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

Recruiting now

Conditions studied: Acquired Brain Injury, Disorder of Consciousness

In brief

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.

Key facts

Study ID

NCT06635291

Run by

IRCCS Eugenio Medea

People needed

113

Starts

2024-05-20

Expected to finish

2026-12-31

Last updated by the study team

2024-12-16

Who can join

Age: 0 and older, up to 25. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• ABI due to brain tumor or neurodegenerative disease.

Where it is running

• Scientific Institute, IRCCS E. Medea — Bosisio Parini, Lecco, Italy (enrolling)

Full record on ClinicalTrials.gov

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