Actively Recruiting
Prognostic Factors to Regain Consciousness
Led by BDH-Klinik Hessisch Oldendorf · Updated on 2025-09-19
130
Participants Needed
1
Research Sites
391 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Prognostic Factors to Regain Consciousness
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients undergoing early neurological rehabilitation (phase B)
- Diagnosed with stroke, traumatic brain injury, or hypoxic-ischemic encephalopathy
- Having a disorder of consciousness such as coma, unresponsive wakefulness syndrome, or minimally conscious state
- At least two weeks have passed since disease onset
- Admitted to an intensive care unit
- Written consent obtained from the patient's legal representative
- Not pregnant
You will not qualify if you...
- Insufficient cardiorespiratory stability
- Fractures or severe infratentorial brain injuries affecting auditory evoked potentials
- Previous brain damage
- Mental disorders like dementia or depression
- Colonization with multi-resistant pathogens
- Contraindications for MRI
- Claustrophobia
- Weight over 120 kg
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
BDH-Clinic Hessisch Oldendorf
Hessisch Oldendorf, Germany, 31840
Actively Recruiting
Research Team
M
Melanie Boltzmann, PhD
CONTACT
S
Simone B Schmidt, PhD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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