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RECRUITING
NCT04445649

Prognostic Factors to Regain Consciousness

Sponsor: BDH-Klinik Hessisch Oldendorf

View on ClinicalTrials.gov

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.

Official title: Investigation of Prognostic Factors to Regain Consciousness in Neurological Early Rehabilitation

Key Details

Gender

All

Age Range

18 Years - 85 Years

Study Type

OBSERVATIONAL

Enrollment

130

Start Date

2020-06-15

Completion Date

2027-12-15

Last Updated

2025-09-19

Healthy Volunteers

No

Interventions

DIAGNOSTIC_TEST

Coma-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