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

NCT04499092 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 184

Last updated 2024-12-13

No results posted yet for this study

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.

Conditions

  • Acquired Brain Injury
  • Development, Child

Interventions

OTHER

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.

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.

Sponsors & Collaborators

  • IRCCS Eugenio Medea

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
3 Months
Max Age
17 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-10-01
Primary Completion
2022-02-28
Completion
2023-12-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04499092 on ClinicalTrials.gov