COgnitive REhabilitation in Pediatric Patients With sABI From Vegetative State to Functional Recovery (COREABI)
Primary Purpose
Acquired Brain Injury, Development, Child
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Neuropsychological treatment
Sponsored by
About this trial
This is an interventional treatment trial for Acquired Brain Injury focused on measuring Rehabilitation
Eligibility Criteria
Inclusion Criteria:
For the adaptation of the CRS-R:
Healthy subjects:
- children aged between 0 and 5 years (N=48);
- normal development.
Clinical subjects:
- Age between 0 and 10 at the moment of the pathological event;
- LOCFAS score <5;
- A documented diagnosis of severe acquired brain lesion of traumatic, anoxic, vascular or infective etiology (Glasgow Coma Scale, GCS<12);
- Brain lesion reported within one year from the day of the inclusion in the study.
For the comparison between multifunction treatment vs sequential treatment:
- Age between 5 and 18 years at the moment of the pathological event;
- LOCFAS score>5
- time between the GCLA and the assessment < 3 months
- Documented GCLA
- GCS <12 in the acute phase
- Negative anamnesis for other developmental disorders before the GCLA
Sites / Locations
- IRCCS Eugenio Medea
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Multifunction treatment
Sequential treatment
Arm Description
Patients that will receive a simulataneous multifunction treatment
Patients will receive a sequential function by function treatment
Outcomes
Primary Outcome Measures
Multifunction treatment (Attention)
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
Multifunction treatment (Attention)
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.
Multifunction treatment (Memory)
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).
Multifunction treatment (Memory)
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
Multifunction treatment (Memory)
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.
Multifunction treatment (Memory)
Developmental Age Neuropsychological Evaluation Battery (DANEB, Gugliotta et al. 2005): see above
Multifunction treatment (Executive Functions)
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.
Multifunction treatment (Executive Functions)
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.
Multifunction treatment (Executive Functions)
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.
Multifunction treatment (Executive Functions)
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.
Multifunction treatment (Visual perceptual functions)
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.
Multifunction treatment (Visual perceptual functions)
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.
Multifunction treatment (Visual perceptual functions)
Rey-Osterrieth complex figure test (ROCF, Rey, 1941): see above
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04499092
Brief Title
COgnitive REhabilitation in Pediatric Patients With sABI From Vegetative State to Functional Recovery
Acronym
COREABI
Official Title
COgnitive REhabilitative Treatments in Pediatric Patients With Severe Acquired Brain Injury From Vegetative State to Functional Recovery
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
October 1, 2019 (Actual)
Primary Completion Date
February 28, 2022 (Actual)
Study Completion Date
February 28, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
IRCCS Eugenio Medea
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
The aims of the present study are:
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;
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acquired Brain Injury, Development, Child
Keywords
Rehabilitation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Validation of assessement scale; study of the effectivness of two models of neuropsychological intervention
Masking
Participant
Masking Description
Caregivers of participants don't know what kind of treatment will be proposed.
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Multifunction treatment
Arm Type
Active Comparator
Arm Description
Patients that will receive a simulataneous multifunction treatment
Arm Title
Sequential treatment
Arm Type
Experimental
Arm Description
Patients will receive a sequential function by function treatment
Intervention Type
Behavioral
Intervention Name(s)
Neuropsychological treatment
Intervention Description
Neuropsychological treatment
Primary Outcome Measure Information:
Title
Multifunction treatment (Attention)
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
Time Frame
immediately after the intervention
Title
Multifunction treatment (Attention)
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.
Time Frame
immediately after the intervention
Title
Multifunction treatment (Memory)
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).
Time Frame
immediately after intervention
Title
Multifunction treatment (Memory)
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
Time Frame
immediately after intervention
Title
Multifunction treatment (Memory)
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.
Time Frame
immediately after intervention
Title
Multifunction treatment (Memory)
Description
Developmental Age Neuropsychological Evaluation Battery (DANEB, Gugliotta et al. 2005): see above
Time Frame
immediately after intervention
Title
Multifunction treatment (Executive Functions)
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.
Time Frame
immediately after intervention
Title
Multifunction treatment (Executive Functions)
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.
Time Frame
immediately after intervention
Title
Multifunction treatment (Executive Functions)
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.
Time Frame
immediately after intervention
Title
Multifunction treatment (Executive Functions)
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.
Time Frame
immediately after intervention
Title
Multifunction treatment (Visual perceptual functions)
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.
Time Frame
immediately after intervention
Title
Multifunction treatment (Visual perceptual functions)
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.
Time Frame
immediately after intervention
Title
Multifunction treatment (Visual perceptual functions)
Description
Rey-Osterrieth complex figure test (ROCF, Rey, 1941): see above
Time Frame
immediately after intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Months
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
For the adaptation of the CRS-R:
Healthy subjects:
children aged between 0 and 5 years (N=48);
normal development.
Clinical subjects:
Age between 0 and 10 at the moment of the pathological event;
LOCFAS score <5;
A documented diagnosis of severe acquired brain lesion of traumatic, anoxic, vascular or infective etiology (Glasgow Coma Scale, GCS<12);
Brain lesion reported within one year from the day of the inclusion in the study.
For the comparison between multifunction treatment vs sequential treatment:
Age between 5 and 18 years at the moment of the pathological event;
LOCFAS score>5
time between the GCLA and the assessment < 3 months
Documented GCLA
GCS <12 in the acute phase
Negative anamnesis for other developmental disorders before the GCLA
Facility Information:
Facility Name
IRCCS Eugenio Medea
City
Bosisio Parini
ZIP/Postal Code
23842
Country
Italy
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
COgnitive REhabilitation in Pediatric Patients With sABI From Vegetative State to Functional Recovery
We'll reach out to this number within 24 hrs