About this trial
The study aims to identify factors that predict the medium and long-term outcome of patients with disorders of consciousness (DOC) undergoing early neurological rehabilitation.
In this prospective, observational study, 130 DOC patients are going to be included (36 months). At study entry, different routine data, disease severity and functional status are documented for each patient. In addition, MRI, EEG and evoked potentials are measured within the first week. The level of consciousness is recorded with the Coma-Recovery-Scale-Revised and serves as the primary outcome parameter. Complications, comorbidities, functional status and leve of consciousness are assessed weekly. After eight weeks, the measurement of the MRI, the EEG and the evoked potentials are repeated. After 3, 6 and 12 months, the Glasgow Outcome Scale-Revised is used to followed up the current status of the patients.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
early neurological rehabilitation (phase B)
stroke, traumatic brain injury, hypoxic-ischemic encephalopathy
disorder of consciousness (coma, UWS, MCS)
at minimum two weeks after disease onset
Disqualifiers
insufficient cardiorespiratory stability
fractures or severe infratentorial brain injuries leading to impaired auditory evoked - potentials
previous brain damage
mental disorders (dementia, depression)
Trial population
Patients undergoing neurological early rehabilitation with impaired consciousness and admitted to intensive care unit
Trial design
Cohort
Prospective
Treatments tested in this trial
Coma-Recovery-Scale-Revised (CRS-R)
Diagnostic testCRS-R assessments (15 minutes) are repeated weekly after study entry
Treatment groups
Trial outcomes
Primary outcomes
Changed functional status
Functional status is measured with Early Rehabilitation Barthel Index (ERBI; Range: -325 to 100; higher scores mean a better outcome) weekly.
Secondary outcomes
Changed level of consciousness
Level of consciousness is measured with the Coma-Recovery-Scale-Revised (CRS-R; Range: 0 to 23; higher scores mean a better outcome) weekly.
Duration until consciousness is regained
Time until patients show first signs of consciousness
Sponsors and contacts
Click on the lead sponsor to view all of their trials.