with higher values indicating more severe impairment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change from baseline Aphasia at 6 weeks</measure>
    <time_frame>from inclusion at 6 weeks</time_frame>
    <description>The ART (Aphasia Rapid Test) score ranges from 0 to 26, with higher values indicating more severe impairment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change from baseline Anxiety and depression at 6 weeks</measure>
    <time_frame>from inclusion and at 6 weeks</time_frame>
    <description>The HADS (Hospital Anxiety and Depression Scale) scores ranges from 0 to 21 for both anxiety and depression scores, with higher values indicating more severe impairment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change from baseline Quality of life self-assessment at 6 weeks</measure>
    <time_frame>from inclusion at 6 weeks</time_frame>
    <description>Visual Analogic scale of patient quality of life is a 0% to 100% scale, with 100 indicating the best health status</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Satisfaction self-assessment at 6 weeks</measure>
    <time_frame>at 6 weeks only</time_frame>
    <description>visual analogic scale of patient satisfaction is a 0 to 10 scale, with higher values indicating better satisfaction</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Ischemic or Hemorrhagic Stroke</condition>
  <arm_group>
    <arm_group_label>Art therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Art therapy and standard orthophonic rehabilitation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Only standard orthophonic rehabilitation</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Art therapy and standard orthophonic rehabilitation</intervention_name>
    <description>In addition to standard orthophonic rehabilitation, the patient will receive 12 sessions of art therapy</description>
    <arm_group_label>Art therapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with recent ischemic or haemorrhagic stroke with unilateral lesion (s) of the&#xD;
             parieto-temporal left junction present on the Diffusion MRI (DWI) performed in acute&#xD;
             phase at 24-48h&#xD;
&#xD;
          -  Post stroke delay of 15 days to 2 months&#xD;
&#xD;
          -  Existence of moderate to severe phasic disorders on Aphasia Rapid Test score (ART,&#xD;
             score&gt; 6, scale of 26 items)&#xD;
&#xD;
          -  Patient able to read and understand French&#xD;
&#xD;
          -  Rightful&#xD;
&#xD;
          -  Normal and corrected vision and hearing&#xD;
&#xD;
          -  Absence of pre-existing degenerative neurological disorder&#xD;
&#xD;
          -  Patient having signed his consent&#xD;
&#xD;
          -  Age ≥ 18 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with contraindications to MRI or claustrophobic&#xD;
&#xD;
          -  Patients under legal protection&#xD;
&#xD;
          -  Patients with behavioral disorders or disabling neurovisual disorders making&#xD;
             participation in art therapy impossible&#xD;
&#xD;
          -  Mute patients, illiterate patients&#xD;
&#xD;
          -  Patients leaving the neurological SSR department prematurely&#xD;
&#xD;
          -  Patients not affiliated to a social security scheme&#xD;
&#xD;
          -  Pregnant or lactating women.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sophie Dupont</last_name>
    <role>Principal Investigator</role>
    <affiliation>Assistance Publique - Hôpitaux de Paris</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Sophie Dupont</last_name>
    <phone>0142160301</phone>
    <email>sophie.dupont@aphp.fr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Anne Bissery</last_name>
    <phone>0142162432</phone>
    <email>anne.bissery@aphp.fr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Groupe Hospitalier Pitié-Salpêtrière, Soins de Suite et Réadaptation</name>
      <address>
        <city>Paris</city>
        <zip>75013</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>January 10, 2019</study_first_submitted>
  <study_first_submitted_qc>January 25, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 29, 2019</study_first_posted>
  <last_update_submitted>January 24, 2021</last_update_submitted>
  <last_update_submitted_qc>January 24, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 26, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>brain connectivity</keyword>
  <keyword>aphasia</keyword>
  <keyword>art therapy</keyword>
  <keyword>rehabilitation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</mesh_term>
    <mesh_term>Aphasia</mesh_term>
    <mesh_term>Hemorrhagic Stroke</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/NCT03820843
org study id: APHP180312
secondary id: N° IDRCB: 2018-A02462-53
nct id: NCT03820843
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
A stroke located in the left parieto-temporal junction is associated, in aphasic right-handed
      patients, with a poor prognosis for language recovery. The role of the right hemisphere in
      recovering post-stroke aphasia is still controversial. Our hypothesis, based on recent work
      in imaging, is that early activation of the right hemisphere linked to the practice of the
      visual arts could facilitate language recovery in extended posterior left strokes that
      completely disrupt language areas.
The investigators will evaluate, at inclusion and at 6 weeks, the reorganization of
      functional and structural brain connectivity maps before and after rehabilitation of aphasia
      with art therapy and standard orthophonic rehabilitation versus a control group that received
      only standard orthophonic rehabilitation.

      The investigators will include all consecutive patients with recent ischemic or hemorrhagic
      stroke with unilateral lesion(s) of the parieto-temporal left junction present on the
      Diffusion MRI (DWI) performed in acute phase at 24-48h.

      All patients will undergo 2 MRI with tensor diffusion sequences (structural connectivity) and
      fMRI (functional magnetic resonance imaging) resting state sequences (functional
      connectivity) at inclusion and 6 weeks after rehabilitation with or without art therapy.

      The investigators aimed to demonstrate that early activation of the right hemisphere related
      to the practice of the visual arts could facilitate the recovery of language in later strokes
      completely disrupting the language areas of the left hemisphere.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: The investigators will evaluate the reorganization of functional and structural brain connectivity maps before and after rehabilitation of aphasia with art therapy and standard orthophonic rehabilitation versus a control group that received only standard orthophonic rehabilitation.
primary purpose: Treatment
masking: Double (Investigator, Outcomes Assessor)
masking description: Single-blind: only the art therapist knows the randomization arm. The investigators involved in the outcomes assessement, will remain blinded with regard to the randomized treatment assignments
measure: change from baseline measurement of white substance bundles volumes for structural connectivity at 6 weeks
time frame: from inclusion at 6 weeks
measure: change from baseline measurement of synchrony amplitude of slow fluctuations for functional Connectivity at 6 weeks
time frame: from inclusion at 6 weeks
measure: change from baseline Aphasia at 6 weeks
time frame: from inclusion at 6 weeks
description: The BDAE (Boston Diagnostic Aphasia Examination) score ranges from 0 to 5, with higher values indicating more severe impairment
measure: change from baseline Aphasia at 6 weeks
time frame: from inclusion at 6 weeks
description: The ART (Aphasia Rapid Test) score ranges from 0 to 26, with higher values indicating more severe impairment
measure: change from baseline Anxiety and depression at 6 weeks
time frame: from inclusion and at 6 weeks
description: The HADS (Hospital Anxiety and Depression Scale) scores ranges from 0 to 21 for both anxiety and depression scores, with higher values indicating more severe impairment
measure: change from baseline Quality of life self-assessment at 6 weeks
time frame: from inclusion at 6 weeks
description: Visual Analogic scale of patient quality of life is a 0% to 100% scale, with 100 indicating the best health status
measure: Satisfaction self-assessment at 6 weeks
time frame: at 6 weeks only
description: visual analogic scale of patient satisfaction is a 0 to 10 scale, with higher values indicating better satisfaction
arm group label: Art therapy
arm group type: Experimental
description: Art therapy and standard orthophonic rehabilitation
arm group label: Control group
arm group type: No Intervention
description: Only standard orthophonic rehabilitation
intervention type: Other
intervention name: Art therapy and standard orthophonic rehabilitation
description: In addition to standard orthophonic rehabilitation, the patient will receive 12 sessions of art therapy
arm group label: Art therapy
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Sophie Dupont
role: Principal Investigator
affiliation: Assistance Publique - Hôpitaux de Paris
last name: Sophie Dupont
phone: 0142160301
email: sophie.dupont@aphp.fr
last name: Anne Bissery
phone: 0142162432
email: anne.bissery@aphp.fr
facility: 
status: Recruiting
country: France
responsible party type: Sponsor
mesh term: Stroke
mesh term: Aphasia
mesh term: Hemorrhagic Stroke
sharing ipd: No