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.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 2 Months to 25 Years |
| Sex | All |
| Enrollment | 113 (estimated) |
| Sponsor | IRCCS Eugenio Medea Academic / other |
| Locations | 1 site (Bosisio Parini, Lecco) |
| Status | Recruiting |
| Started | May 20, 2024 |
| Main results expected | December 31, 2025 |
| Study ends | December 31, 2026 |
| Registry record updated | December 16, 2024 |
| Trial ID | NCT06635291 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
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Scientific Institute, IRCCS E. Medea
Bosisio Parini, Lecco, Italy Recruiting
Study contacts
- Study coordinator: Sandra Strazzer, MD
- Email: sandra.strazzer@lanostrafamiglia.it
- Phone: +39031877111
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Music therapy for children with disorders of consciousness
This study tests whether live or recorded familiar music helps children with disorders of consciousness after severe brain injury to wake up or engage more.
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Comparing robotic and traditional methods for helping patients with severe brain injuries stand up
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Caregivers and patients with severe brain injury: using the SAFE scale to monitor behavior together
A caregiver-friendly tool called the SAFE scale is tested to see if involving family members in daily observations helps care teams track DoC patients more consistently.
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This project will try delivering cognitive and speech therapy through a web-based platform called Cognishine for adults in hospital after stroke or other acquired brain injury.
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This trial tests Inrobics Rehab, a robot-assisted home and clinic therapy, to see if it helps children aged 7-16 with acquired brain injury improve motor, thinking, and social skills while being easy to use.
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This study will see if combining voice recordings, breathing tests, and a clinical speech check can help identify the type and severity of dysarthria in adults after an acquired brain injury.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.