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Prognostic Factors to Regain Consciousness

Recruitingn/aAges 18 Years - 85 YearsAllBDH-Klinik Hessisch Oldendorf
NCT04445649 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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 Criteria: * insufficient cardiorespiratory stability * fractures or severe infratentorial brain injuries leading to impaired auditory evoked - potentials * previous brain damage * mental disorders (dementia, depression) * colonization with multi-resistant pathogens * MRI contraindications * claustrophobia * weight \> 120 kg
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What it tests

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

1 site
BDH-Clinic Hessisch Oldendorf
Hessisch Oldendorf, Germany
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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