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

NCT ID: NCT04499092

Last Updated: 2024-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

184 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-01

Study Completion Date

2023-12-31

Brief Summary

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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

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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.

Conditions

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Acquired Brain Injury Development, Child

Keywords

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Rehabilitation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors
Caregivers of participants are blinded to treatment allocation.

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Personalized Neuropsychological treatment (CORE-ABI)

Intervention Type OTHER

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.

Sequential neuropsychological treatment (SET-ABI)

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

Group Type EXPERIMENTAL

Sequential Neuropsychological treatment (SET-ABI)

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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:


* 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
Minimum Eligible Age

3 Months

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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IRCCS Eugenio Medea

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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IRCCS Eugenio Medea

Bosisio Parini, Italy, Italy

Site Status

Countries

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Italy

Other Identifiers

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607rev1

Identifier Type: -

Identifier Source: org_study_id