Clinical trial Recruiting at 1 site Observational Ages 2 Months to 25

Improving diagnosis of children with brain injuries and disorders of consciousness

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

Run by IRCCS Eugenio Medea · NCT06635291 · Data updated 2026-11-12

This study is trying to find better ways to diagnose brain injuries and disorders of consciousness in young children by using new markers alongside existing tests.

More Acquired Brain Injury trials

Quick facts

Study typeObservational
Ages2 Months to 25 Years
SexAll
Enrollment113 (estimated)
SponsorIRCCS Eugenio Medea
Academic / other
Locations1 site (Bosisio Parini, Lecco)
StatusRecruiting
StartedMay 20, 2024
Main results expectedDecember 31, 2025
Study endsDecember 31, 2026
Registry record updatedDecember 16, 2024
Trial IDNCT06635291 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates include children aged 2 months to 25 years with severe ABI and currently in a vegetative or minimally conscious state.

Probably not a fit

Patients with ABI due to brain tumors or neurodegenerative diseases may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the clinical evolution of children with severe acquired brain injury (ABI) and disorders of consciousness (DoC) by utilizing traditional behavioral scales such as the Coma Recovery Scale Revised (CRS-R) and the Coma Recovery Scale for Pediatrics (CRS-P). It aims to identify clinical markers of emergency (E-Markers) that indicate consciousness, which could enhance diagnostic accuracy when combined with existing scales. Special attention will be given to children under 12 months, focusing on developmental stages and motor abilities. The study seeks to address the high risk of misdiagnosis in this vulnerable population.

Why it matters

Potential benefit: If successful, this study could lead to improved diagnostic accuracy for children with brain injuries, facilitating better treatment and care.

How similar studies have gone: While the approach of identifying E-Markers is novel, previous studies have shown the importance of accurate assessment tools in similar populations.

Who can join: the full rules

Show full inclusion / exclusion 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.

Where it's running

  • Scientific Institute, IRCCS E. Medea
    Bosisio Parini, Lecco, Italy
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.