RecruitingNCT06635291

Improving the Diagnostic Accuracy of Children with DoC (IDeAl DesiRE)

Improving the Diagnostic Accuracy of Children with Disorders of Consciousness in the REhabilitation Process (IDeAl DesiRE)


Sponsor

IRCCS Eugenio Medea

Enrollment

113 participants

Start Date

May 20, 2024

Study Type

OBSERVATIONAL

Conditions

Summary

The present study aims to investigate the clinical evolution of children with severe ABI and DoC both by using the traditional behavioral scales, namely the CRS-R, CRS-P and CNCS, and by trying to establish whether it is possible to identify any clinical markers of Emergency (E-Markers). E-Markers are behaviors that indicate a content of consciousness irrespective of the processes investigated by behavioral scales, thus they could be combined with the items of these scales to improve the diagnosis. A particular focus will be given to the identification of specific E-Markers for children aged less than 12 months, for which the CRS-P scale cannot be used. In this case, the E-markers will be compared with the specific developmental stages of newborns, giving great importance to motor abilities.


Eligibility

Min Age: 2 MonthsMax Age: 25 Years

Inclusion Criteria5

  • suffering from an ABI due to: traumatic brain injury, hypoxic events/anoxia, cerebral infections, cerebrovascular accident;
  • age: 2 months-25.11 years;
  • having a Glasgow Coma Scale (GCS; Teasdale \& Jennett, 1974) at injury or onset ≤8);
  • being in vegetative state (VS) or minimally conscious state (MCS) at admission;
  • being in subacute or chronic phase.

Exclusion Criteria1

  • \- ABI due to brain tumor or neurodegenerative disease.

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Locations(1)

Scientific Institute, IRCCS E. Medea

Bosisio Parini, Lecco, Italy

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NCT06635291


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