Clinical Trial

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

Study acronym: IDeAl DesiRE
Recruiting
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Record status
This record was last updated December 16, 2024 (before its estimated December 31, 2025 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2024-10-08.
Trial Details
NCT Number NCT06635291
Lead Sponsor IRCCS Eugenio Medea
Conditions Acquired Brain Injury, Disorder of Consciousness
Enrollment 113 participants
Start Date 2024-05-20
Primary Completion 2025-12-31 (estimated)
Study Completion 2026-12-31 (estimated)
Updated on ClinicalTrials.gov 2024-12-16