Studying Factors That Predict Regaining Consciousness After Brain Injury
Observes adults with disorders of consciousness after brain injury or stroke during early rehabilitation.
Plain-language title generated from the registry record
Registry title: Prognostic Factors to Regain Consciousness
Key facts
- Where
- Hessisch Oldendorf, GermanySee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 85 years old?
Source: NCT04445649, who can take part
Where in Germany
- BDH-Clinic Hessisch OldendorfHessisch Oldendorf, GermanyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- BDH-Klinik Hessisch Oldendorf
- Trial code
- NCT04445649
- Record updated
- 1 October 2026
- Original description
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.Read full original descriptionShow less
Investigation of Prognostic Factors to Regain Consciousness in Neurological Early Rehabilitation
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.
Inclusion: 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; admission to intensive care unit; written consent from the patient's legal representative; exclusion of pregnancy.
Exclusion: previous brain damage; mental disorders (dementia, depression); insufficient cardiorespiratory stability; fractures or severe infratentorial brain injuries leading to impaired auditory evoked - potentials; colonization with multi-resistant pathogens; MRI contraindications; claustrophobia; weight > 120 kg.