Status:

RECRUITING

Prognostic Factors to Regain Consciousness

Lead Sponsor:

BDH-Klinik Hessisch Oldendorf

Conditions:

Neurologic Disorder

Disorder of Consciousness

Eligibility:

All Genders

18-85 years

Brief 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, o...

Detailed Description

Due to continuous improvements in acute medical care, the number of patients surviving severe brain damage has increased over the past decades. While some patients improve significantly during the fir...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

June 15 2020

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

December 15 2027

Estimated Enrollment :

130 Patients enrolled

Trial Details

Trial ID

NCT04445649

Start Date

June 15 2020

End Date

December 15 2027

Last Update

September 19 2025

Active Locations (1)

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BDH-Clinic Hessisch Oldendorf

Hessisch Oldendorf, Germany, 31840