IMproving diagnosis and PRediction of Outcome in patients with seVEre Disorders Of Consciousness (IMPROVE-DOC)
Withdrawn
- Conditions
- Bewustzijnsstoornissen na ernstig hersenletselComaminimally conscious state (MCS)vegetative state/unresponsive wakefulness syndrome (VS/UWS)10042258
- Registration Number
- NL-OMON49174
- Lead Sponsor
- Academisch Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- Not specified
- Target Recruitment
- 120
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
1. Ongoing neurodegenerative disease
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary outcome of this study is the change over time in behaviour assessed<br /><br>with the coma-recovery scale * revised (CRS-R), EEG*s, and neuroimaging, and<br /><br>the correlation of these changes with the behavioural state (level of<br /><br>consciousness)/GOSE. </p><br>
- Secondary Outcome Measures
Name Time Method <p>-</p><br>