Acquired Brain InjuryIDeAl DesiRENCT06635291
Improving the Diagnostic Accuracy of Children with DoC (IDeAl DesiRE)
An observational study of Acquired Brain Injury and Disorder of Consciousness, run by IRCCS Eugenio Medea at 1 site in Italy.
Trial 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). Read more about this study
- Who is it for?
- Ages 2 months to 25 years
- Conditions the study is for
- Acquired Brain Injury, Disorder of Consciousness
- How many people
- 113 participants
- Where
- 1 siteItaly
- Study dates
- 20 May 2024to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 months to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Study population is composed of children and young adults suffering from an ABI admitted in the research timeframe to Scientifc Institute, IRCCS E. Medea, Bosisio Parini, Lecco, Italy. A total of 113 patients is required for the study. The calculation of the sample size was based on the comparison of the diagnostic capacity of the CRS-R with addition of E-markers and CRS-R without the addition of E-markers. This comparison has been analyzed using the area under the ROC curve. Assuming a percentage of patients emerging from a disorder of consciousness within the first 3 months after the ABI of 40% and an AUC of the CRS-R scale without the addition of E-markers of 0.7 (internal historical data), to identify a difference in the AUC of 0.15, with a power of 80% and a type I error of 5%, it is necessary to enroll 113 subjects.
Who may be able to join
- 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.
Who cannot join
- ABI due to brain tumor or neurodegenerative disease.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Scientific Institute, IRCCS E. Medea
Bosisio Parini, Lecco, 23842
Sandra Strazzer, MD, + 39 031877111, sandra.strazzer@lanostrafamiglia.it
About this study
Official title: Improving the Diagnostic Accuracy of Children with Disorders of Consciousness in the REhabilitation Process (IDeAl DesiRE)
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.
Read the 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 and/or neuroimaging data will also be considered.
The investigators hypothesize that E-Markers may help clinicians to evaluate patients' clinical evolution earlier than behavioral scales.
- Conditions
- Acquired Brain Injury, Disorder of Consciousness
- Keywords
- brain injury, disorder of consciousness, diagnosis, behavioral scale, children, pediatric
- Medical subject headings
- Brain Injuries, Consciousness Disorders, Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Coma Recovery Scale-Revised (CRS-R)
The CRS-R is a behavioral scale used to assess level of consciousness in patients with disorders of consciousness. It consists of 6 subscales designed to assess auditory function, receptive and expressive language, visuoperception, communication ability, motor functions, and arousal level.
Measured: CRS-R is administered at the time of admission (T0) and at 2 months (T1), 3 months (T3) and 6 months after the event (T4).
Rappaport Coma/Near Coma Scale (CNCS)
The Rappaport Coma/Near Coma Scale is a behavioral scale designed to assess neurobehavioral status among patients who have sustained a severe brain injury, being in vegetative or near-vegetative state. It is composed of 11 items, assessing dysfunction in the sensory and perceptual domains, and describes the severity of primitive response deficits. Each item is scored on a 3-point rating scale (0, 2, and 4), with lower scores indicating better neurobehavioral functioning. A final level of Awareness/Responsivity is provided, ranging from 0 to 5, with lower scores indicating lower functioning.
Measured: CNCS is administered at the time of admission (T0) and at 2 months (T1), 3 months (T3) and 6 months after the event (T4).
Coma Recovery Scale for Pediatrics (CRS-P)
The CRS-P is a modified version of the Coma Recovery Scale-Revised (CRS-R), developed by Slomine and colleagues in 2019 to better evaluate the population of children with disorders of consciousness compared to the original scale, which was designed for the adults. It consists of 6 subscales designed to assess auditory function, receptive and expressive language, visuoperception, communication ability, motor functions, and arousal level, as for the CRS-R. Modifications include stimuli used, administration guidelines and scoring criteria. The overall score ranges from 0 to 23. Lower scores indicate worse functioning.
Measured: CRS-P is administered at the time of admission (T0) and at 2 months (T1), 3 months (T3) and 6 months after the event (T4).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2024
- Study start20 May 2024
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Acquired Brain InjuryStudies of the same condition, open and under way.
- More trials run by IRCCS Eugenio MedeaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 113 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS Eugenio Medea
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06635291
- Sponsor's protocol ID
- 1108
- Acronym
- IDeAl DesiRE
- Status last verified
- Oct 2024
- First submitted
- 10 Sep 2024
- Last updated
- 16 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Giacino JT, Kalmar K, Whyte J. The JFK Coma Recovery Scale-Revised: measurement characteristics and diagnostic utility. Arch Phys Med Rehabil. 2004 Dec;85(12):2020-9. doi: 10.1016/j.apmr.2004.02.033.
PubMed 15605342Giacino JT, Katz DI, Schiff ND, Whyte J, Ashman EJ, Ashwal S, Barbano R, Hammond FM, Laureys S, Ling GSF, Nakase-Richardson R, Seel RT, Yablon S, Getchius TSD, Gronseth GS, Armstrong MJ. Practice guideline update recommendations summary: Disorders of consciousness: Report of the Guideline Development, Dissemination, and Implementation Subcommittee of the American Academy of Neurology; the American Congress of Rehabilitation Medicine; and the National Institute on Disability, Independent Living, and Rehabilitation Research. Neurology. 2018 Sep 4;91(10):450-460. doi: 10.1212/WNL.0000000000005926. Epub 2018 Aug 8.
PubMed 30089618Slomine BS, Suskauer SJ, Nicholson R, Giacino JT. Preliminary validation of the coma recovery scale for pediatrics in typically developing young children. Brain Inj. 2019;33(13-14):1640-1645. doi: 10.1080/02699052.2019.1658221. Epub 2019 Aug 28.
PubMed 31462082Frigerio S, Molteni E, Colombo K, Pastore V, Fedeli C, Galbiati S, Strazzer S. Neuropsychological assessment through Coma Recovery Scale-Revised and Coma/Near Coma Scale in a sample of pediatric patients with disorder of consciousness. J Neurol. 2023 Feb;270(2):1019-1029. doi: 10.1007/s00415-022-11456-6. Epub 2022 Nov 5.
PubMed 36335241
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving the Diagnostic Accuracy of Children with Disorders of Consciousness in the REhabilitation Process (IDeAl DesiRE)
- ClinicalTrials.gov ID
- NCT06635291
- Acronym / sponsor ID
- IDeAl DesiRE / 1108
- Conditions
- Acquired Brain Injury, Disorder of Consciousness
- Keywords
- brain injury, disorder of consciousness, diagnosis, behavioral scale, children, pediatric
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 113 participants (estimated)
- Lead sponsor
- IRCCS Eugenio MedeaUniversity, hospital or other
- Study start
- 20 May 2024 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 10 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 and/or 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 2 months to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Study population is composed of children and young adults suffering from an ABI admitted in the research timeframe to Scientifc Institute, IRCCS E. Medea, Bosisio Parini, Lecco, Italy. A total of 113 patients is required for the study. The calculation of the sample size was based on the comparison of the diagnostic capacity of the CRS-R with addition of E-markers and CRS-R without the addition of E-markers. This comparison has been analyzed using the area under the ROC curve. Assuming a percentage of patients emerging from a disorder of consciousness within the first 3 months after the ABI of 40% and an AUC of the CRS-R scale without the addition of E-markers of 0.7 (internal historical data), to identify a difference in the AUC of 0.15, with a power of 80% and a type I error of 5%, it is necessary to enroll 113 subjects.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (1 listed)
- ABI due to brain tumor or neurodegenerative disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Coma Recovery Scale-Revised (CRS-R)
Time frame: CRS-R is administered at the time of admission (T0) and at 2 months (T1), 3 months (T3) and 6 months after the event (T4).
The CRS-R is a behavioral scale used to assess level of consciousness in patients with disorders of consciousness. It consists of 6 subscales designed to assess auditory function, receptive and expressive language, visuoperception, communication ability, motor functions, and arousal level.
Rappaport Coma/Near Coma Scale (CNCS)
Time frame: CNCS is administered at the time of admission (T0) and at 2 months (T1), 3 months (T3) and 6 months after the event (T4).
The Rappaport Coma/Near Coma Scale is a behavioral scale designed to assess neurobehavioral status among patients who have sustained a severe brain injury, being in vegetative or near-vegetative state. It is composed of 11 items, assessing dysfunction in the sensory and perceptual domains, and describes the severity of primitive response deficits. Each item is scored on a 3-point rating scale (0, 2, and 4), with lower scores indicating better neurobehavioral functioning. A final level of Awareness/Responsivity is provided, ranging from 0 to 5, with lower scores indicating lower functioning.
Coma Recovery Scale for Pediatrics (CRS-P)
Time frame: CRS-P is administered at the time of admission (T0) and at 2 months (T1), 3 months (T3) and 6 months after the event (T4).
The CRS-P is a modified version of the Coma Recovery Scale-Revised (CRS-R), developed by Slomine and colleagues in 2019 to better evaluate the population of children with disorders of consciousness compared to the original scale, which was designed for the adults. It consists of 6 subscales designed to assess auditory function, receptive and expressive language, visuoperception, communication ability, motor functions, and arousal level, as for the CRS-R. Modifications include stimuli used, administration guidelines and scoring criteria. The overall score ranges from 0 to 23. Lower scores indicate worse functioning.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2024.
- Background: PubMed 15605342Giacino JT, Kalmar K, Whyte J. The JFK Coma Recovery Scale-Revised: measurement characteristics and diagnostic utility. Arch Phys Med Rehabil. 2004 Dec;85(12):2020-9. doi: 10.1016/j.apmr.2004.02.033.
- Background: PubMed 30089618Giacino JT, Katz DI, Schiff ND, Whyte J, Ashman EJ, Ashwal S, Barbano R, Hammond FM, Laureys S, Ling GSF, Nakase-Richardson R, Seel RT, Yablon S, Getchius TSD, Gronseth GS, Armstrong MJ. Practice guideline update recommendations summary: Disorders of consciousness: Report of the Guideline Development, Dissemination, and Implementation Subcommittee of the American Academy of Neurology; the American Congress of Rehabilitation Medicine; and the National Institute on Disability, Independent Living, and Rehabilitation Research. Neurology. 2018 Sep 4;91(10):450-460. doi: 10.1212/WNL.0000000000005926. Epub 2018 Aug 8.
- Background: PubMed 31462082Slomine BS, Suskauer SJ, Nicholson R, Giacino JT. Preliminary validation of the coma recovery scale for pediatrics in typically developing young children. Brain Inj. 2019;33(13-14):1640-1645. doi: 10.1080/02699052.2019.1658221. Epub 2019 Aug 28.
- Background: PubMed 36335241Frigerio S, Molteni E, Colombo K, Pastore V, Fedeli C, Galbiati S, Strazzer S. Neuropsychological assessment through Coma Recovery Scale-Revised and Coma/Near Coma Scale in a sample of pediatric patients with disorder of consciousness. J Neurol. 2023 Feb;270(2):1019-1029. doi: 10.1007/s00415-022-11456-6. Epub 2022 Nov 5.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acquired Brain Injury and Disorder of Consciousness, run by IRCCS Eugenio Medea at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sandra Strazzer, MD (+39031877111, sandra.strazzer@lanostrafamiglia.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Coma Recovery Scale-Revised (CRS-R) (time frame: CRS-R is administered at the time of admission (T0) and at 2 months (T1), 3 months (T3) and 6 months after the event (T4).). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06635291, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2024.