COgnitive REhabilitation in Pediatric Patients with ABI, from Vegetative State to Functional Recovery (COREABI)

December 10, 2024 updated by: IRCCS Eugenio Medea

COgnitive REhabilitation Treatments in Pediatric Patients with Acquired Brain Injury. from Vegetative State to Functional Recovery.

Acquired brain injuries (ABI) represent one of the most important cause of disability and mortality during the pediatric age, also in the western Countries. The important medical progress of the last decade has increased the percentages of survivals, also in patients with the most severe clinical pictures. On the other hand, a brain injury reported in the first years of life presents with a more dramatic impact on cognitive and neurological development of patients and it may significantly interfere with adjustment, vocational perspectives and quality of life. Recent studies suggest that a brain damage at an early stage of development is related to more persistent sequelae in comparison with a comparable lesion reported by an adult patient, because of the neurological immaturity of the central nervous system at the moment of the insult. Furthermore, in most cases, a brain injury is related not only to motor and sensory deficits but also to significant behavioral and cognitive problems, that may occur immediately after the acute phase and persist or worsen over the years.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The aims of the present study are:

  1. To contribute to the adaptation of the Italian version of the Coma Recovery Scale for pediatrics, investigating behavioral responses of children across different age and developmental levels. Typically developing children and children with disorder of cosciousness due to ABI will be included;
  2. For patients with an adequate cognitive profile, to compare the efficacy of two multidomain neuropsychological interventions: a personalized neuropsychological treatment and a sequential neuropsychological treatment. In the personalized neuropsychological treatment each patient will receive greater stimulation of the most deficient cognitive function(s), while at the same time being trained on all the other functions; in the sequential neuropsychological treatment, a fixed-dose stimulation of each cognitive function following a sequential order will be provided.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
184

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Italy
      • Bosisio Parini, Italy, 23842
        • IRCCS Eugenio Medea

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

3 months to 18 years (Child)

Accepts Healthy Volunteers

Yes

Description

-For the adaptation/validation of the Coma Recovery Scale for pediatrics for the Italian context (typically developing children, healthy volunteers)

Inclusion Criteria:

  • children aged between 0 and 5 years
  • no suspicion of the presence of a neurodevelopmental disorder
  • For the preliminary validation of the Coma Recovery Scale in clinical subjects:

Inclusion criteria:

  • age between 0 and 10 years at the moment of the pathological event
  • LOCFAS score <5
  • a documented diagnosis of moderate-to-severe acquired brain injury of traumatic, anoxic, vascular or infective etiology (Glasgow Coma Scale, GCS<12)
  • a brain lesion reported within one year from study inclusion
  • For the evaluation and comparison of the efficacy of two multidomain neuropsychological treatments (CORE-ABI vs SET-ABI) in children emerged from a disorder of consciousness:
  • age between 5:0 and 17:11 years at the moment of the ABI
  • LOCFAS score>5
  • time between ABI and assessment <3 months
  • GCS <12 in the acute phase
  • negative anamnesis for other developmental disorders before the ABI

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Personalized neuropsychological treatment (CORE-ABI)
Each patient will receive greater stimulation of the most deficient cognitive function(s), while at the same time being trained on all the other functions.
Other: Personalized Neuropsychological treatment (CORE-ABI)
Personalized neuropsychological treatment. In the CORE-ABI intervention, the stimulation of cognitive functions will be provided based on a weekly evaluation of child's cognitive profile by a qualified neuropsychologist. Each session will have a duration of 45 min. While the first 30 minutes will be devoted to the stimulation of the most impaired cognitive function(s), the remaining 15 minutes will ensure the stimulation of the other cognitive subdomains. Domains addressed by the intervention will be the following: selective attention, sustained and divided attention, inhibition and shifting, visual-perceptual abilities, visual-spatial abilities, visual-constructional abilities, short-term memory, long-term memory, working-memory, categorization/reasoning/abstraction, problem-solving/planning and socio-emotional skills.
Experimental: Sequential neuropsychological treatment (SET-ABI)
Each patient will receive a fixed-dose stimulation of each cognitive function following a sequential order.
Other: Sequential Neuropsychological treatment (SET-ABI)

Sequential Neuropsychological Treatment. In the SET-ABI intervention, the stimulation of cognitive functions will be provided following a sequential order, identical for each child and for each session in each setting (neuropsychological treatment, speech therapy treatment and psychoeducational treatment). Each session will have a duration of 45 min.

Specifically, the first three weeks (weeks 1-3) of treatment will target attention; in weeks 4-6, the domain of visual-spatial and visual-constructional abilities will be addressed; in weeks 7-9, memory will be the target domain; in weeks 10-12, executive functions and socio-emotional skills will be addressed.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Conners Kiddie Continuous Performance Test-2nd Edition -K-CPT-2/Continuous Performance Test-3rd Edition -CPT-3
Time Frame: before and immediately after the intervention
Conners Kiddie Continuous Performance Test-2nd Edition -K-CPT-2/Continuous Performance Test-3rd Edition-CPT-3 measure sustained attention. K-CPT-2 is used with children aged up to 7:11 years, while CPT-3 is adopted with children aged 8:0-17:11 years. Scores will be expressed as T scores (M=50, SD=10). Higher scores indicate worse outcomes.
before and immediately after the intervention

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
BVN visual selective attention
Time Frame: before and immediately after the intervention
The visual selective attention task (BVN visual selective attention) of the Italian battery 'Batteria di valutazione neuropsicologica per l'età evolutiva -BVN 5-11' [Battery for neuropsychological evaluation for developmental age -BVN 5-11] will be used for children aged 5:0-11:11 years; the same task included in the Italian battery 'Batteria di Valutazione Neuropsicologica per l'adolescenza -BVN 12-18' [Battery of neuropsychological evaluation for adolescence -BVN 12-18] will be used for children aged 12:0-17:11 years. Scores will be expressed as z-scores (M=0; SD=1), with higher scores indicating better outcomes.
before and immediately after the intervention
Benton Judgment of Line Orientation Test
Time Frame: before and immediately after the intervention
The Benton Judgment of Line Orientation Test will be used to test visual-spatial orientation. The test targets subjects from 7:0 years onwards. Scores will be expressed as z-scores (M=0; SD=1), with higher scores indicating better outcomes.
before and immediately after the intervention
BVN Phonemic fluency
Time Frame: before and immediately after the intervention
The phonemic fluency task (BVN phonemic fluency) included in the Italian 'Batteria di valutazione neuropsicologica per l'età evolutiva 5-11' [Battery for neuropsychological evaluation for developmental age -BVN 5-11] will be used for children aged 5:0-11:11 and the one included in the Italian 'Batteria di Valutazione Neuropsicologica per l'adolescenza' [Battery of neuropsychological evaluation for adolescence-BVN 12-18] will be used for children aged 12:0-17:11 years. Scores will be expressed as z-scores. (M=0; SD=1), with higher scores indicating better outcomes.
before and immediately after the intervention
ToL Total moves
Time Frame: before and immediately after the intervention
The Tower of London (ToL) will be used to assess planning and related problem-solving abilities. Total moves score will be used to evaluate the accuracy of planning. Scores will be expressed as Standard scores (M=100; SD=15) with higher scores indicating better outcomes. The administration sheet and normative data are available for children aged 7:0-15:11 years and adolescents and adults aged 16:0 years or older; thus children of this study aged less than 7:0 years will be not administered this test.
before and immediately after the intervention
NEPSY-II Theory of Mind subscale
Time Frame: before and immediately after the intervention
The 'Theory of mind' subscale of the Italian version of the battery -A Developmental NEuroPSYchological Assessment-II (NEPSY-II) will be administered. The Theory of Mind subscale-part A assesses the understanding of mental functions and other people's perspectives, with raw scores ranging from 0 to 17; the Theory of Mind subscale-part B examines the ability to match basic emotions to specific situations. Scores will be expressed as scaled scores (M=10, SD=3), ranging from 1 to 19. Higher scores indicated better outcomes. As NEPSY-II was developed and validated for children aged 3:0-16:11 years, scores of adolescents aged 17:0-17:11 years will be calculated by considering norms for adolescents aged 15:0-16:11 years.
before and immediately after the intervention
BVN Immediate word list recall task
Time Frame: before and immediately after the intervention
The BVN immediate word list recall task will be used to assess short-term verbal memory. The task included in the Italian 'Batteria di valutazione neuropsicologica per l'età evolutiva -BVN 5-11-' [Battery for neuropsychological evaluation for developmental age -BVN 5-11] will be used for children aged 5:0-11:11 years, while the one included in the Italian 'Batteria di Valutazione Neuropsicologica per l'adolescenza -BVN 12-18' ['Battery for neuropsychological evaluation for adolescence -BVN 12-18] will be used for children aged 12:0-17:11 years. Scores will be expressed as z-scores (M=0; SD=1) with higher scores indicating better outcomes.
before and immediately after the intervention
MCST/WCST Errors
Time Frame: before and immediately after the intervention
Cognitive flexibility will be assessed by using the computerized Modified Card Sorting Test (MCST) and the computerized Wisconsin Card Sorting Test (WCST). The MCST will be used for children aged 5:0-7:11, while the WCST will be used for children aged 8:0-17:11. The number of total errors (MCST/WCST errors), which represents the sum of perseverative and non-perseverative errors, will be considered for this study. Scores will be expressed as Standard scores (M=100; SD=15), with higher scores indicating better outcomes.
before and immediately after the intervention
BVN Forward digit span
Time Frame: before and immediately after the intervention
The forward digit span test will be used to assess short-term memory. The task included in the Italian 'Batteria di valutazione neuropsicologica per l'età evolutiva -BVN 5-11' [Battery for neuropsychological evaluation for developmental age -BVN 5-11] will be used for children aged 5:0-11:11 years, while the one included in the Italian 'Batteria di Valutazione Neuropsicologica per l'adolescenza -BVN 12-18' ['Battery of neuropsychological evaluation for adolescence -BVN 12-18] will be used for children aged 12:0-17:11 years. Scores will be expressed as z-scores (M=0; SD=1) with higher scores indicating better outcomes.
before and immediately after the intervention
BVN Corsi
Time Frame: before and immediately after the intervention
The Corsi block tapping task (BVN Corsi) will be used to assess visual-spatial working-memory. The task included in the Italian 'Batteria di valutazione neuropsicologica per l'età evolutiva -BVN 5-11' [Battery for neuropsychological evaluation for developmental age -BVN 5-11] will be used for children aged 5:0-11:11; the same task included in the Italian 'Batteria di Valutazione Neuropsicologica per l'adolescenza -BVN 12-18' ['Battery of neuropsychological evaluation for adolescence -BVN 12-18] will be used for children aged 12:0-17:11 years. Scores will be expressed as z-scores (M=0; SD=1) with higher scores indicating better outcomes.
before and immediately after the intervention
Rey-Osterrieth Complex Figure Test-recall task (ROCF-recall)
Time Frame: before and immediately after the intervention
The Rey-Osterrieth Complex Figure Test-recall task (ROCF-recall) will be used to evaluate long-term visual-spatial memory. In this task children will be required to reproduce a complicated line drawing 30 minutes after presentation. Scores will be expressed as z scores (M=0; SD=1), with higher scores indicating better outcomes.
before and immediately after the intervention
Rey-Osterrieth Complex Figure Test -copy task (ROCF-copy)
Time Frame: before and immediately after the intervention
The Rey-Osterrieth Complex Figure Test -copy task (ROCF-copy) will be adopted to assess visual-constructional abilities. The test targets subjects from 4:0 years onwards. Scores will be expressed as z scores (M=0; SD=1), with higher scores indicating better outcomes.
before and immediately after the intervention
NEPSY-II Affect Recognition subscale
Time Frame: before and immediately after the intervention
The 'Affect recognition' subscale of the Italian version of the battery -A Developmental NEuroPSYchological Assessment-II (NEPSY-II) will be administered. This subscale assesses the ability to recognize emotions on facial expressions. Scores will be expressed as scaled scores (M=10, SD=3), ranging from 1 to 19. Higher scores indicate better outcomes. As NEPSY-II was developed and validated for children aged 3:0-16:11 years, scores of adolescents aged 17:0-17:11 years will be calculated by considering norms for adolescents aged 15:0-16:11 years.
before and immediately after the intervention
Test of Visual Perceptual Skills-3rd Edition -TVPS-3-
Time Frame: before and immediately after the intervention
The Italian version of the Test of Visual Perceptual Skills-3rd Edition -TVPS-3- will be used to assess visual information processing. The test targets subjects from 4:0 years through 18:11. Scores will be expressed as Standard scores (M=100; SD=15), with higher scores indicating better outcomes.
before and immediately after the intervention
ToL Initiation Time
Time Frame: before and immediately after the intervention
The Tower of London (ToL) will be used to assess planning and related problem-solving abilities. Total Initiation time score will be used to evaluate the time used to planning for problem-solving. Scores will be expressed as Standard scores (M=100; SD=15) with higher scores indicating better outcomes. The administration sheet and normative data are available for children aged 7:0-15:11 years and adolescents and adults aged 16:0 years or older; thus children of this study aged less than 7:0 years will be not administered this test.
before and immediately after the intervention
BVN Backward digit span
Time Frame: before and immediately after the intervention
The Backward digit span test will be used to assess verbal working-memory. The task included in the Italian 'Batteria di valutazione neuropsicologica per l'età evolutiva -BVN 5-11' [Battery for neuropsychological evaluation for developmental age -BVN 5-11] will be used for children aged 5:0-11:11 years, while the one included in the Italian 'Batteria di Valutazione Neuropsicologica per l'adolescenza -BVN 12-18' ['Battery of neuropsychological evaluation for adolescence -BVN 12-18] will be used for children aged 12:0-17:11 years. Patients will be required to repeat a sequence of numbers presented by the examiner in a reverse order. Scores will be expressed as z-scores (M=0; SD=1) with higher scores indicating better outcomes.
before and immediately after the intervention
BVN Delayed word list recall task
Time Frame: before and immediately after the intervention
The BVN delayed word list recall task will be used to assess long-term verbal memory. The task included in the Italian 'Batteria di valutazione neuropsicologica per l'età evolutiva -BVN 5-11-' [Battery for neuropsychological evaluation for developmental age -BVN 5-11] will be used for children aged 5:0-11:11 years, while the one included in the Italian 'Batteria di Valutazione Neuropsicologica per l'adolescenza -BVN 12-18' ['Battery for neuropsychological evaluation for adolescence -BVN 12-18] will be used for children aged 12:0-17:11 years. Scores will be expressed as z-scores (M=0; SD=1) with higher scores indicating better outcomes.
before and immediately after the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
IRCCS Eugenio Medea

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 28, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 25, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 30, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 5, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 13, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 10, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 607rev1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Acquired Brain Injury

Clinical Trials on Personalized Neuropsychological treatment (CORE-ABI)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings