<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/NCT02213640</url>
  </required_header>
  <id_info>
    <org_study_id>2013-803</org_study_id>
    <nct_id>NCT02213640</nct_id>
  </id_info>
  <brief_title>Potentiation of the Effects of Prismatic Adaptation by Transcranial Direct Current Stimulation (tDCS) : Evaluation of Functional Interest in Negligence Rehabilitation</brief_title>
  <acronym>PRIStiM1</acronym>
  <official_title>Potentiation of the Effects of Prismatic Adaptation by Transcranial Direct Current Stimulation (tDCS) : Evaluation of Functional Interest in Negligence Rehabilitation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospices Civils de Lyon</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospices Civils de Lyon</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Following stroke, over 50% of patients keep severe neurological deficiency whose unilateral&#xD;
      neglect, mostly following a right hemispheric lesion. The prismatic adaptation involves to&#xD;
      pointing movements toward visual targets wearing prismatic glasses. These prismatic glasses&#xD;
      induce a shift to the right visual field for improving symptoms in short term.&#xD;
&#xD;
      Transcranial direct stimulation (tDCS) has been evaluated for different types of deficiency&#xD;
      resulting from stroke with encouraging results. The hypothesis of the study is to evaluate&#xD;
      the usefulness of brain stimulation as an adjunctive intervention to optimize and increase&#xD;
      the rehabilitation of unilateral neglect to long-term.&#xD;
&#xD;
      Thus, the main objective is to evaluate the effectiveness of standard treatment with&#xD;
      prismatic adaptation with anodal tDCS or sham tDCS.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 26, 2014</start_date>
  <completion_date type="Actual">May 25, 2018</completion_date>
  <primary_completion_date type="Actual">May 25, 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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Behavioural Inattention Test (BIT)</measure>
    <time_frame>Change in BIT score between the baseline sessions average and score measured at week 11</time_frame>
    <description>assessed at two baseline sessions before intervention (inclusion and week 3), and after the therapeutic intervention week (week 5), 2 weeks (week 7), 6 weeks (week 11) and 15 weeks (week 20) following the inclusion.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Negligence Battery Test (BTN)</measure>
    <time_frame>before intervention (week 1 and week 3), and then again following the intervention (week 5), 2 weeks (week 7), 6 weeks (week 11) and 15 weeks (week 20)</time_frame>
    <description>Change in BTN scores between baseline measures before the therapeutic intervention week and scores obtained during each follow-up sessions</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Functional independence scale (MIF)</measure>
    <time_frame>before intervention (week 1 and week 3), and then again following the intervention (week 5), 2 weeks (week 7), 6 weeks (week 11) and 15 weeks (week 20)</time_frame>
    <description>Change in MIF scores between baseline measures before the therapeutic intervention week and scores obtained during each follow-up sessions</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Catherine Bergego scale (ECB)</measure>
    <time_frame>baseline session before intervention (week 1 and week 3), and then again following the intervention (week 5), 2 weeks (week 7), 6 weeks (week 11) and 15 weeks (week 20)</time_frame>
    <description>Change in ECB scores between baseline measures before the therapeutic intervention week and scores obtained during each follow-up sessions</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Jamar</measure>
    <time_frame>baseline session before intervention (week 1 and week 3), and then again following the intervention (week 5), 2 weeks (week 7), 6 weeks (week 11) and 15 weeks (week 20)</time_frame>
    <description>Change in Jamar scores between baseline measures before the therapeutic intervention week and scores obtained during each follow-up sessions</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">24</enrollment>
  <condition>Neurologic Neglect Syndrome</condition>
  <arm_group>
    <arm_group_label>Arm A Anodal tDCS and prismatic adaptation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>anodal tDCS over the primary motor cortex : stimulation intensity of 1mA during 20 minutes (5 consecutive sessions during one week).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm B: control</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Prismatic adaptation with placebo stimulation</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>transcranial direct current stimulation (tDCS)</intervention_name>
    <description>Anodal tDCS over the primary motor cortex. Stimulation intensity of 1mA during 20 minutes (5 consecutive sessions during one week).</description>
    <arm_group_label>Arm A Anodal tDCS and prismatic adaptation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Control: placebo stimulation</intervention_name>
    <description>electrode of sham tDCS over the primary motor cortex during 20 minutes (5 consecutive sessions during one week).</description>
    <arm_group_label>Arm B: control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Right-handed&#xD;
&#xD;
          -  All subjects must be between the ages of 18-80&#xD;
&#xD;
          -  Patient with unilateral negligence consecutive to a right hemispheric stroke&#xD;
&#xD;
          -  Hospitalized in the Department of Physical Medicine and Rehabilitation (day or week)&#xD;
             or external monitoring&#xD;
&#xD;
          -  Ischemic or hemorrhagic stroke with right hemispheric topography - evidenced by a&#xD;
             radiological report&#xD;
&#xD;
          -  Diagnosis of negligence evidenced by Behavioural Inattention Test (BIT) : score ≤ 129&#xD;
&#xD;
          -  Stroke &gt;1 month prior to study enrollment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Degenerative neurological complaint&#xD;
&#xD;
          -  Uncontrolled epilepsy&#xD;
&#xD;
          -  Temporo-spatial disorientation&#xD;
&#xD;
          -  Language disorders or psychiatric disorders preventing understanding instructions&#xD;
&#xD;
          -  History of prior stroke, multiple stroke&#xD;
&#xD;
          -  Medical condition not stabilized&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Implanted material (pacemaker, defibrillator, cochlear implant, surgical clips, metal&#xD;
             object)&#xD;
&#xD;
          -  Intra-cranial material&#xD;
&#xD;
          -  Unweaned alcoholism&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sophie JACQUIN-COURTOIS, MD-PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospices Civils de Lyon</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hôpital henri Gabriel (Hospices Civils de Lyon)</name>
      <address>
        <city>Saint-Genis Laval</city>
        <zip>69230</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>August 2018</verification_date>
  <study_first_submitted>August 8, 2014</study_first_submitted>
  <study_first_submitted_qc>August 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 11, 2014</study_first_posted>
  <last_update_submitted>August 13, 2018</last_update_submitted>
  <last_update_submitted_qc>August 13, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">August 14, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Neurologic neglect syndrome</keyword>
  <keyword>post stroke</keyword>
  <keyword>transcranial direct current stimulation (tDCS)</keyword>
  <keyword>prismatic adaptation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Syndrome</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/NCT02213640
org study id: 2013-803
nct id: NCT02213640
lead sponsor: 
has dmc: No
Following stroke, over 50% of patients keep severe neurological deficiency whose unilateral
      neglect, mostly following a right hemispheric lesion. The prismatic adaptation involves to
      pointing movements toward visual targets wearing prismatic glasses. These prismatic glasses
      induce a shift to the right visual field for improving symptoms in short term.

      Transcranial direct stimulation (tDCS) has been evaluated for different types of deficiency
      resulting from stroke with encouraging results. The hypothesis of the study is to evaluate
      the usefulness of brain stimulation as an adjunctive intervention to optimize and increase
      the rehabilitation of unilateral neglect to long-term.

      Thus, the main objective is to evaluate the effectiveness of standard treatment with
      prismatic adaptation with anodal tDCS or sham tDCS.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Behavioural Inattention Test (BIT)
time frame: Change in BIT score between the baseline sessions average and score measured at week 11
description: assessed at two baseline sessions before intervention (inclusion and week 3), and after the therapeutic intervention week (week 5), 2 weeks (week 7), 6 weeks (week 11) and 15 weeks (week 20) following the inclusion.
measure: Negligence Battery Test (BTN)
time frame: before intervention (week 1 and week 3), and then again following the intervention (week 5), 2 weeks (week 7), 6 weeks (week 11) and 15 weeks (week 20)
description: Change in BTN scores between baseline measures before the therapeutic intervention week and scores obtained during each follow-up sessions
measure: Functional independence scale (MIF)
time frame: before intervention (week 1 and week 3), and then again following the intervention (week 5), 2 weeks (week 7), 6 weeks (week 11) and 15 weeks (week 20)
description: Change in MIF scores between baseline measures before the therapeutic intervention week and scores obtained during each follow-up sessions
measure: Catherine Bergego scale (ECB)
time frame: baseline session before intervention (week 1 and week 3), and then again following the intervention (week 5), 2 weeks (week 7), 6 weeks (week 11) and 15 weeks (week 20)
description: Change in ECB scores between baseline measures before the therapeutic intervention week and scores obtained during each follow-up sessions
measure: Jamar
time frame: baseline session before intervention (week 1 and week 3), and then again following the intervention (week 5), 2 weeks (week 7), 6 weeks (week 11) and 15 weeks (week 20)
description: Change in Jamar scores between baseline measures before the therapeutic intervention week and scores obtained during each follow-up sessions
arm group label: Arm A Anodal tDCS and prismatic adaptation
arm group type: Experimental
description: anodal tDCS over the primary motor cortex : stimulation intensity of 1mA during 20 minutes (5 consecutive sessions during one week).
arm group label: Arm B: control
arm group type: Placebo Comparator
description: Prismatic adaptation with placebo stimulation
intervention type: Device
intervention name: transcranial direct current stimulation (tDCS)
description: Anodal tDCS over the primary motor cortex. Stimulation intensity of 1mA during 20 minutes (5 consecutive sessions during one week).
arm group label: Arm A Anodal tDCS and prismatic adaptation
intervention type: Device
intervention name: Control: placebo stimulation
description: electrode of sham tDCS over the primary motor cortex during 20 minutes (5 consecutive sessions during one week).
arm group label: Arm B: control
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Sophie JACQUIN-COURTOIS, MD-PhD
role: Principal Investigator
affiliation: Hospices Civils de Lyon
facility: 
country: France
responsible party type: Sponsor
mesh term: Syndrome