SECONDs' Italian Translation and Transcultural Validation

NCT05714215 | Unknown

• 1 other identifier: IT-SECONDs
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Disorders of Consciousness; Scale; Validation; diagnosis

Outcome Measures

Primary Outcomes (2)

• 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

  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

  21 months

Eligibility Criteria

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

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.

You may qualify if:

• 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

You may not qualify if:

• Appearance of a second brain event

Sponsors & Collaborators

• Fondazione Don Carlo Gnocchi Onlus: lead
• Carlo Besta Neurological Institute: collaborator

Study Sites (1)

IRCCS-don Gnocchi Foundation

Florence, 50143, Italy

RECRUITING

Related Publications (2)

• 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.

  PMID: 32992025 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; Disease

Condition Hierarchy (Ancestors)

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

Study Officials

• Bahia Hakiki, Dr

  IRCCS-Fondazione Don Gnocchi-Florence

  PRINCIPAL INVESTIGATOR

• Bahia Hakiki, Dr

  IRCCS-Fondazione Don Gnocchi-Florence

  STUDY DIRECTOR

Central Study Contacts

Bahia Hakiki, Dr

CONTACT

00393334018388; bhakiki@dongnocchi.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2023
• First Posted: February 6, 2023
• Study Start: October 28, 2021
• Primary Completion: June 15, 2022
• Study Completion: October 31, 2023
• Last Updated: February 21, 2023

Record last verified: 2023-01

Locations

IT (1)