Improving the Diagnostic Accuracy of Children with DoC (IDeAl DesiRE)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age2-25
SponsorIRCCS Eugenio Medea
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
None
Trial population
Study population is composed of children and young adults suffering from an ABI admitted in the research timeframe to Scientifc Institute, IRCCS E. Medea, Bosisio Parini, Lecco, Italy. A total of 113 patients is required for the study. The calculation of the sample size was based on the comparison of the diagnostic capacity of the CRS-R with addition of E-markers and CRS-R without the addition of E-markers. This comparison has been analyzed using the area under the ROC curve. Assuming a percentage of patients emerging from a disorder of consciousness within the first 3 months after the ABI of 40% and an AUC of the CRS-R scale without the addition of E-markers of 0.7 (internal historical data), to identify a difference in the AUC of 0.15, with a power of 80% and a type I error of 5%, it is necessary to enroll 113 subjects.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Coma Recovery Scale-Revised (CRS-R)
The CRS-R is a behavioral scale used to assess level of consciousness in patients with disorders of consciousness. It consists of 6 subscales designed to assess auditory function, receptive and expressive language, visuoperception, communication ability, motor functions, and arousal level.
Time frame
CRS-R is administered at the time of admission (T0) and at 2 months (T1), 3 months (T3) and 6 months after the event (T4).2
Rappaport Coma/Near Coma Scale (CNCS)
The Rappaport Coma/Near Coma Scale is a behavioral scale designed to assess neurobehavioral status among patients who have sustained a severe brain injury, being in vegetative or near-vegetative state. It is composed of 11 items, assessing dysfunction in the sensory and perceptual domains, and describes the severity of primitive response deficits. Each item is scored on a 3-point rating scale (0, 2, and 4), with lower scores indicating better neurobehavioral functioning. A final level of Awareness/Responsivity is provided, ranging from 0 to 5, with lower scores indicating lower functioning.
Time frame
CNCS is administered at the time of admission (T0) and at 2 months (T1), 3 months (T3) and 6 months after the event (T4).3
Coma Recovery Scale for Pediatrics (CRS-P)
The CRS-P is a modified version of the Coma Recovery Scale-Revised (CRS-R), developed by Slomine and colleagues in 2019 to better evaluate the population of children with disorders of consciousness compared to the original scale, which was designed for the adults. It consists of 6 subscales designed to assess auditory function, receptive and expressive language, visuoperception, communication ability, motor functions, and arousal level, as for the CRS-R. Modifications include stimuli used, administration guidelines and scoring criteria. The overall score ranges from 0 to 23. Lower scores indicate worse functioning.
Time frame
CRS-P is administered at the time of admission (T0) and at 2 months (T1), 3 months (T3) and 6 months after the event (T4).Sponsors and contacts
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Source ClinicalTrials.gov