Improving the Diagnostic Accuracy of Children with DoC (IDeAl DesiRE)

NCT06635291 | Recruiting DMC

• 1 other identifier: 1108
• Study Type: observational
• Target: 113
• Locations: 1 country
• Sites: 1

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.

Conditions

Acquired Brain Injury; Disorder of Consciousness

Keywords

brain injury; disorder of consciousness; diagnosis; behavioral scale; children; pediatric

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  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).

Eligibility Criteria

• Age: 2 Months - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• \- ABI due to brain tumor or neurodegenerative disease.

Sponsors & Collaborators

• IRCCS Eugenio Medea: lead

Study Sites (1)

Scientific Institute, IRCCS E. Medea

Bosisio Parini, Lecco, 23842, Italy

RECRUITING

Related Publications (4)

• 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.

  PMID: 15605342 BACKGROUND

• Giacino 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.

  PMID: 30089618 BACKGROUND

• Slomine 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.

  PMID: 31462082 BACKGROUND

• Frigerio 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.

  PMID: 36335241 BACKGROUND

MeSH Terms

Conditions

Brain Injuries; Consciousness Disorders; Disease

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Pathologic Processes

Central Study Contacts

Sandra Strazzer, MD

CONTACT

+39031877111; sandra.strazzer@lanostrafamiglia.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2024
• First Posted: October 10, 2024
• Study Start: May 20, 2024
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 16, 2024

Record last verified: 2024-10

Locations

IT (1)