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Prognostic Factors to Regain Consciousness

StatusRecruiting
PhaseNot specified
Started
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Record History

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  1. Eligibility criteria expanded, about 15 words
    • Publications: details revised at 5 of 5 entries
  2. Primary completion date: Jun 15, 2025 to Jun 15, 2027
    • Study completion date: Dec 15, 2025 to Dec 15, 2027
    v7
  3. Re-verified, no change to tracked fieldsv6
  4. Primary completion date: Jun 15, 2023 to Jun 15, 2025
    • Study completion date: Dec 15, 2023 to Dec 15, 2025
    v5
  5. 2 versions Re-verified since Jul 20, 2021, no change to tracked fieldsv3-v4
  6. Secondary endpoints: details revised at 1 of 2 entriesv2
  7. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04445649
Lead Sponsor BDH-Klinik Hessisch Oldendorf
Conditions
(from sponsor)		 Neurologic Disorder, Disorder of Consciousness, Traumatic Brain Injury, Stroke, Hypoxic-Ischemic Encephalopathy
Related terms Brain Injuries, Traumatic, Consciousness Disorders, Hypoxia-Ischemia, Brain, Nervous System Diseases, Stroke
Enrollment 130 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov