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IMproving diagnosis and PRediction of Outcome in patients with seVEre Disorders Of Consciousness (IMPROVE-DOC)

IMproving diagnosis and PRediction of Outcome in patients with seVEre Disorders Of Consciousness (IMPROVE-DOC) - IMPROVE-DOC

Status
Unknown
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON49174
Enrollment
120
Registered
2019-03-14
Start date
Unknown
Completion date
Unknown
Last updated
2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bewustzijnsstoornissen na ernstig hersenletsel Coma minimally conscious state (MCS) vegetative state/unresponsive wakefulness syndrome (VS/UWS)

Interventions

None listed

Sponsors

Academisch Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. Severe brain injury as a result of: a. Trauma (TBI), or b. Subarachnoid hemorrhage (SAH), or c. Intracranial hemorrhage (ICH), or d. Stroke, or e. Cardiac arrest 2. Severe disorder of consciousness (coma, UWS, or MCS) that: - persist three days after the initial injury, or - three days after discontinuation of sedation 3. Age 18-75 4. Written informed consent from legal representatives

Exclusion criteria

Exclusion criteria: 1. Ongoing neurodegenerative disease

Design outcomes

Primary

MeasureTime frame
The primary outcome of this study is the change over time in behaviour assessed with the coma-recovery scale * revised (CRS-R), EEG*s, and neuroimaging, and the correlation of these changes with the behavioural state (level of consciousness)/GOSE.—

Secondary

MeasureTime frame
-—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)