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SECONDs' Italian Translation and Transcultural Validation

NCT05714215 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 60

Last updated 2023-02-21

No results posted yet for this study

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. 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

Conditions

  • Disorder of Consciousness

Sponsors & Collaborators

  • Carlo Besta Neurological Institute

    collaborator OTHER

  • Fondazione Don Carlo Gnocchi Onlus

    lead OTHER

Principal Investigators

  • Bahia Hakiki, Dr · IRCCS-Fondazione Don Gnocchi-Florence

  • Bahia Hakiki, Dr · IRCCS-Fondazione Don Gnocchi-Florence

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-28
Primary Completion
2022-06-15
Completion
2023-10-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05714215 on ClinicalTrials.gov