Clinical Trial

Prognostic Factors to Regain Consciousness

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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.
Protocol Amendment History 6 amendments
This ClinicalTrials.gov record has been amended 6 times since 2020-06-23; most recent amendment 2025-09-18.
Trial Details
NCT Number NCT04445649
Lead Sponsor BDH-Klinik Hessisch Oldendorf
Conditions Neurologic Disorder, Disorder of Consciousness, Traumatic Brain Injury, Stroke, Hypoxic-Ischemic Encephalopathy
Enrollment 130 participants
Start Date 2020-06-15
Primary Completion 2027-06-15 (estimated)
Study Completion 2027-12-15 (estimated)
Updated on ClinicalTrials.gov 2025-09-19