Prognostic Factors to Regain Consciousness

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-85
SponsorBDH-Klinik Hessisch Oldendorf

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

Qualifiers

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 design

Treatments tested in this trial

  • Coma-Recovery-Scale-Revised (CRS-R)

Treatment groups

130 Participants
are divided into 1 treatment group

Sponsors and collaborators