Outcome prediction in disorders of consciousness: the role of coma recovery scale revised.
Lucia Francesca Lucca, Danilo Lofaro, Loris Pignolo...
https://pubmed.ncbi.nlm.nih.gov/30999877Actively Recruiting
Led by BDH-Klinik Hessisch Oldendorf · Updated on 2025-09-19
130
Participants Needed
1
Research Sites
26 weeks
Total Duration
This research aims to identify factors that predict medium and long-term recovery outcomes for patients with disorders of consciousness undergoing early neurological rehabilitation. It focuses on patients with severe brain injuries such as stroke, traumatic brain injury, or hypoxic-ischemic encephalopathy, who remain in altered states of consciousness like coma, unresponsive wakefulness syndrome, or minimally conscious state. The study is prospective and observational, enrolling 130 patients over 36 months to better understand the prognosis and treatment options based on detailed patient assessments. Patients admitted to intensive care units after severe brain injury will be observed without any intervention, as this is an observational study. Routine clinical data, disease severity, and functional status will be recorded at study entry. Within the first week, MRI scans, EEGs, and evoked potentials will be measured and then repeated after eight weeks. The level of consciousness will be regularly assessed weekly using the Coma-Recovery-Scale-Revised. Follow-up evaluations with the Glasgow Outcome Scale-Revised will occur at 3, 6, and 12 months to track progress. Participants will undergo weekly assessments of consciousness level, functional status, and monitoring for complications or other health conditions. Researchers will use these measurements to evaluate changes in functional status and consciousness over time, with a focus on outcomes at eight weeks. The study includes detailed imaging and electrophysiological tests to support these evaluations. Total participation may last up to a year with follow-ups to monitor recovery and outcomes, ensuring comprehensive data collection on neurological rehabilitation progress.
CONDITIONS
Prognostic Factors to Regain Consciousness
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You will not qualify if you...
Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 week
Participants undergo MRI, EEG, and evoked potentials measurements within the first week of early neurological rehabilitation.
1 to 2 visits
Duration - 8 weeks
Participants are monitored weekly with assessments of complications, comorbidities, functional status, and level of consciousness using the Coma-Recovery-Scale-Revised.
Weekly visits for up to 8 weeks
Duration - 1 day
MRI, EEG, and evoked potentials measurements are repeated after 8 weeks to assess changes.
1 visit (in-person)
Duration - Up to 12 months
Participants are followed up at 3, 6, and 12 months to assess functional status and recovery using the Glasgow Outcome Scale-Revised.
3 visits (in-person)
Total: 1 location
1
BDH-Clinic Hessisch Oldendorf
Hessisch Oldendorf, Germany, 31840
Actively Recruiting
M
Melanie Boltzmann, PhD
S
Simone B Schmidt, PhD
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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