Investigation of Prognostic Factors to Regain Consciousness in Neurological Early Rehabilitation

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 85
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Germany
BDH-Clinic Hessisch Oldendorf
RECRUITING
Hessisch Oldendorf
Contact Information
Primary
Melanie Boltzmann, PhD
m.boltzmann@bdh-klinik-hessisch.oldendorf
0049 5152 781 256
Backup
Simone B Schmidt, PhD
si.schmidt@bdh-klinik-hessisch.oldendorf
0049 5152 781 215
Time Frame
Start Date: 2020-06-15
Estimated Completion Date: 2027-12-15
Participants
Target number of participants: 130
Treatments
ICU patients
Patients with impaired consciousness admitted to intensive care unit after severe brain injury
Related Therapeutic Areas
Sponsors
Leads: BDH-Klinik Hessisch Oldendorf

This content was sourced from clinicaltrials.gov