<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/NCT04499092</url>
  </required_header>
  <id_info>
    <org_study_id>607rev1</org_study_id>
    <nct_id>NCT04499092</nct_id>
  </id_info>
  <brief_title>COgnitive REhabilitation in Pediatric Patients With sABI From Vegetative State to Functional Recovery</brief_title>
  <acronym>COREABI</acronym>
  <official_title>COgnitive REhabilitative Treatments in Pediatric Patients With Severe Acquired Brain Injury From Vegetative State to Functional Recovery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>IRCCS Eugenio Medea</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>IRCCS Eugenio Medea</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>
      Acquired brain lesions (GCLA) represent one of the most important cause of disability and&#xD;
      mortality during the pediatric age, also in the western Countries. The important medical&#xD;
      progresses of the last decade in the medical field have increased the percentages of&#xD;
      survival, also in the most severe clinical pictures. On the other hand, a brain lesion&#xD;
      reported in the first years of life presents with a more dramatic impact on the cognitive and&#xD;
      neurological development of the patients and it can significantly interfere with the same&#xD;
      quality of their life. Recent studies suggest that a brain damage in this stage of the life&#xD;
      is related to more persistent sequelae in comparison of the same lesion reported by an adult&#xD;
      patient, because of the neurological immaturity at the moment of the insult. Furthermore, in&#xD;
      most cases, the brain lesion is related not only to motor and sensorial deficits but also to&#xD;
      very important behavioral and cognitive problems, that can arise immediately after the acute&#xD;
      phase, or also several years after the pathological event.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The aims of the present study are:&#xD;
&#xD;
        1. To contribute to the adaptation of the Italian version of the Coma Recovery Scale&#xD;
           (CRS-R) for the pediatric age, with specific differentiation and taking into account the&#xD;
           age of the patients and the specific learning that characterize each developmental&#xD;
           stage;&#xD;
&#xD;
        2. As regards the patients with an adequate cognitive profile, to compare the effectiveness&#xD;
           of a traditional multifunction neuropsychological treatment (cognitive functions are&#xD;
           stimulated at the same time) vs a sequential treatment (cognitive functions are&#xD;
           stimulated step by step).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 1, 2019</start_date>
  <completion_date type="Actual">February 28, 2022</completion_date>
  <primary_completion_date type="Actual">February 28, 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>Validation of assessement scale; study of the effectivness of two models of neuropsychological intervention</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
    <masking_description>Caregivers of participants don't know what kind of treatment will be proposed.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Multifunction treatment (Attention)</measure>
    <time_frame>immediately after the intervention</time_frame>
    <description>Continuous Performance Test 2nd Edition (CPT, Conners, 2000): is a neuropsychological test that measures a person's sustained and selective attention. Sustained attention is the ability to maintain a consistent focus on some continuous activity or stimuli, and is associated with impulsivity. Selective attention is the ability to focus on relevant stimuli and ignore competing stimuli. This skill is associated with distractibility</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Multifunction treatment (Attention)</measure>
    <time_frame>immediately after the intervention</time_frame>
    <description>Developmental Age Neuropsychological Evaluation Battery (DANEB, Gugliotta et al. 2005) is a test battery for the neuropsychological evaluation of the main cognitive functions (language, visual perception, memory, neuro-motor associations, attention, higher executive functions, reading, writing and calculation) in children from 5 to 11 years old. It helps analyze the development of cognitive functions and the detection of developmental or acquired cognitive pathologies.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Multifunction treatment (Memory)</measure>
    <time_frame>immediately after intervention</time_frame>
    <description>Rey-Osterrieth complex figure test (ROCF, Rey, 1941) is a neuropsychological assessment in which examinees are asked to reproduce a complicated line drawing, first by copying it freehand (recognition), and then drawing from memory (recall).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Multifunction treatment (Memory)</measure>
    <time_frame>immediately after intervention</time_frame>
    <description>Corsi Test (De Renzi &amp; Nicheli, 1975) is a neuropsychological assessment that measures the visual spatial span, that is the quantity of visual and spatial information that it is possible to maintain in the Short-Term Memory</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Multifunction treatment (Memory)</measure>
    <time_frame>immediately after intervention</time_frame>
    <description>Digit Sequencing or Digit Span test (Blackburn, 1957) is one of the main tools developed to measure one's verbal working memory. The test was originally designed to test working memory and attention, as part of the Wechsler Intelligence Scale. Usually, the examiner reads a list of numbers, and the participant repeats them until an incorrect answer is given.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Multifunction treatment (Memory)</measure>
    <time_frame>immediately after intervention</time_frame>
    <description>Developmental Age Neuropsychological Evaluation Battery (DANEB, Gugliotta et al. 2005): see above</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Multifunction treatment (Executive Functions)</measure>
    <time_frame>immediately after intervention</time_frame>
    <description>Tower of London test (Shallice, 1982) is a test used in applied clinical neuropsychology for the assessment of executive functioning specifically to detect deficits in planning.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Multifunction treatment (Executive Functions)</measure>
    <time_frame>immediately after intervention</time_frame>
    <description>Wisconsin Card Sorting Test (WCST, Kongs, Thompson, Iverson, &amp; Heaton, 2000) is a neuropsychological test that is frequently used to measure such higher-level cognitive processes as attention, perseverance, WM, abstract thinking, and set shifting.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Multifunction treatment (Executive Functions)</measure>
    <time_frame>immediately after intervention</time_frame>
    <description>Behavior Rating Inventory of Executive Function (BRIEF; Gioia et al. 2000) is an assessment of executive function behaviors at home and at school for children and adolescents ages 5-18.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Multifunction treatment (Executive Functions)</measure>
    <time_frame>immediately after intervention</time_frame>
    <description>Developmental NEuroPSYchological Assessment (NEPSY, Korkman, Kirk &amp; Kemp, 1998) is a series of neuropsychological tests that are used in various combinations to assess neuropsychological development in children ages 3-16 years in six functional domains.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Multifunction treatment (Visual perceptual functions)</measure>
    <time_frame>immediately after intervention</time_frame>
    <description>Test of Visual Perceptual Skills (TVPS-4, Martin, 2008) is the latest update of the standard comprehensive assessment of visual analysis and processing skills. The TVPS-4 remains an easy-to-use assessment for determining visual-perceptual strengths and weaknesses.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Multifunction treatment (Visual perceptual functions)</measure>
    <time_frame>immediately after intervention</time_frame>
    <description>Benton Visual Retention Test (Benton test or BVRT, Benton, 1946) is an individually administered test for people aged from eight years to adulthood that measures visual perception and visual memory. It can also be used to help identify possible learning disabilities among other afflictions that might affect an individual's memory.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Multifunction treatment (Visual perceptual functions)</measure>
    <time_frame>immediately after intervention</time_frame>
    <description>Rey-Osterrieth complex figure test (ROCF, Rey, 1941): see above</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">80</enrollment>
  <condition>Acquired Brain Injury</condition>
  <condition>Development, Child</condition>
  <arm_group>
    <arm_group_label>Multifunction treatment</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients that will receive a simulataneous multifunction treatment</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sequential treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will receive a sequential function by function treatment</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Neuropsychological treatment</intervention_name>
    <description>Neuropsychological treatment</description>
    <arm_group_label>Multifunction treatment</arm_group_label>
    <arm_group_label>Sequential treatment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        For the adaptation of the CRS-R:&#xD;
&#xD;
        Healthy subjects:&#xD;
&#xD;
          -  children aged between 0 and 5 years (N=48);&#xD;
&#xD;
          -  normal development.&#xD;
&#xD;
        Clinical subjects:&#xD;
&#xD;
          -  Age between 0 and 10 at the moment of the pathological event;&#xD;
&#xD;
          -  LOCFAS score &lt;5;&#xD;
&#xD;
          -  A documented diagnosis of severe acquired brain lesion of traumatic, anoxic, vascular&#xD;
             or infective etiology (Glasgow Coma Scale, GCS&lt;12);&#xD;
&#xD;
          -  Brain lesion reported within one year from the day of the inclusion in the study.&#xD;
&#xD;
        For the comparison between multifunction treatment vs sequential treatment:&#xD;
&#xD;
          -  Age between 5 and 18 years at the moment of the pathological event;&#xD;
&#xD;
          -  LOCFAS score&gt;5&#xD;
&#xD;
          -  time between the GCLA and the assessment &lt; 3 months&#xD;
&#xD;
          -  Documented GCLA&#xD;
&#xD;
          -  GCS &lt;12 in the acute phase&#xD;
&#xD;
          -  Negative anamnesis for other developmental disorders before the GCLA&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>3 Months</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>IRCCS Eugenio Medea</name>
      <address>
        <city>Bosisio Parini</city>
        <zip>23842</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>February 25, 2020</study_first_submitted>
  <study_first_submitted_qc>July 30, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 5, 2020</study_first_posted>
  <last_update_submitted>March 1, 2023</last_update_submitted>
  <last_update_submitted_qc>March 1, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 2, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Rehabilitation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Brain Injuries</mesh_term>
    <mesh_term>Persistent Vegetative State</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/NCT04499092
org study id: 607rev1
nct id: NCT04499092
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Acquired brain lesions (GCLA) represent one of the most important cause of disability and
      mortality during the pediatric age, also in the western Countries. The important medical
      progresses of the last decade in the medical field have increased the percentages of
      survival, also in the most severe clinical pictures. On the other hand, a brain lesion
      reported in the first years of life presents with a more dramatic impact on the cognitive and
      neurological development of the patients and it can significantly interfere with the same
      quality of their life. Recent studies suggest that a brain damage in this stage of the life
      is related to more persistent sequelae in comparison of the same lesion reported by an adult
      patient, because of the neurological immaturity at the moment of the insult. Furthermore, in
      most cases, the brain lesion is related not only to motor and sensorial deficits but also to
      very important behavioral and cognitive problems, that can arise immediately after the acute
      phase, or also several years after the pathological event.
The aims of the present study are:

        1. To contribute to the adaptation of the Italian version of the Coma Recovery Scale
           (CRS-R) for the pediatric age, with specific differentiation and taking into account the
           age of the patients and the specific learning that characterize each developmental
           stage;

        2. As regards the patients with an adequate cognitive profile, to compare the effectiveness
           of a traditional multifunction neuropsychological treatment (cognitive functions are
           stimulated at the same time) vs a sequential treatment (cognitive functions are
           stimulated step by step).
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Validation of assessement scale; study of the effectivness of two models of neuropsychological intervention
primary purpose: Treatment
masking: Single (Participant)
masking description: Caregivers of participants don't know what kind of treatment will be proposed.
measure: Multifunction treatment (Attention)
time frame: immediately after the intervention
description: Continuous Performance Test 2nd Edition (CPT, Conners, 2000): is a neuropsychological test that measures a person's sustained and selective attention. Sustained attention is the ability to maintain a consistent focus on some continuous activity or stimuli, and is associated with impulsivity. Selective attention is the ability to focus on relevant stimuli and ignore competing stimuli. This skill is associated with distractibility
measure: Multifunction treatment (Attention)
time frame: immediately after the intervention
description: Developmental Age Neuropsychological Evaluation Battery (DANEB, Gugliotta et al. 2005) is a test battery for the neuropsychological evaluation of the main cognitive functions (language, visual perception, memory, neuro-motor associations, attention, higher executive functions, reading, writing and calculation) in children from 5 to 11 years old. It helps analyze the development of cognitive functions and the detection of developmental or acquired cognitive pathologies.
measure: Multifunction treatment (Memory)
time frame: immediately after intervention
description: Rey-Osterrieth complex figure test (ROCF, Rey, 1941) is a neuropsychological assessment in which examinees are asked to reproduce a complicated line drawing, first by copying it freehand (recognition), and then drawing from memory (recall).
measure: Multifunction treatment (Memory)
time frame: immediately after intervention
description: Corsi Test (De Renzi & Nicheli, 1975) is a neuropsychological assessment that measures the visual spatial span, that is the quantity of visual and spatial information that it is possible to maintain in the Short-Term Memory
measure: Multifunction treatment (Memory)
time frame: immediately after intervention
description: Digit Sequencing or Digit Span test (Blackburn, 1957) is one of the main tools developed to measure one's verbal working memory. The test was originally designed to test working memory and attention, as part of the Wechsler Intelligence Scale. Usually, the examiner reads a list of numbers, and the participant repeats them until an incorrect answer is given.
measure: Multifunction treatment (Memory)
time frame: immediately after intervention
description: Developmental Age Neuropsychological Evaluation Battery (DANEB, Gugliotta et al. 2005): see above
measure: Multifunction treatment (Executive Functions)
time frame: immediately after intervention
description: Tower of London test (Shallice, 1982) is a test used in applied clinical neuropsychology for the assessment of executive functioning specifically to detect deficits in planning.
measure: Multifunction treatment (Executive Functions)
time frame: immediately after intervention
description: Wisconsin Card Sorting Test (WCST, Kongs, Thompson, Iverson, & Heaton, 2000) is a neuropsychological test that is frequently used to measure such higher-level cognitive processes as attention, perseverance, WM, abstract thinking, and set shifting.
measure: Multifunction treatment (Executive Functions)
time frame: immediately after intervention
description: Behavior Rating Inventory of Executive Function (BRIEF; Gioia et al. 2000) is an assessment of executive function behaviors at home and at school for children and adolescents ages 5-18.
measure: Multifunction treatment (Executive Functions)
time frame: immediately after intervention
description: Developmental NEuroPSYchological Assessment (NEPSY, Korkman, Kirk & Kemp, 1998) is a series of neuropsychological tests that are used in various combinations to assess neuropsychological development in children ages 3-16 years in six functional domains.
measure: Multifunction treatment (Visual perceptual functions)
time frame: immediately after intervention
description: Test of Visual Perceptual Skills (TVPS-4, Martin, 2008) is the latest update of the standard comprehensive assessment of visual analysis and processing skills. The TVPS-4 remains an easy-to-use assessment for determining visual-perceptual strengths and weaknesses.
measure: Multifunction treatment (Visual perceptual functions)
time frame: immediately after intervention
description: Benton Visual Retention Test (Benton test or BVRT, Benton, 1946) is an individually administered test for people aged from eight years to adulthood that measures visual perception and visual memory. It can also be used to help identify possible learning disabilities among other afflictions that might affect an individual's memory.
measure: Multifunction treatment (Visual perceptual functions)
time frame: immediately after intervention
description: Rey-Osterrieth complex figure test (ROCF, Rey, 1941): see above
arm group label: Multifunction treatment
arm group type: Active Comparator
description: Patients that will receive a simulataneous multifunction treatment
arm group label: Sequential treatment
arm group type: Experimental
description: Patients will receive a sequential function by function treatment
intervention type: Behavioral
intervention name: Neuropsychological treatment
description: Neuropsychological treatment
arm group label: Multifunction treatment
arm group label: Sequential treatment
criteria: 
gender: All
minimum age: 3 Months
maximum age: 18 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Italy
responsible party type: Sponsor
mesh term: Brain Injuries
mesh term: Persistent Vegetative State
sharing ipd: No