COgnitive REhabilitation in Pediatric Patients With sABI From Vegetative State to Functional Recovery

  • STATUS
    Recruiting
  • End date
    Jul 1, 2023
  • participants needed
    80
  • sponsor
    IRCCS Eugenio Medea
Updated on 3 September 2021
vegetative state
coma
cognitive rehabilitation

Summary

Acquired brain lesions (GCLA) represent one of the most important cause of disability and mortality during the pediatric age, also in the western Countries. The important medical progresses of the last decade in the medical field have increased the percentages of survival, also in the most severe clinical pictures. On the other hand, a brain lesion reported in the first years of life presents with a more dramatic impact on the cognitive and neurological development of the patients and it can significantly interfere with the same quality of their life. Recent studies suggest that a brain damage in this stage of the life is related to more persistent sequelae in comparison of the same lesion reported by an adult patient, because of the neurological immaturity at the moment of the insult. Furthermore, in most cases, the brain lesion is related not only to motor and sensorial deficits but also to very important behavioral and cognitive problems, that can arise immediately after the acute phase, or also several years after the pathological event.

Description

The aims of the present study are:

  1. To contribute to the adaptation of the Italian version of the Coma Recovery Scale (CRS-R) for the pediatric age, with specific differentiation and taking into account the age of the patients and the specific learning that characterize each developmental stage;
  2. As regards the patients with an adequate cognitive profile, to compare the effectiveness of a traditional multifunction neuropsychological treatment (cognitive functions are stimulated at the same time) vs a sequential treatment (cognitive functions are stimulated step by step).

Details
Condition Child Development, Brain Injury, brain damage, brain damages, cerebral injury, acquired brain injury
Treatment Neuropsychological treatment
Clinical Study IdentifierNCT04499092
SponsorIRCCS Eugenio Medea
Last Modified on3 September 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

For the adaptation of the CRS-R
Healthy subjects
children aged between 0 and 5 years (N=48)
normal development
Clinical subjects
Age between 0 and 10 at the moment of the pathological event
LOCFAS score <5
A documented diagnosis of severe acquired brain lesion of traumatic, anoxic, vascular or infective etiology (Glasgow Coma Scale, GCS<12)
Brain lesion reported within one year from the day of the inclusion in the study
For the comparison between multifunction treatment vs sequential treatment
Age between 5 and 18 years at the moment of the pathological event
LOCFAS score>5
time between the GCLA and the assessment < 3 months
Documented GCLA
GCS <12 in the acute phase
Negative anamnesis for other developmental disorders before the GCLA
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