Ignite Creation Date:
2024-10-25 @ 8:02 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06635291
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-10
Brief Title:
Improving the Diagnostic Accuracy of Children with DoC IDeAl DesiRE
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Improving the Diagnostic Accuracy of Children with Disorders of Consciousness in the REhabilitation Process IDeAl DesiRE
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IDeAl DesiRE
Brief Summary:
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
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 andor neuroimaging data will also be considered
The investigators hypothesize that E-Markers may help clinicians to evaluate patients clinical evolution earlier than behavioral scales
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 andor neuroimaging data will also be considered
The investigators hypothesize that E-Markers may help clinicians to evaluate patients clinical evolution earlier than behavioral scales
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None