<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/NCT03815266</url>
  </required_header>
  <id_info>
    <org_study_id>1708098</org_study_id>
    <secondary_id>2018-A01883-52</secondary_id>
    <nct_id>NCT03815266</nct_id>
  </id_info>
  <brief_title>Feasibility Study to Evaluate the Observance Rehabilitation of Upper Limbs by Visual-motor Simulation Associated at Transcranial Direct Current Stimulation (tDCS) in Hemiparetic Patient Post-stroke</brief_title>
  <acronym>SIMSTIM</acronym>
  <official_title>Feasibility Study to Evaluate the Observance Rehabilitation of Upper Limbs by Visual-motor Simulation Associated at Transcranial Direct Current Stimulation (tDCS) in Hemiparetic Patient Post-stroke.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Universitaire de Saint Etienne</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Hospitalier Universitaire de Saint Etienne</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>
      Although the mirror therapy is recognized as effective, its practice is difficult, especially&#xD;
      with hemiplegic patients. It is difficult for them to understand, control the movements and&#xD;
      carry out a double task with the two upper limbs. The implementation of a Computerized Mirror&#xD;
      Therapy (CMT) with the Intensive Visual Simulation 3 (IVS3) device makes it possible to limit&#xD;
      these problems by proposing pre-recorded sessions, not limited to the right or left&#xD;
      hemi-space, and proposing a work on proximal motricity. Since the functional prognosis of the&#xD;
      upper hemiplegic limb remains mostly unfavourable, a wide range of interventions should be&#xD;
      proposed. There is currently a consensus to consider the use of transcranial Direct Current&#xD;
      Stimulation (tDCS) stimulation in functional recovery after stroke as a method to enhance the&#xD;
      effectiveness of training techniques. Although all motor therapies can theoretically benefit&#xD;
      from increased effectiveness by the addition of transcranial Direct Current Stimulation&#xD;
      (tDCS), Computerized Mirror Therapy (CMT) has a high potential for sensitivity to&#xD;
      transcranial Direct Current Stimulation (tDCS) due to the intensity of the motor training of&#xD;
      the upper limb applied.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The primary objective of this study is to investigate the feasibility of a program combining&#xD;
      Computerized Mirror Therapy (CMT) with dual- transcranial Direct Current Stimulation (tDCS)&#xD;
      stimulation by evaluating observance to hemiparetic stroke patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    The study was stopped due to lack of inclusions&#xD;
  </why_stopped>
  <start_date type="Actual">September 20, 2018</start_date>
  <completion_date type="Actual">April 14, 2022</completion_date>
  <primary_completion_date type="Actual">March 7, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Rate of observance of the program Computerized Mirror Therapy (CMT) + transcranial Direct Current Stimulation (tDCS)</measure>
    <time_frame>Up to Day 40</time_frame>
    <description>Rate of observance of the program CMT + tDCS. It is will be measured by the number of patients who will be finished the study.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Effect of the program Computerized Mirror Therapy (CMT) + transcranial Direct Current Stimulation (tDCS) improving activities of the upper limb - measured by Frenchay arm test</measure>
    <time_frame>Day 40</time_frame>
    <description>To evaluate the effect of the program Computerized Mirror Therapy (CMT) + transcranial Direct Current Stimulation (tDCS) improving activities of the upper limb.&#xD;
It is will be measured by Frenchay arm test.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Effect of the program Computerized Mirror Therapy (CMT) + transcranial Direct Current Stimulation (tDCS) improving activities of the upper limb - measured by Frenchay arm test</measure>
    <time_frame>Day 70</time_frame>
    <description>To evaluate the effect of the program Computerized Mirror Therapy (CMT) + transcranial Direct Current Stimulation (tDCS) improving activities of the upper limb.&#xD;
It is will be measured by Frenchay arm test.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>occurrence of epileptic seizure</measure>
    <time_frame>Day 40</time_frame>
    <description>Measure of tolerance of the program Intensive Visual Simulation 3 (IVS3) + transcranial Direct Current Stimulation (tDCS) by the occurrence of epileptic seizure report by adverse event and serious adverse events.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>occurrence of Anxiety crisis</measure>
    <time_frame>Day 40</time_frame>
    <description>Measure of tolerance of the program Intensive Visual Simulation 3 (IVS3) + transcranial Direct Current Stimulation (tDCS) by the occurrence of anxiety crisis report by adverse event and serious adverse events.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tolerance Assessment Questionnaire</measure>
    <time_frame>Up to day 70</time_frame>
    <description>Analysis the results of the Tolerance Assessment Questionnaire.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of the program by Goal Attainment Scaling (GAS)</measure>
    <time_frame>Day 40</time_frame>
    <description>Analysis of evaluation of the program by Goal Attainment Scaling (GAS) results.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of the program by Goal Attainment Scaling (GAS)</measure>
    <time_frame>Day 70</time_frame>
    <description>Analysis of evaluation of the program by Goal Attainment Scaling (GAS) results.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quantitative improvement of the deficiencies - Fugl-Meyer test</measure>
    <time_frame>Day 40</time_frame>
    <description>Measure of the quantitative improvement of the deficiencies by analysis of Fugl-Meyer test results.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quantitative improvement of the deficiencies - Fugl-Meyer test</measure>
    <time_frame>Day 70</time_frame>
    <description>Measure of the quantitative improvement of the deficiencies by analysis of Fugl-Meyer test results.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Abilities to perform several activities - Abilhand questionnaire</measure>
    <time_frame>Day 40</time_frame>
    <description>Analysis of abilities to perform several activities in the daily life by Abilhand questionnaire results.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Abilities to perform several activities - Abilhand questionnaire</measure>
    <time_frame>Day 70</time_frame>
    <description>Analysis of abilities to perform several activities in the daily life by Abilhand questionnaire results.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">9</enrollment>
  <condition>Stroke</condition>
  <arm_group>
    <arm_group_label>Patient with first ischemic or hemorrhagic stroke</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patient with first ischemic or hemorrhagic stroke will be included. They will have the following program Computerized Mirror Therapy (CMT) associated at transcranial Direct Current Stimulation (tDCS). This program will consist of 5 sessions per week for 4 weeks (20 minutes).&#xD;
In more, they will have the following tests: Tolerance Assessment Questionnaire, Ashworth's scale, Frenchay arm test, Abilhand questionnaire, Fugl-Meyer test, and Goal Attainment Scaling (GAS).</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>transcranial Direct Current Stimulation (tDCS)</intervention_name>
    <description>transcranial Direct Current Stimulation (tDCS) is device which consist in setting up an electrode on the skull of the patient to deliver the low intensity current.&#xD;
Patient will have transcranial Direct Current Stimulation (tDCS) at each session and at the same time of Computerized Mirror Therapy (CMT).</description>
    <arm_group_label>Patient with first ischemic or hemorrhagic stroke</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Computerized Mirror Therapy (CMT)</intervention_name>
    <description>Computerized Mirror Therapy (CMT) will be realizing by the device Intensive Visual Simulation 3 (IVS3). Patient will have Computerized Mirror Therapy (CMT) at each session and at the same time of transcranial Direct Current Stimulation (tDCS).</description>
    <arm_group_label>Patient with first ischemic or hemorrhagic stroke</arm_group_label>
    <other_name>Intensive Visual Simulation3 (IVS3)</other_name>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Tolerance Assessment Questionnaire</intervention_name>
    <description>The Tolerance Assessment Questionnaire will be completed at the end of each session.</description>
    <arm_group_label>Patient with first ischemic or hemorrhagic stroke</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Ashworth's scale</intervention_name>
    <description>Ashworth's scale evaluates the resistance to stretching. This test will be completed before the start of the program, at the end of the program and one month after.</description>
    <arm_group_label>Patient with first ischemic or hemorrhagic stroke</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Frenchay arm test</intervention_name>
    <description>Frenchay arm test evaluates your abilities with the affected hand to perform several actions.&#xD;
This test will be completed before the start of the program, at the end of the program and one month after.</description>
    <arm_group_label>Patient with first ischemic or hemorrhagic stroke</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Abilhand questionnaire</intervention_name>
    <description>Abilhand questionnaire evaluates your abilities to perform several activities in the daily life with your arm affected.&#xD;
This test will be completed before the start of the program, at the end of the program and one month after.</description>
    <arm_group_label>Patient with first ischemic or hemorrhagic stroke</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Fugl-Meyer test</intervention_name>
    <description>Fugl-Meyer test evaluates your ability to perform different movements with all the joints of your arm affected.&#xD;
This test will be completed before the start of the program, at the end of the program and one month after.</description>
    <arm_group_label>Patient with first ischemic or hemorrhagic stroke</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Goal Attainment Scaling (GAS)</intervention_name>
    <description>Goal Attainment Scaling (GAS) sets therapeutic goals with the patient before the start of the program.&#xD;
These goals will be checked at the end of the program and one month after.</description>
    <arm_group_label>Patient with first ischemic or hemorrhagic stroke</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient with first ischemic or hemorrhagic stroke for less than one year, having not&#xD;
             recidivated since then and responsible for initially complete left or right hemiplegia&#xD;
&#xD;
          -  Modified Frenchay arm test score &lt;70 (/ 100)&#xD;
&#xD;
          -  Without a neurological history other than stroke&#xD;
&#xD;
          -  Having signed the written consent and affiliated or entitled to a social security&#xD;
             scheme&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient with contraindications to transcranial Direct Current Stimulation (tDCS) or&#xD;
             Transcranial Magnetic Stimulation (TMS) (brain metal implant, pacemaker, other&#xD;
             implanted active medical device)&#xD;
&#xD;
          -  Patient who didn't have cerebral Magnetic Resonance Imaging (MRI) imaging during their&#xD;
             stroke&#xD;
&#xD;
          -  With complete lesion of the primary motor cortex&#xD;
&#xD;
          -  With alcohol / drug dependence&#xD;
&#xD;
          -  With psychiatric illness, cognitive impairment, uncontrolled disease / epilepsy,&#xD;
             malignant disease, severe renal or pulmonary disease&#xD;
&#xD;
          -  With a history of disabling associated disease&#xD;
&#xD;
          -  With cerebellar syndrome&#xD;
&#xD;
          -  Pregnancy&#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>Pascal GIRAUX, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>CHU SAINT-ETIENNE</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Chu Saint-Etienne</name>
      <address>
        <city>Saint-Étienne</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>November 6, 2018</study_first_submitted>
  <study_first_submitted_qc>January 23, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 24, 2019</study_first_posted>
  <last_update_submitted>April 25, 2023</last_update_submitted>
  <last_update_submitted_qc>April 25, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 27, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>transcranial Direct Current Stimulation (tDCS)</keyword>
  <keyword>Computerized Mirror Therapy (CMT)</keyword>
  <keyword>hemiparetic</keyword>
  <keyword>Ischemic</keyword>
  <keyword>stroke</keyword>
  <keyword>Intensive Visual Simulation3 (IVS3)</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>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/NCT03815266
org study id: 1708098
secondary id: 2018-A01883-52
nct id: NCT03815266
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Although the mirror therapy is recognized as effective, its practice is difficult, especially
      with hemiplegic patients. It is difficult for them to understand, control the movements and
      carry out a double task with the two upper limbs. The implementation of a Computerized Mirror
      Therapy (CMT) with the Intensive Visual Simulation 3 (IVS3) device makes it possible to limit
      these problems by proposing pre-recorded sessions, not limited to the right or left
      hemi-space, and proposing a work on proximal motricity. Since the functional prognosis of the
      upper hemiplegic limb remains mostly unfavourable, a wide range of interventions should be
      proposed. There is currently a consensus to consider the use of transcranial Direct Current
      Stimulation (tDCS) stimulation in functional recovery after stroke as a method to enhance the
      effectiveness of training techniques. Although all motor therapies can theoretically benefit
      from increased effectiveness by the addition of transcranial Direct Current Stimulation
      (tDCS), Computerized Mirror Therapy (CMT) has a high potential for sensitivity to
      transcranial Direct Current Stimulation (tDCS) due to the intensity of the motor training of
      the upper limb applied.
The primary objective of this study is to investigate the feasibility of a program combining
      Computerized Mirror Therapy (CMT) with dual- transcranial Direct Current Stimulation (tDCS)
      stimulation by evaluating observance to hemiparetic stroke patients.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Rate of observance of the program Computerized Mirror Therapy (CMT) + transcranial Direct Current Stimulation (tDCS)
time frame: Up to Day 40
description: Rate of observance of the program CMT + tDCS. It is will be measured by the number of patients who will be finished the study.
measure: Effect of the program Computerized Mirror Therapy (CMT) + transcranial Direct Current Stimulation (tDCS) improving activities of the upper limb - measured by Frenchay arm test
time frame: Day 40
description: To evaluate the effect of the program Computerized Mirror Therapy (CMT) + transcranial Direct Current Stimulation (tDCS) improving activities of the upper limb.
It is will be measured by Frenchay arm test.
measure: Effect of the program Computerized Mirror Therapy (CMT) + transcranial Direct Current Stimulation (tDCS) improving activities of the upper limb - measured by Frenchay arm test
time frame: Day 70
description: To evaluate the effect of the program Computerized Mirror Therapy (CMT) + transcranial Direct Current Stimulation (tDCS) improving activities of the upper limb.
It is will be measured by Frenchay arm test.
measure: occurrence of epileptic seizure
time frame: Day 40
description: Measure of tolerance of the program Intensive Visual Simulation 3 (IVS3) + transcranial Direct Current Stimulation (tDCS) by the occurrence of epileptic seizure report by adverse event and serious adverse events.
measure: occurrence of Anxiety crisis
time frame: Day 40
description: Measure of tolerance of the program Intensive Visual Simulation 3 (IVS3) + transcranial Direct Current Stimulation (tDCS) by the occurrence of anxiety crisis report by adverse event and serious adverse events.
measure: Tolerance Assessment Questionnaire
time frame: Up to day 70
description: Analysis the results of the Tolerance Assessment Questionnaire.
measure: Evaluation of the program by Goal Attainment Scaling (GAS)
time frame: Day 40
description: Analysis of evaluation of the program by Goal Attainment Scaling (GAS) results.
measure: Evaluation of the program by Goal Attainment Scaling (GAS)
time frame: Day 70
description: Analysis of evaluation of the program by Goal Attainment Scaling (GAS) results.
measure: Quantitative improvement of the deficiencies - Fugl-Meyer test
time frame: Day 40
description: Measure of the quantitative improvement of the deficiencies by analysis of Fugl-Meyer test results.
measure: Quantitative improvement of the deficiencies - Fugl-Meyer test
time frame: Day 70
description: Measure of the quantitative improvement of the deficiencies by analysis of Fugl-Meyer test results.
measure: Abilities to perform several activities - Abilhand questionnaire
time frame: Day 40
description: Analysis of abilities to perform several activities in the daily life by Abilhand questionnaire results.
measure: Abilities to perform several activities - Abilhand questionnaire
time frame: Day 70
description: Analysis of abilities to perform several activities in the daily life by Abilhand questionnaire results.
arm group label: Patient with first ischemic or hemorrhagic stroke
arm group type: Experimental
description: Patient with first ischemic or hemorrhagic stroke will be included. They will have the following program Computerized Mirror Therapy (CMT) associated at transcranial Direct Current Stimulation (tDCS). This program will consist of 5 sessions per week for 4 weeks (20 minutes).
In more, they will have the following tests: Tolerance Assessment Questionnaire, Ashworth's scale, Frenchay arm test, Abilhand questionnaire, Fugl-Meyer test, and Goal Attainment Scaling (GAS).
intervention type: Diagnostic Test
intervention name: transcranial Direct Current Stimulation (tDCS)
description: transcranial Direct Current Stimulation (tDCS) is device which consist in setting up an electrode on the skull of the patient to deliver the low intensity current.
Patient will have transcranial Direct Current Stimulation (tDCS) at each session and at the same time of Computerized Mirror Therapy (CMT).
arm group label: Patient with first ischemic or hemorrhagic stroke
intervention type: Diagnostic Test
intervention name: Computerized Mirror Therapy (CMT)
description: Computerized Mirror Therapy (CMT) will be realizing by the device Intensive Visual Simulation 3 (IVS3). Patient will have Computerized Mirror Therapy (CMT) at each session and at the same time of transcranial Direct Current Stimulation (tDCS).
arm group label: Patient with first ischemic or hemorrhagic stroke
other name: Intensive Visual Simulation3 (IVS3)
intervention type: Diagnostic Test
intervention name: Tolerance Assessment Questionnaire
description: The Tolerance Assessment Questionnaire will be completed at the end of each session.
arm group label: Patient with first ischemic or hemorrhagic stroke
intervention type: Diagnostic Test
intervention name: Ashworth's scale
description: Ashworth's scale evaluates the resistance to stretching. This test will be completed before the start of the program, at the end of the program and one month after.
arm group label: Patient with first ischemic or hemorrhagic stroke
intervention type: Diagnostic Test
intervention name: Frenchay arm test
description: Frenchay arm test evaluates your abilities with the affected hand to perform several actions.
This test will be completed before the start of the program, at the end of the program and one month after.
arm group label: Patient with first ischemic or hemorrhagic stroke
intervention type: Diagnostic Test
intervention name: Abilhand questionnaire
description: Abilhand questionnaire evaluates your abilities to perform several activities in the daily life with your arm affected.
This test will be completed before the start of the program, at the end of the program and one month after.
arm group label: Patient with first ischemic or hemorrhagic stroke
intervention type: Diagnostic Test
intervention name: Fugl-Meyer test
description: Fugl-Meyer test evaluates your ability to perform different movements with all the joints of your arm affected.
This test will be completed before the start of the program, at the end of the program and one month after.
arm group label: Patient with first ischemic or hemorrhagic stroke
intervention type: Diagnostic Test
intervention name: Goal Attainment Scaling (GAS)
description: Goal Attainment Scaling (GAS) sets therapeutic goals with the patient before the start of the program.
These goals will be checked at the end of the program and one month after.
arm group label: Patient with first ischemic or hemorrhagic stroke
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Pascal GIRAUX, PhD
role: Principal Investigator
affiliation: CHU SAINT-ETIENNE
facility: 
country: France
responsible party type: Sponsor
mesh term: Stroke
sharing ipd: No