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Prognostic Factors to Regain Consciousness

NCT04445649 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 130

Last updated 2025-09-19

No results posted yet for this study

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.

Conditions

Interventions

DIAGNOSTIC_TEST

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

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

Sponsors & Collaborators

  • BDH-Klinik Hessisch Oldendorf

    lead OTHER

Principal Investigators

  • Jens D Rollnik, MD · BDH-Clinic Hessisch Oldendorf

  • Melanie Boltzmann, PhD · BDH-Clinic Hessisch Oldendorf

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-15
Primary Completion
2027-06-15
Completion
2027-12-15

Countries

  • Germany

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04445649 on ClinicalTrials.gov