Clinical trial NCT04499092: COgnitive REhabilitation in Pediatric Patients with ABI, from Vegetative State to Functional Recovery
Official title: COgnitive REhabilitation Treatments in Pediatric Patients with Acquired Brain Injury. from Vegetative State to Functional Recovery.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acquired Brain Injury
Development, Child
Keywords: Rehabilitation
Lead sponsor: IRCCS Eugenio Medea
Sponsor class: OTHER
First posted: 2020-08-05
Enrollment: 184
Sex: ALL
Minimum age (years): 3
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study will have the following steps:

* Adaptation/preliminary validation of the CRS-R for the Italian context (typically developing children, healthy volunteers) (N=64)
* Preliminary validation of the CRS-R in a sample of Italian patients with disorder of consciousness (N=80)
* Evaluation and comparison of the efficacy of two multidomain neuropsychological treatments (CORE-ABI vs SET-ABI) in children emerged from a disorder of consciousness (N=40; sample size determined through power-analysis)
Primary purpose: TREATMENT

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.

Eligibility criteria: -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

Primary outcomes:
measure: Conners Kiddie Continuous Performance Test-2nd Edition -K-CPT-2/Continuous Performance Test-3rd Edition -CPT-3
timeFrame: before and immediately after the intervention
Secondary outcomes:
measure: BVN visual selective attention
timeFrame: before and immediately after the intervention
measure: Benton Judgment of Line Orientation Test
timeFrame: before and immediately after the intervention
measure: BVN Phonemic fluency
timeFrame: before and immediately after the intervention
measure: ToL Total moves
timeFrame: before and immediately after the intervention
measure: NEPSY-II Theory of Mind subscale
timeFrame: before and immediately after the intervention
measure: BVN Immediate word list recall task
timeFrame: before and immediately after the intervention
measure: MCST/WCST Errors
timeFrame: before and immediately after the intervention
measure: BVN Forward digit span
timeFrame: before and immediately after the intervention
measure: BVN Corsi
timeFrame: before and immediately after the intervention
measure: Rey-Osterrieth Complex Figure Test-recall task (ROCF-recall)
timeFrame: before and immediately after the intervention
measure: Rey-Osterrieth Complex Figure Test -copy task (ROCF-copy)
timeFrame: before and immediately after the intervention
measure: NEPSY-II Affect Recognition subscale
timeFrame: before and immediately after the intervention
measure: Test of Visual Perceptual Skills-3rd Edition -TVPS-3-
timeFrame: before and immediately after the intervention
measure: ToL Initiation Time
timeFrame: before and immediately after the intervention
measure: BVN Backward digit span
timeFrame: before and immediately after the intervention
measure: BVN Delayed word list recall task
timeFrame: before and immediately after the intervention
Other outcomes:
Locations:
city: Bosisio Parini
country: Italy
facility: IRCCS Eugenio Medea
Study officials:
References: