Disorders of ConsciousnessSCC_DOCNCT06167200
Validation of a Clinical Complications Scale (CCS) in Patients With Disorders of Consciousness
An observational study of Disorders of Consciousness, run by Fondazione Don Carlo Gnocchi ETS at 6 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Disorders of Consciousness
- How many people
- 42 participants
- Where
- 6 sitesItaly
- Study dates
- 15 May 2024to 30 Dec 2024
- How long will I take part?
- 15 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- 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.
Who cannot join
- Absence of the informed consent by the patient's legal representative.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Italy6 sites
IRCCS Fondazione Don Carlo Gnocchi Firenze
Florence
Polo Riabilitativo del Levante Ligure Fondazione Don Gnocchi
La Spezia
IRCCS S. Maria Nascente Fondazione Don Gnocchi
Milan
Istituto Palazzolo Fondazione Don Gnocchi
Milan
Centro Spalenza Fondazione Don Gnocchi
Rovato
Polo Specialistico Riabilitativo Fondazione Don Carlo Gnocchi ONLUS
Sant'Angelo dei Lombardi, Avellino, 83054
About this study
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).
Read the detailed description
Validation of a scale for the assessment of clinical complications (Clinical Complications Scale, CCS) on a sample of DoC patients with:
- assessment of inter-rater agreement;
- assessment of concurrent validity with a similar instrument (CoCoS).
This study will be implemented throutgh three phases:
(i) Identification of a group of evaluators at participating centers (n=3 per center; total n=18) and training them to administer the CCS and CoCos scales by group videoconference; (ii) Recruitment of a sample of DoC patients (n=7 per center; total n=42) who will each undergo assessment with CCS (administered twice by two independent assessors, A and B) and with CoCoS (administered by a third independent assessor, C); (iii) Evaluation of the degree of agreement between observers in administering the CCS scale (agreement between evaluators A and B) and evaluation of concurrent validity between CCS and CoCoS scale (agreement between evaluators A/B and C).
The study involves the collection of the following clinical data for each patient on admission and during the following 15 days:
- Demographic data respecting patient anonymity (patient's numeric identification code, age, sex, ethnicity, education);
- Anamnestic data (date and etiology of acute event);
- Clinical data including blood chemistry tests, clinical complications and related therapies administered as per normal clinical reports in use at enrolling units, and referring to the 15-day period following the date of enrollment. Each patient also will be evaluated with CRS-R scale 3-5 times within one week after enrollment for confirmation of the diagnosis of DoC. Assessments with CCS and CoCoS clinical scales completed on clinical reports referring to medical complications that occurred within 15 days of enrollment.
The CCS provides a record of clinical complications in 11 categories corresponding to systems of the body (metabolic abnormalities, disorders-cardiovascular, skin and musculoskeletal problems, gastrointestinal disorders, genito-urinary disorders, respiratory disorders) or categories of clinical problems frequently encountered in the population of patients with DoC (neurosurgical complications, epilepsy and myoclonus, paraosteortropathy, neurovegetative crisis, sepsis; Estraneo et al., 2018). For each category, the severity of complications is graded from 0 (absent complication) to 3 (severe complication) based on the intensity of the therapeutic intervention required, interference with the clinic, and/or frequency and duration of morbid events (an exception is the "sepsis" category for which only presence/absence is recorded). In the case of multiple clinical complications occurring within the same category, the most severe will be considered for the severity score. In this way, a cumulative scale score with range 0-31 can be derived.
Descriptive data from the sample at study entry will be expressed in terms of mean and standard deviation for quantitative variables and as frequencies for nominal variables. For the assessment of inter-rater agreement in the administration of the CCS, Fleiss' weighted K-index will be calculated on the individual subscale scores and the total score of the scale administered to each patient by two different operators. For concurrent validity testing between the CCS and CoCoS scales, Fleiss' weighted K-index will be calculated between the scores at the subscales in common between the two instruments, while Spearman's correlation coefficient for ranks will be calculated on the total scores obtained by patients on the two scales.
- Conditions
- Disorders of Consciousness
- Being tested
- No intervention, study is observational
- Keywords
- Disorders of Consciousness, clinical complications
- Medical subject headings
- Consciousness Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention, study is observationalOther
No intervention, study is observational
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Other: No intervention, study is observational |
What is being measured
The primary outcome is the main question the study is designed to answer.
inter-rater reliability
agreement in scores between different examiners
Measured: 15 days from enrolment
concurrent validity
correlation between scores on the CCS and the CoCoS
Measured: 15 days from enrolment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2023
- Study start15 May 2024
- Primary completion30 Nov 2024
- Study completion30 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Disorders of ConsciousnessStudies of the same condition, open and under way.
- More trials run by Fondazione Don Carlo Gnocchi ETSThe 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
- Cross-sectional
- Enrolment
- 42 participants (actual)
- Target duration
- 15 Days
Sponsor and investigators
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETS
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anna Estraneo, Fondazione Don Carlo Gnocchi ETS
- Investigators
- Anna Estraneo, MD, Principal investigator, Fondazione Don Carlo Gnocchi ETS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06167200
- Sponsor's protocol ID
- SCC_DOC
- Acronym
- SCC_DOC
- Status last verified
- Feb 2025
- First submitted
- 4 Dec 2023
- Last updated
- 6 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 11839831Wannez 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.
PubMed 28543735Pistoia 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.
PubMed 31681139Estraneo 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.
PubMed 29807003Giacino 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 15605342
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of a Clinical Complications Scale (CCS) in Patients With Disorders of Consciousness
- ClinicalTrials.gov ID
- NCT06167200
- Acronym / sponsor ID
- SCC_DOC / SCC_DOC
- Conditions
- Disorders of Consciousness
- Keywords
- Disorders of Consciousness, clinical complications
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETSUniversity, hospital or other
- Study start
- 15 May 2024 (actual)
- Primary completion
- 30 Nov 2024 (actual)
- Study completion
- 30 Dec 2024 (actual)
- First posted
- 12 Dec 2023 (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 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).
Detailed description
Validation of a scale for the assessment of clinical complications (Clinical Complications Scale, CCS) on a sample of DoC patients with:
- assessment of inter-rater agreement;
- assessment of concurrent validity with a similar instrument (CoCoS).
This study will be implemented throutgh three phases:
(i) Identification of a group of evaluators at participating centers (n=3 per center; total n=18) and training them to administer the CCS and CoCos scales by group videoconference; (ii) Recruitment of a sample of DoC patients (n=7 per center; total n=42) who will each undergo assessment with CCS (administered twice by two independent assessors, A and B) and with CoCoS (administered by a third independent assessor, C); (iii) Evaluation of the degree of agreement between observers in administering the CCS scale (agreement between evaluators A and B) and evaluation of concurrent validity between CCS and CoCoS scale (agreement between evaluators A/B and C).
The study involves the collection of the following clinical data for each patient on admission and during the following 15 days:
- Demographic data respecting patient anonymity (patient's numeric identification code, age, sex, ethnicity, education);
- Anamnestic data (date and etiology of acute event);
- Clinical data including blood chemistry tests, clinical complications and related therapies administered as per normal clinical reports in use at enrolling units, and referring to the 15-day period following the date of enrollment. Each patient also will be evaluated with CRS-R scale 3-5 times within one week after enrollment for confirmation of the diagnosis of DoC. Assessments with CCS and CoCoS clinical scales completed on clinical reports referring to medical complications that occurred within 15 days of enrollment.
The CCS provides a record of clinical complications in 11 categories corresponding to systems of the body (metabolic abnormalities, disorders-cardiovascular, skin and musculoskeletal problems, gastrointestinal disorders, genito-urinary disorders, respiratory disorders) or categories of clinical problems frequently encountered in the population of patients with DoC (neurosurgical complications, epilepsy and myoclonus, paraosteortropathy, neurovegetative crisis, sepsis; Estraneo et al., 2018). For each category, the severity of complications is graded from 0 (absent complication) to 3 (severe complication) based on the intensity of the therapeutic intervention required, interference with the clinic, and/or frequency and duration of morbid events (an exception is the "sepsis" category for which only presence/absence is recorded). In the case of multiple clinical complications occurring within the same category, the most severe will be considered for the severity score. In this way, a cumulative scale score with range 0-31 can be derived.
Descriptive data from the sample at study entry will be expressed in terms of mean and standard deviation for quantitative variables and as frequencies for nominal variables. For the assessment of inter-rater agreement in the administration of the CCS, Fleiss' weighted K-index will be calculated on the individual subscale scores and the total score of the scale administered to each patient by two different operators. For concurrent validity testing between the CCS and CoCoS scales, Fleiss' weighted K-index will be calculated between the scores at the subscales in common between the two instruments, while Spearman's correlation coefficient for ranks will be calculated on the total scores obtained by patients on the two scales.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 15 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with DoC consecutively admitted to participating units and met the inclusion criteria | – | Other: No intervention, study is observationalPatients 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- Absence of the informed consent by the patient's legal representative.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No intervention, study is observationalNo intervention, study is observational | Other | Patients with DoC consecutively admitted to participating units and met the inclusion criteria |
Primary outcome
inter-rater reliability
Time frame: 15 days from enrolment
agreement in scores between different examiners
concurrent validity
Time frame: 15 days from enrolment
correlation between scores on the CCS and the CoCoS
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2025.
- Background: PubMed 11839831Giacino 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.
- Background: PubMed 28543735Wannez 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.
- Background: PubMed 31681139Pistoia 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.
- Background: PubMed 29807003Estraneo 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.
- 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.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Anna Estraneo, MD principal investigator
Fondazione Don Carlo Gnocchi ETS
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Disorders of Consciousness, run by Fondazione Don Carlo Gnocchi ETS at 6 sites 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 4 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: finished, as of the sponsor's last update on 6 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
inter-rater reliability (time frame: 15 days from enrolment). The study lists 2 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 NCT06167200, which also lists 5 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 6 Feb 2025.