COgnitive REhabilitation Treatments in Pediatric Patients with Acquired Brain Injury. from Vegetative State to Functional Recovery.
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Acquired Brain Injury
- Sponsor
- IRCCS Eugenio Medea
- Enrollment
- 184
- Locations
- 1
- Primary Endpoint
- Conners Kiddie Continuous Performance Test-2nd Edition -K-CPT-2/Continuous Performance Test-3rd Edition -CPT-3
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
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.
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.
Investigators
Eligibility Criteria
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
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- MCST/WCST Errors(before and immediately after the intervention)
- Rey-Osterrieth Complex Figure Test-recall task (ROCF-recall)(before and immediately after the intervention)
- BVN visual selective attention(before and immediately after the intervention)
- ToL Total moves(before and immediately after the intervention)
- BVN Immediate word list recall task(before and immediately after the intervention)
- Benton Judgment of Line Orientation Test(before and immediately after the intervention)
- BVN Phonemic fluency(before and immediately after the intervention)
- NEPSY-II Theory of Mind subscale(before and immediately after the intervention)
- BVN Forward digit span(before and immediately after the intervention)
- Rey-Osterrieth Complex Figure Test -copy task (ROCF-copy)(before and immediately after the intervention)
- Test of Visual Perceptual Skills-3rd Edition -TVPS-3-(before and immediately after the intervention)
- BVN Delayed word list recall task(before and immediately after the intervention)
- BVN Corsi(before and immediately after the intervention)
- NEPSY-II Affect Recognition subscale(before and immediately after the intervention)
- ToL Initiation Time(before and immediately after the intervention)
- BVN Backward digit span(before and immediately after the intervention)