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Search / Trial NCT06635291

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

Launched by IRCCS EUGENIO MEDEA · Oct 8, 2024

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Brain Injury Disorder Of Consciousness Diagnosis Behavioral Scale Children Pediatric

ClinConnect Summary

The IDeAl DesiRE clinical trial is studying how to better diagnose children with severe brain injuries and disorders of consciousness (DoC). Researchers want to compare traditional methods of assessing these children, like certain behavioral scales, with new behaviors called Emergency Markers (E-Markers). E-Markers are specific signs that may show a child has some awareness, and they could help improve diagnosis when used alongside standard assessments. This trial will also focus on very young children under 12 months, who can't be assessed using some of the standard scales, by looking closely at their motor skills and development.

To be eligible for this trial, children must be between 2 months and 25 years old and have suffered a severe brain injury from causes like traumatic incidents or lack of oxygen. They should be in a vegetative state or a minimally conscious state when they enter the study. The trial is currently looking for participants, and families who join can expect to help advance our understanding of brain injuries in children, which could lead to better diagnosis and care in the future.

Gender

ALL

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.

About Irccs Eugenio Medea

IRCCS Eugenio Medea is a leading clinical research institute based in Italy, dedicated to advancing pediatric healthcare through innovative research and evidence-based practices. As a recognized center of excellence, it focuses on multidisciplinary approaches to address complex health challenges in children and adolescents, particularly in the fields of neurodevelopmental disorders, mental health, and rehabilitation. The institute collaborates with national and international partners to conduct rigorous clinical trials, aiming to translate scientific discoveries into effective therapeutic interventions. Committed to enhancing patient outcomes, IRCCS Eugenio Medea prioritizes ethical standards and patient safety in all its research endeavors.

Locations

Bosisio Parini, Lecco, Italy

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported