Validation of a Clinical Complications Scale (CCS) in Patients With Disorders of Consciousness

NCT06167200 | Completed DMC

• 1 other identifier: SCC_DOC
• Study Type: observational
• Target: 42
• Locations: 1 country
• Sites: 6

Brief Summary

The clinical condition of severe cognitive-motor impairment of Disorders of Consciousness (DoC; e.g., Vegetative State - VS, and Minimal Consciousness State - MCS), is characterized by a high risk of developing clinical complications. In this study, the investigators propose a new Clinical Complications Scale (CCS) developed to assess the impact of clinical complications on the long-term evolution of a cohort of patients with DoC. This is a multi-site prospective observational study conducted in patients with Severe Acquired Brain Injury and DoC admitted to six centers of Fondazione Don Gnocchi (Italy), with clinical data collection not deviating from routine practice (except for CCS administration). The study is non-commercial and will have a maximum total duration of 24 months. It is planned to assess inter-rater agreement and concurrent validity with a similar instrument (CoCoS scale).

Conditions

Disorders of Consciousness

Keywords

Disorders of Consciousness; clinical complications

Outcome Measures

Primary Outcomes (2)

• inter-rater reliability

  agreement in scores between different examiners

  15 days from enrolment

• concurrent validity

  correlation between scores on the CCS and the CoCoS

  15 days from enrolment

Study Arms (1)

Patients with DoC consecutively admitted to participating units and met the inclusion criteria

Patients in VS or MCS due to severe acquired brain injury with different etiology (traumatic, anoxic, vascular) consecutively admitted at participating neurorehabilitation units. The total sample will be composed of 42 patients (n=7 pts per participating unit).

Other: No intervention, study is observational

Interventions

No intervention, study is observational OTHER

No intervention, study is observational

Patients with DoC consecutively admitted to participating units and met the inclusion criteria

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients in VS or MCS due to severe acquired brain injury with different etiology (traumatic, anoxic, vascular) consecutively admitted at participating neurorehabilitation units. The total sample will be composed of 42 patients (n=7 pts per participating unit).

You may qualify if:

• Clinical diagnosis of VS or MCS, in accordance with international standard diagnostic criteria (Giacino et al., 2002) and confirmed by Coma Recovery Scale-Revised (CRS-R; Giacino et al., 2004) assessment repeated 3-5 times within a week (Wannez et al., 2017);
• Time post-injury ≥28 days;
• age ≥18 years;
• Traumatic, vascular, anoxic, or mixed etiology.

You may not qualify if:

• Absence of the informed consent by the patient's legal representative.

Sponsors & Collaborators

• Fondazione Don Carlo Gnocchi Onlus: lead

Study Sites (6)

Polo Specialistico Riabilitativo Fondazione Don Carlo Gnocchi ONLUS

Sant'Angelo dei Lombardi, Avellino, 83054, Italy

Location

IRCCS Fondazione Don Carlo Gnocchi Firenze

Florence, Italy

Location

Polo Riabilitativo del Levante Ligure Fondazione Don Gnocchi

La Spezia, Italy

Location

IRCCS S. Maria Nascente Fondazione Don Gnocchi

Milan, Italy

Location

Istituto Palazzolo Fondazione Don Gnocchi

Milan, Italy

Location

Centro Spalenza Fondazione Don Gnocchi

Rovato, Italy

Location

Related Publications (5)

• Giacino JT, Ashwal S, Childs N, Cranford R, Jennett B, Katz DI, Kelly JP, Rosenberg JH, Whyte J, Zafonte RD, Zasler ND. The minimally conscious state: definition and diagnostic criteria. Neurology. 2002 Feb 12;58(3):349-53. doi: 10.1212/wnl.58.3.349.

  PMID: 11839831 BACKGROUND

• Wannez S, Heine L, Thonnard M, Gosseries O, Laureys S; Coma Science Group collaborators. The repetition of behavioral assessments in diagnosis of disorders of consciousness. Ann Neurol. 2017 Jun;81(6):883-889. doi: 10.1002/ana.24962.

  PMID: 28543735 BACKGROUND

• Pistoia F, Carolei A, Bodien YG, Greenfield S, Kaplan S, Sacco S, Pistarini C, Casalena A, De Tanti A, Cazzulani B, Bellaviti G, Sara M, Giacino J. The Comorbidities Coma Scale (CoCoS): Psychometric Properties and Clinical Usefulness in Patients With Disorders of Consciousness. Front Neurol. 2019 Oct 17;10:1042. doi: 10.3389/fneur.2019.01042. eCollection 2019.

  PMID: 31681139 BACKGROUND

• Estraneo A, Loreto V, Masotta O, Pascarella A, Trojano L. Do Medical Complications Impact Long-Term Outcomes in Prolonged Disorders of Consciousness? Arch Phys Med Rehabil. 2018 Dec;99(12):2523-2531.e3. doi: 10.1016/j.apmr.2018.04.024. Epub 2018 May 26.

  PMID: 29807003 BACKGROUND

• 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

MeSH Terms

Conditions

Consciousness Disorders

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Study Officials

• Anna Estraneo, MD

  Fondazione Don Carlo Gnocchi Onlus

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 15 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Neurologist, Senior Researcher

Study Record Dates

• First Submitted: December 4, 2023
• First Posted: December 12, 2023
• Study Start: May 15, 2024
• Primary Completion: November 30, 2024
• Study Completion: December 30, 2024
• Last Updated: February 6, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (6)