Improving diagnosis of children with brain injuries and disorders of consciousness
Improving the Diagnostic Accuracy of Children with Disorders of Consciousness in the REhabilitation Process (IDeAl DesiRE)
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.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 113 (estimated) |
| Ages | 2 Months to 25 Years |
| Sex | All |
| Sponsor | IRCCS Eugenio Medea Academic / other |
| Locations | 1 site (Bosisio Parini, Lecco) |
| Trial ID | NCT06635291 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include children aged 2 months to 25 years with severe ABI and currently in a vegetative or minimally conscious state.
Not a fit: Patients with ABI due to brain tumors or neurodegenerative diseases may not benefit from this study.
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 performed: While the approach of identifying E-Markers is novel, previous studies have shown the importance of accurate assessment tools in similar populations.
Eligibility criteria
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 this trial is running
Bosisio Parini, Lecco
- Scientific Institute, IRCCS E. Medea — Bosisio Parini, Lecco, Italy (Recruiting)
Study contacts
- Study coordinator: Sandra Strazzer, MD
- Email: sandra.strazzer@lanostrafamiglia.it
- Phone: +39031877111
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.