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NCT06167200: SCC_DOC
Validation of a Clinical Complications Scale (CCS) in Patients With Disorders of Consciousness
trial testing No intervention, study is observational in Disorders of Consciousness in 42 participants. Completed in 30 December 2024.
30 November 2024
Quick facts
| Lead sponsor | Fondazione Don Carlo Gnocchi Onlus |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 42 |
| Start date | 15 May 2024 |
| Primary completion | 30 November 2024 |
| Estimated completion | 30 December 2024 |
| Sites | 6 locations across Italy |
Drugs / interventions tested
- No intervention, study is observational
Conditions studied
- Disorders of Consciousness — all drugs for Disorders of Consciousness →
Sponsor
Fondazione Don Carlo Gnocchi Onlus — full company profile →
Who can join
18 and older, any sex, with Disorders of Consciousness. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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).
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
The clinical complication scale of Fondazione Don Gnocchi for classifying clinical complications in patients with severe acquired brain injury: development and multicenter validation.
Estraneo A, Fiorentino MR, Cibellis T, Campana B, et al · · 2025 · cited 1× · PMID 40144623 · DOI 10.3389/fneur.2025.1537093
Verify or expand the search:
- PubMed search for NCT06167200
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Disorders of Consciousness
Currently open trials in the same condition.
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Other Fondazione Don Carlo Gnocchi Onlus trials
Trials by the same sponsor.
- NCT07252856 — Transcultural Digital Solutions in Phase III Cardiac Rehabilitation · NA · not yet recruiting
- NCT07290218 — Tridimensional Robotic Assessment of Neglect in Brain Injured Patients · not yet recruiting
- NCT07064226 — Validation of a Digital Intervention to Rehabilitate Cognitive Resources · NA · recruiting
- NCT07130929 — Functional Electrical Stimulation to Treat Critical Neuromyopathy After Severe Stroke: a Pilot Study. · NA · recruiting
- NCT07159854 — Telerehabilitation in Central and Peripheral Neurological Sequelae From Chemotherapy · NA · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06167200 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Fondazione Don Carlo Gnocchi Onlus
- Last refreshed: 6 February 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06167200.
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