Prognostic Factors to Regain Consciousness

Recruiting now

Conditions studied: Neurologic Disorder, Disorder of Consciousness, Traumatic Brain Injury, Stroke, Hypoxic-Ischemic Encephalopathy

In brief

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.

Key facts

Study ID

NCT04445649

Run by

BDH-Klinik Hessisch Oldendorf

People needed

130

Starts

2020-06-15

Expected to finish

2027-12-15

Last updated by the study team

2025-09-19

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• BDH-Clinic Hessisch Oldendorf — Hessisch Oldendorf, Germany (enrolling)

Full record on ClinicalTrials.gov

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