NCT05714215: IT-SECONDs

SECONDs' Italian Translation and Transcultural Validation

Status unknown Last updated 21 February 2023

What this trial tests

trial in Disorder of Consciousness in 60 participants. Status unknown.

Timeline

28 October 2021

Primary endpoint
15 June 2022

31 October 2023

Quick facts

Lead sponsor	Fondazione Don Carlo Gnocchi Onlus
Status	Status unknown
Study type	OBSERVATIONAL
Enrollment	60
Start date	28 October 2021
Primary completion	15 June 2022
Estimated completion	31 October 2023
Sites	1 location across Italy

Conditions studied

• Disorder of Consciousness — all drugs for Disorder of Consciousness →

Sponsor

Fondazione Don Carlo Gnocchi Onlus — full company profile →

Who can join

18 and older, any sex, with Disorder of Consciousness. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Cross-cultural adaptation and multicentric validation of the Italian version of the Simplified Evaluation of CONsciousness Disorders (SECONDs).
   Hakiki B, Pancani S, De Nisco A, Romoli AM, et al · · 2025 · cited 1× · PMID 39928598 · DOI 10.1371/journal.pone.0317626