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

IRCCS Eugenio Medea

Status: Completed

Conditions: Development, Child; Acquired Brain Injury

Treatments: Other: Sequential Neuropsychological treatment (SET-ABI); Other: Personalized Neuropsychological treatment (CORE-ABI)

Study type: Interventional

Funder types: Other

Identifiers

NCT04499092

607rev1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 184 patients

Sex: All

Ages: 3 months to 17 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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184 participants in 2 patient groups

Personalized neuropsychological treatment (CORE-ABI)

Active Comparator group

Description:

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.

Treatment:

Other: Personalized Neuropsychological treatment (CORE-ABI)

Sequential neuropsychological treatment (SET-ABI)

Experimental group

Description:

Each patient will receive a fixed-dose stimulation of each cognitive function following a sequential order.

Treatment:

Other: Sequential Neuropsychological treatment (SET-ABI)