Prognostic Factors to Regain Consciousness

Condition(s) studied

Investigational drug(s) / intervention(s)

Coma-Recovery-Scale-Revised (CRS-R): CRS-R assessments (15 minutes) are repeated weekly after study entry

Study summary

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

Primary outcome measure(s)

• Changed functional status — 8 weeks
  Functional status is measured with Early Rehabilitation Barthel Index (ERBI; Range: -325 to 100; higher scores mean a better outcome) weekly.

Trial sites (1)

More BDH-Klinik Hessisch Oldendorf trials in Germany

Other trials for the same condition