Status:
COMPLETED
Validation of a Clinical Complications Scale (CCS) in Patients With Disorders of Consciousness
Lead Sponsor:
Fondazione Don Carlo Gnocchi Onlus
Conditions:
Disorders of Consciousness
Eligibility:
All Genders
18+ years
Brief 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 ...
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 concurr...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- Absence of the informed consent by the patient's legal representative.
Key Trial Info
Start Date :
May 15 2024
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 30 2024
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT06167200
Start Date
May 15 2024
End Date
December 30 2024
Last Update
February 6 2025
Active Locations (6)
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1
Polo Specialistico Riabilitativo Fondazione Don Carlo Gnocchi ONLUS
Sant'Angelo dei Lombardi, Avellino, Italy, 83054
2
IRCCS Fondazione Don Carlo Gnocchi Firenze
Florence, Italy
3
Polo Riabilitativo del Levante Ligure Fondazione Don Gnocchi
La Spezia, Italy
4
IRCCS S. Maria Nascente Fondazione Don Gnocchi
Milan, Italy