<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/NCT01730560</url>
  </required_header>
  <id_info>
    <org_study_id>2010.615</org_study_id>
    <secondary_id>2010-A00702-37</secondary_id>
    <nct_id>NCT01730560</nct_id>
  </id_info>
  <brief_title>Rehabilitation For Acquired Visual Field Defects: Development Of A Bottom-Up Approach</brief_title>
  <acronym>VISIOTRAIN</acronym>
  <official_title>Rehabilitation For Acquired Visual Field Defects: Development Of A Bottom-Up Approach</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>
      Cortical Visual Field Defects (CFVD) are common after acquired brain injury. They often cause&#xD;
      problems with reading and visual exploration which impact on patients' quality of life. Apart&#xD;
      from the substitutive method that uses prisms directly placed on glasses, two main&#xD;
      rehabilitative methods have been explored previously: one restorative and one compensatory.&#xD;
      The most effective methods seem to be based on compensatory training paradigms that target&#xD;
      eye movements. They rely on voluntary mass-practice that induces changes in exploratory&#xD;
      saccadic behaviour, particularly into the blind hemifield. Previous studies using this method&#xD;
      have shown changes in visual scanning patterns but with only a marginal profit in terms of&#xD;
      functional benefit.&#xD;
&#xD;
      In the present study, the investigators developed a new approach to the compensatory visual&#xD;
      field training based solely on a bottom-up mechanism. It does not require the patients'&#xD;
      ability to voluntarily maintain attention oriented to the affected field, which may be&#xD;
      difficult for brain-damaged patients. As previously reported in other pathological contexts&#xD;
      (e.g. use of prism adaptation or sensory stimulation in neglect patients), bypassing&#xD;
      voluntary and conscious implication of the patient can produce improvements by a more&#xD;
      automatic process.&#xD;
&#xD;
      The investigators hypotheses are: 1) that a novel ramp-step search paradigm can be used by&#xD;
      hemianopic patients to automatically improve targeted eye movements into their blind visual&#xD;
      field; and 2) that this will lead to behavioural improvements on ecologically valid tests of&#xD;
      visual search.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 29, 2010</start_date>
  <completion_date type="Actual">June 13, 2018</completion_date>
  <primary_completion_date type="Actual">June 13, 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>Crossover Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Difference in performance (mean reaction time - RT) of an ecological visual search task between pre-tests and immediate post-test for each patient according to treatment (A or B).</measure>
    <time_frame>1 week</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Errors and omissions at each evaluation session for the visual search task</measure>
    <time_frame>1, 2 and 5 weeks</time_frame>
    <description>Mean RT difference, errors and omissions at several visual tasks (rapid scanning task, exploratory visual tasks, reading task) at each evaluation session Parameters of visual field perimetry before and after treatment Oculo-motor parameters during the different tasks (i.e. amplitude and latencies for saccades and fixations)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">22</enrollment>
  <condition>Acquired Visual Field Defects</condition>
  <arm_group>
    <arm_group_label>Arm 1:Treatment A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Treatment A (active) followed by treatment B (neutral)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm 2: Treatment B</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Treatment B (neutral) followed by treatment A (active)</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Treatment A</intervention_name>
    <description>The computer-based training task consists of a novel ramp-step search paradigm with a stimulus traversing the screen from left to right or right to left. Subjects are asked to pursue the stimulus (ramp phase) and then saccade to find its location when it suddenly jumps (step phase). The stimulus is an open spinning circle. At the end of each movement, the gap can be located at the top or at the bottom, and patients are asked to indicate this location by pushing the response button as quickly as possible.&#xD;
The starting point will alternate between left and right. The training task includes 3 sessions with 100 movements each. Reaction Times and errors will be monitored online to ensure that the patient performs the task correctly.&#xD;
Each treatment phase has the same pattern:&#xD;
two visits in pre-tests evaluation (V1 and V2),&#xD;
one visit to perform treatment (A or B) and to assess immediate and 2h post-effects (V3),&#xD;
two visits after treatment (V4 at one week and V5 at one month).</description>
    <arm_group_label>Arm 1:Treatment A</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Treatment B</intervention_name>
    <description>Placebo treatment using the same computer-based training task, but including only the ramp phase.&#xD;
Each treatment phase has the same pattern:&#xD;
two visits in pre-tests evaluation (V1 and V2),&#xD;
one visit to perform treatment (A or B) and to assess immediate and 2h post-effects (V3),&#xD;
two visits after treatment (V4 at one week and V5 at one month).</description>
    <arm_group_label>Arm 2: Treatment B</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male/Female&#xD;
&#xD;
          -  Stroke (ischemia or hemorrhage) documented by CTscan or MRI&#xD;
&#xD;
          -  Traumatic brain injury (TBI) documented by CTscan or MRI&#xD;
&#xD;
          -  Right or Left hemianopia defined by perimetry&#xD;
&#xD;
          -  All subjects must be between the ages of 18-80&#xD;
&#xD;
          -  Aetiology of visual field defect : Stroke (ischemia or hemorrhage)&#xD;
&#xD;
          -  Delay post-stroke : at least 6 months&#xD;
&#xD;
          -  Only one lesion on CTscan or MRI (performed in a maximal delay of 6 months)&#xD;
&#xD;
          -  Corrected monocular visual acuity &gt; 5/10&#xD;
&#xD;
          -  Possible understanding of experimental conditions&#xD;
&#xD;
          -  Patient being able to be quiet and sit during at least 2 hours&#xD;
&#xD;
          -  Having given written informed consent prior to any procedure related to the study&#xD;
&#xD;
          -  Availability for the period of the study&#xD;
&#xD;
          -  Covered by a Health System where applicable, and/or in compliance with the&#xD;
             recommendations of the national laws in force relating to biomedical research&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Ophthalmologic criteria : monocular visual acuity &lt; 4/10, strabismus , diplopia ,&#xD;
             ocular instability , nystagmus, maculopathy , glaucoma , retinopathy , orthoptic&#xD;
             rehabilitation&#xD;
&#xD;
          -  Neurologic criteria : sever phasic disturbances , neurologic degenerative affection ,&#xD;
             non controlled seizure , severe handicap non compatible with prolonged sit position or&#xD;
             concentration during 30 consecutive minutes&#xD;
&#xD;
          -  No command of french language&#xD;
&#xD;
          -  Non stabilized medical situation&#xD;
&#xD;
          -  Females who are pregnant, nursing, or planning a pregnancy during the study period, or&#xD;
             females of childbearing potential, not using a reliable means of contraception.&#xD;
&#xD;
          -  Not under any administrative or legal supervision&#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>Service de Médecine Physique et de Réadaptation</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Service de Médecine Physique et de Réadaptation,Hôpital Henry Gabrielle</name>
      <address>
        <city>Saint Genis Laval</city>
        <zip>69235</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>July 2018</verification_date>
  <study_first_submitted>November 15, 2012</study_first_submitted>
  <study_first_submitted_qc>November 20, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 21, 2012</study_first_posted>
  <last_update_submitted>July 25, 2018</last_update_submitted>
  <last_update_submitted_qc>July 25, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">July 26, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT01730560
org study id: 2010.615
secondary id: 2010-A00702-37
nct id: NCT01730560
lead sponsor: 
has dmc: No
Cortical Visual Field Defects (CFVD) are common after acquired brain injury. They often cause
      problems with reading and visual exploration which impact on patients' quality of life. Apart
      from the substitutive method that uses prisms directly placed on glasses, two main
      rehabilitative methods have been explored previously: one restorative and one compensatory.
      The most effective methods seem to be based on compensatory training paradigms that target
      eye movements. They rely on voluntary mass-practice that induces changes in exploratory
      saccadic behaviour, particularly into the blind hemifield. Previous studies using this method
      have shown changes in visual scanning patterns but with only a marginal profit in terms of
      functional benefit.

      In the present study, the investigators developed a new approach to the compensatory visual
      field training based solely on a bottom-up mechanism. It does not require the patients'
      ability to voluntarily maintain attention oriented to the affected field, which may be
      difficult for brain-damaged patients. As previously reported in other pathological contexts
      (e.g. use of prism adaptation or sensory stimulation in neglect patients), bypassing
      voluntary and conscious implication of the patient can produce improvements by a more
      automatic process.

      The investigators hypotheses are: 1) that a novel ramp-step search paradigm can be used by
      hemianopic patients to automatically improve targeted eye movements into their blind visual
      field; and 2) that this will lead to behavioural improvements on ecologically valid tests of
      visual search.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Other
masking: Single (Participant)
measure: Difference in performance (mean reaction time - RT) of an ecological visual search task between pre-tests and immediate post-test for each patient according to treatment (A or B).
time frame: 1 week
measure: Errors and omissions at each evaluation session for the visual search task
time frame: 1, 2 and 5 weeks
description: Mean RT difference, errors and omissions at several visual tasks (rapid scanning task, exploratory visual tasks, reading task) at each evaluation session Parameters of visual field perimetry before and after treatment Oculo-motor parameters during the different tasks (i.e. amplitude and latencies for saccades and fixations)
arm group label: Arm 1:Treatment A
arm group type: Experimental
description: Treatment A (active) followed by treatment B (neutral)
arm group label: Arm 2: Treatment B
arm group type: Experimental
description: Treatment B (neutral) followed by treatment A (active)
intervention type: Other
intervention name: Treatment A
description: The computer-based training task consists of a novel ramp-step search paradigm with a stimulus traversing the screen from left to right or right to left. Subjects are asked to pursue the stimulus (ramp phase) and then saccade to find its location when it suddenly jumps (step phase). The stimulus is an open spinning circle. At the end of each movement, the gap can be located at the top or at the bottom, and patients are asked to indicate this location by pushing the response button as quickly as possible.
The starting point will alternate between left and right. The training task includes 3 sessions with 100 movements each. Reaction Times and errors will be monitored online to ensure that the patient performs the task correctly.
Each treatment phase has the same pattern:
two visits in pre-tests evaluation (V1 and V2),
one visit to perform treatment (A or B) and to assess immediate and 2h post-effects (V3),
two visits after treatment (V4 at one week and V5 at one month).
arm group label: Arm 1:Treatment A
intervention type: Other
intervention name: Treatment B
description: Placebo treatment using the same computer-based training task, but including only the ramp phase.
Each treatment phase has the same pattern:
two visits in pre-tests evaluation (V1 and V2),
one visit to perform treatment (A or B) and to assess immediate and 2h post-effects (V3),
two visits after treatment (V4 at one week and V5 at one month).
arm group label: Arm 2: Treatment B
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: Service de Médecine Physique et de Réadaptation
facility: 
country: France
responsible party type: Sponsor