RecruitingNCT04445649

Prognostic Factors to Regain Consciousness

Investigation of Prognostic Factors to Regain Consciousness in Neurological Early Rehabilitation


Sponsor

BDH-Klinik Hessisch Oldendorf

Enrollment

130 participants

Start Date

Jun 15, 2020

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 85 Years

Inclusion Criteria7

  • 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 Criteria8

  • 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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Interventions

DIAGNOSTIC_TESTComa-Recovery-Scale-Revised (CRS-R)

CRS-R assessments (15 minutes) are repeated weekly after study entry


Locations(1)

BDH-Clinic Hessisch Oldendorf

Hessisch Oldendorf, Germany

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NCT04445649


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