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Recruiting NCT06635291

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

— Observational Acquired Brain Injury Disorder of Consciousness

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Acquired Brain Injury, Disorder of Consciousness. Basic parameters: 2 months — 25 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Detailed description

The assessment of the state of consciousness (CS) after an Acquired Brain Injury (ABI) is a complex and challenging process because of the clinical complexity of patients suffering from this condition. The most widely used measure to assess disturbance of consciousness (DoC) is the Coma Recovery Scale Revised (CRS-R), which is considered the gold standard for bedside assessments. This scale, even though validated for the adult population, has been recommended also for the pediatric population, considering the absence of tools designed to address children. In 2019, to fill this gap, Slomine and collaborators developed a pediatric form of the CRS, namely the Coma Recovery Scale for Pediatrics (CRS-P), but, up to now, it has been exclusively tested in typically developing children. Another tool frequently used to assess the DoC, even in pediatric age, is the Rappaport Coma Near Coma Scale (CNCS). In a recent study of our group, a statistically significant agreement between the CRS-R and the CNCS was found; however, the CNCS was found to better define patients' status in the emergency phase from minimally conscious state, while the CRS-R demonstrated to have lower DoC scoring ability in the presence of severe motor impairment. These results suggest new challenges for the diagnostic process, considering that the risk of misdiagnosis is still high.

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; for this subgroup of children a small sample size is expected, which could not allow obtaining precise statistical data; however, results could lead to draw some relevant preliminary considerations.

For the whole sample, the effects of the various clinical, demographic and personal variables will be evaluated on functional outcome, intended as level of consciousness, disability degree and recovery level. Data based on neurophysiological and/or neuroimaging data will also be considered.

The investigators hypothesize that E-Markers may help clinicians to evaluate patients' clinical evolution earlier than behavioral scales.

Primary outcome measures

  • Coma Recovery Scale-Revised (CRS-R) [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).]
  • Rappaport Coma/Near Coma Scale (CNCS) [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).]
  • Coma Recovery Scale for Pediatrics (CRS-P) [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).]

Eligibility criteria

Inclusion criteria

  • 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 criteria

\- ABI due to brain tumor or neurodegenerative disease.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Italy · 1 center
  • Scientific Institute, IRCCS E. Medea — Bosisio Parini

Publications

  • Giacino JT, Kalmar K, Whyte J. The JFK Coma Recovery Scale-Revised: measurement characteristics and diagnostic utility. Arch Phys Med Rehabil. 2004 Dec;85(12):2020-9. doi: 10.1016/j.apmr.2004.02.033. PMID 15605342
  • Giacino JT, Katz DI, Schiff ND, Whyte J, Ashman EJ, Ashwal S, Barbano R, Hammond FM, Laureys S, Ling GSF, Nakase-Richardson R, Seel RT, Yablon S, Getchius TSD, Gronseth GS, Armstrong MJ. Practice guideline update recommendations summary: Disorders of consciousness: Report of the Guideline Development, Dissemination, and Implementation Subcommittee of the American Academy of Neurology; the American PMID 30089618
  • Slomine BS, Suskauer SJ, Nicholson R, Giacino JT. Preliminary validation of the coma recovery scale for pediatrics in typically developing young children. Brain Inj. 2019;33(13-14):1640-1645. doi: 10.1080/02699052.2019.1658221. Epub 2019 Aug 28. PMID 31462082
  • Frigerio S, Molteni E, Colombo K, Pastore V, Fedeli C, Galbiati S, Strazzer S. Neuropsychological assessment through Coma Recovery Scale-Revised and Coma/Near Coma Scale in a sample of pediatric patients with disorder of consciousness. J Neurol. 2023 Feb;270(2):1019-1029. doi: 10.1007/s00415-022-11456-6. Epub 2022 Nov 5. PMID 36335241

Identifiers

NCT: NCT06635291 · 1108

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗