Prognostic Factors to Regain Consciousness

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-85
SponsorBDH-Klinik Hessisch Oldendorf

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

insufficient cardiorespiratory stability

fractures or severe infratentorial brain injuries leading to impaired auditory evoked - potentials

previous brain damage

mental disorders (dementia, depression)

Trial population

Patients undergoing neurological early rehabilitation with impaired consciousness and admitted to intensive care unit

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Coma-Recovery-Scale-Revised (CRS-R)

    Diagnostic test

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

Treatment groups

130 Participants
are divided into 1 treatment group
Group A: ICU patients1 intervention

Trial outcomes

Primary outcomes

1

Changed functional status

Functional status is measured with Early Rehabilitation Barthel Index (ERBI; Range: -325 to 100; higher scores mean a better outcome) weekly.

Time frame
8 weeks

Secondary outcomes

1

Changed level of consciousness

Level of consciousness is measured with the Coma-Recovery-Scale-Revised (CRS-R; Range: 0 to 23; higher scores mean a better outcome) weekly.

Time frame
8 weeks
2

Duration until consciousness is regained

Time until patients show first signs of consciousness

Time frame
up to 8 weeks

Other outcomes

Sponsors and contacts

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