Disorder of ConsciousnessIT-SECONDsNCT05714215
SECONDs' Italian Translation and Transcultural Validation
An observational study of Disorder of Consciousness, run by Fondazione Don Carlo Gnocchi ETS at 1 site in Italy.
Trial summary
The coma recovery scale-revised (CRS-R) is the recommended diagnostic scale for consciousness but it requires time, training, and provides total scores that do not always reflect the correct level of consciousness. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Disorder of Consciousness
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- 28 Oct 2021to 31 Oct 2023
- 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: For the pilot intra and inter-rater validation study (Phase 2A), the enrollment of 10 consecutive patients (5 Florence, 2 Sant'Angelo and 3 Besta) is envisaged, subject to the signature of the informed consent of the legal representative. For the second phase of multicentre validation, the recruitment of 60 consecutive or distributed patients is foreseen, Florence: 28; Sant'Angelo: 10 and Istituto Besta: 22.
Who may be able to join
- Diagnosis of severe acquired brain injury
- Diagnosis of a disorder of consciousness
- •> 28 days from the acute event
- age> 18 years
- No history of neurological or psychiatric deficits
- Mother tongue: Italian
- Clinical stability (eg, absence of mechanical ventilation, sedation, infection, ensuing seizures).
- Signature of the informed consent by the legal representative
Who cannot join
- Appearance of a second brain event
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
IRCCS-don Gnocchi Foundation
Florence, 50143
Chiara Fanciullacci, Dr., 00390557393653, cfanciullacci@dongnocchi.it
About this study
Official title: Italian Translation and Transcultural Validation of the Simplified Evaluation of Consciousness Disorders (SECONDs) Scale: a Multicentre Study
The coma recovery scale-revised (CRS-R) is the recommended diagnostic scale for consciousness but it requires time, training, and provides total scores that do not always reflect the correct level of consciousness. Recently, a new short-term assessment tool for consciousness assessment has been validated, which could easily be implemented in daily practice to determine the level of consciousness in severely brain injured individuals: the simplified evaluation of consciousness disorders (SECONDs) .Its administration should be significantly shorter than CRS-R and accurate to allow monitoring of consciousness in the subacute / chronic phase. The SECONDs scale was constructed by selecting the items that, based on the latest scientific evidence, are most frequently associated with a minimally consciousness state. In fact, recent studies have shown that 5 items of the CRS-R allow to identify 99% of individuals with minimally consciousness state 1) reproducible movement on command, 2) visual pursuit 3) visual fixation 4) automatic motor response, and 5) localization to pain) 12. In addition, some changes have been introduced such as 1) the assessment of fixation and visual tracking through the use of the mirror 2) the use of autobiographical questions for the assessment of communication 3) the reduction of the number of orders on command to 2 of 3 instead of 3 out of 4 as in the CRS-R. All these changes have been made to minimize time for administration without compromising the accuracy of consciousness detection, to improve feasibility in clinical practice, and also to limit fatigue, which could produce better patient concentration and collaboration.
The aim of the multicentre study is to carry out a cross-cultural translation of the SECONDs assessment scale into Italian and to perform a validation between operators of different professions of the Italian version. validation will be conducted on a group of patients with prolunged disorders of consciousness in the subacute phase admitted to two units of severe acquired brain injuries of the don Carlo Gnocchi Foundation of Florence and Sant'Angelo dei Lombardi, and in the chronic phase IRCCS foundation Carlo Besta neurological institute
Read the detailed description
The first phase involves the Italian translation of the SECONDs scale through a rigorous multi-stage review and the drafting of the working and final versions. First, the original scale will undergo a forward translation into Italian by a certified translator. The Italian version obtained will then be discussed by the team of experts from the 3 centers participating in the study for transcultural adaptation. Then the revised Italian version will be subsequently back translated into the original language by another certified translator blinded from the original version. Any discrepancy will be thoroughly discussed between the interdisciplinary Italian group and with the external expert from the group that originally developed the scale, and the Italian version shall be re-defined, with the aim of determining the conceptual, semantic, and operational equivalence of the translated scale. (Phase 1) The second phase involves a pilot study in which the final Italian version of the identified scale will be administered to a small group of patients to determine its intra and interoperative validity (Phase 2A) Subsequently, the multicentre validation of the Italian scale is envisaged on a larger group of patients, 38 admitted to inpatient intensive rehabilitation in the subacute phase (don Gnocchi foundation) and 22 admitted to outpatient rehabilitation in the chronic phase (Istituto Besta) (Phase 2B).
- Conditions
- Disorder of Consciousness
- Keywords
- Disorders of Consciousness, Scale, Validation, diagnosis
- Medical subject headings
- Consciousness Disorders, Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
The concurrent validity of the transcultural adaptation of the SECONDs scale with the CRS-R (correlation coefficient for Spearman's ranks)
The endpoint of the study is the creation of a valid and reliable transcultural adaptation of the SECONDs scale
Measured: 21 months
the indexes of agreement between inter and intra examiners (index K)
The endpoint of the study is the creation of a valid and reliable transcultural adaptation of the SECONDs scale
Measured: 21 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2023
- Study start28 Oct 2021
- Primary completion15 Jun 2022
- Study completion31 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Disorder 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
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETS
- Sponsor type
- University, hospital or other
- Collaborators
- Carlo Besta Neurological Institute
- Responsible party
- Sponsor
- Investigators
- Bahia Hakiki, Dr, Principal investigator, IRCCS-Fondazione Don Gnocchi-FlorenceBahia Hakiki, Dr, Study director, IRCCS-Fondazione Don Gnocchi-Florence
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05714215
- Sponsor's protocol ID
- IT-SECONDs
- Acronym
- IT-SECONDs
- Status last verified
- Jan 2023
- First submitted
- 19 Jan 2023
- Last updated
- 21 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Aubinet C, Cassol H, Bodart O, Sanz LRD, Wannez S, Martial C, Thibaut A, Martens G, Carriere M, Gosseries O, Laureys S, Chatelle C. Simplified evaluation of CONsciousness disorders (SECONDs) in individuals with severe brain injury: A validation study. Ann Phys Rehabil Med. 2021 Sep;64(5):101432. doi: 10.1016/j.rehab.2020.09.001. Epub 2021 Jul 28.
PubMed 32992025Giacino 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 21 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Italian Translation and Transcultural Validation of the Simplified Evaluation of Consciousness Disorders (SECONDs) Scale: a Multicentre Study
- ClinicalTrials.gov ID
- NCT05714215
- Acronym / sponsor ID
- IT-SECONDs / IT-SECONDs
- Conditions
- Disorder of Consciousness
- Keywords
- Disorders of Consciousness, Scale, Validation, diagnosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETSUniversity, hospital or other
- Collaborators
- Carlo Besta Neurological Institute
- Study start
- 28 Oct 2021 (actual)
- Primary completion
- 15 Jun 2022 (actual)
- Study completion
- 31 Oct 2023 (estimated)
- First posted
- 6 Feb 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 coma recovery scale-revised (CRS-R) is the recommended diagnostic scale for consciousness but it requires time, training, and provides total scores that do not always reflect the correct level of consciousness. Recently, a new short-term assessment tool for consciousness assessment has been validated, which could easily be implemented in daily practice to determine the level of consciousness in severely brain injured individuals: the simplified evaluation of consciousness disorders (SECONDs) .Its administration should be significantly shorter than CRS-R and accurate to allow monitoring of consciousness in the subacute / chronic phase. The SECONDs scale was constructed by selecting the items that, based on the latest scientific evidence, are most frequently associated with a minimally consciousness state. In fact, recent studies have shown that 5 items of the CRS-R allow to identify 99% of individuals with minimally consciousness state 1) reproducible movement on command, 2) visual pursuit 3) visual fixation 4) automatic motor response, and 5) localization to pain) 12. In addition, some changes have been introduced such as 1) the assessment of fixation and visual tracking through the use of the mirror 2) the use of autobiographical questions for the assessment of communication 3) the reduction of the number of orders on command to 2 of 3 instead of 3 out of 4 as in the CRS-R. All these changes have been made to minimize time for administration without compromising the accuracy of consciousness detection, to improve feasibility in clinical practice, and also to limit fatigue, which could produce better patient concentration and collaboration.
The aim of the multicentre study is to carry out a cross-cultural translation of the SECONDs assessment scale into Italian and to perform a validation between operators of different professions of the Italian version. validation will be conducted on a group of patients with prolunged disorders of consciousness in the subacute phase admitted to two units of severe acquired brain injuries of the don Carlo Gnocchi Foundation of Florence and Sant'Angelo dei Lombardi, and in the chronic phase IRCCS foundation Carlo Besta neurological institute
Detailed description
The first phase involves the Italian translation of the SECONDs scale through a rigorous multi-stage review and the drafting of the working and final versions. First, the original scale will undergo a forward translation into Italian by a certified translator. The Italian version obtained will then be discussed by the team of experts from the 3 centers participating in the study for transcultural adaptation. Then the revised Italian version will be subsequently back translated into the original language by another certified translator blinded from the original version. Any discrepancy will be thoroughly discussed between the interdisciplinary Italian group and with the external expert from the group that originally developed the scale, and the Italian version shall be re-defined, with the aim of determining the conceptual, semantic, and operational equivalence of the translated scale. (Phase 1) The second phase involves a pilot study in which the final Italian version of the identified scale will be administered to a small group of patients to determine its intra and interoperative validity (Phase 2A) Subsequently, the multicentre validation of the Italian scale is envisaged on a larger group of patients, 38 admitted to inpatient intensive rehabilitation in the subacute phase (don Gnocchi foundation) and 22 admitted to outpatient rehabilitation in the chronic phase (Istituto Besta) (Phase 2B).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- For the pilot intra and inter-rater validation study (Phase 2A), the enrollment of 10 consecutive patients (5 Florence, 2 Sant'Angelo and 3 Besta) is envisaged, subject to the signature of the informed consent of the legal representative. For the second phase of multicentre validation, the recruitment of 60 consecutive or distributed patients is foreseen, Florence: 28; Sant'Angelo: 10 and Istituto Besta: 22.
Key inclusion criteria (8 listed)
- Diagnosis of severe acquired brain injury
- Diagnosis of a disorder of consciousness
- •> 28 days from the acute event
- age> 18 years
- No history of neurological or psychiatric deficits
Key exclusion criteria (1 listed)
- Appearance of a second brain event
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
The concurrent validity of the transcultural adaptation of the SECONDs scale with the CRS-R (correlation coefficient for Spearman's ranks)
Time frame: 21 months
The endpoint of the study is the creation of a valid and reliable transcultural adaptation of the SECONDs scale
the indexes of agreement between inter and intra examiners (index K)
Time frame: 21 months
The endpoint of the study is the creation of a valid and reliable transcultural adaptation of the SECONDs scale
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2023.
- Background: PubMed 32992025Aubinet C, Cassol H, Bodart O, Sanz LRD, Wannez S, Martial C, Thibaut A, Martens G, Carriere M, Gosseries O, Laureys S, Chatelle C. Simplified evaluation of CONsciousness disorders (SECONDs) in individuals with severe brain injury: A validation study. Ann Phys Rehabil Med. 2021 Sep;64(5):101432. doi: 10.1016/j.rehab.2020.09.001. Epub 2021 Jul 28.
- 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: Undecided
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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.
Bahia Hakiki, Dr principal investigator
IRCCS-Fondazione Don Gnocchi-Florence
Bahia Hakiki, Dr study director
IRCCS-Fondazione Don Gnocchi-Florence
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 Disorder of Consciousness, run by Fondazione Don Carlo Gnocchi ETS 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 8 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: status not confirmed, as of the sponsor's last update on 21 Feb 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bahia Hakiki, Dr (00393334018388, bhakiki@dongnocchi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The concurrent validity of the transcultural adaptation of the SECONDs scale with the CRS-R (correlation coefficient for Spearman's ranks) (time frame: 21 months). 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 NCT05714215, which also lists 2 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 21 Feb 2023.