CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 42 enrolled
Drug / intervention
No intervention, study is observationalother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06167200
NCT06167200N/ACompleted

Validation of a Clinical Complications Scale (CCS) in Patients With Disorders of Consciousness

Fondazione Don Carlo Gnocchi Onlus·observational·Posted Dec 12, 2023·Updated Feb 6, 2025

In Brief

An observational study evaluating No intervention, study is observational for Disorders of Consciousness. Completed, enrolled 42 participants across 6 sites.

Detailed 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 developing clinical complications. In this study, the investigators propose a new Clinical Complications Scale (CCS) developed to assess the impact of clinical complications on the long-term evolution of a cohort of patients with DoC. This is a multi-site prospective observational study conducted in patients with Severe Acquired Brain Injury and DoC admitted to six centers of Fondazione Don Gnocchi (Italy), with clinical data collection not deviating from routine practice (except for CCS administration). The study is non-commercial and will have a maximum total duration of 24 months. It is planned to assess inter-rater agreement and concurrent validity with a similar instrument (CoCoS scale).

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesItaly
Collaborators--

Timeline

N/ACompletedFinished
202420252026
First PostedDec 12, 2023
Enrollment StartMay 15, 2024
Primary CompletionNov 30, 2024
Study CompletionDec 30, 2024
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 2.6 years ago

Interventions

No intervention, study is observationalother

No intervention, study is observational