BDH-Clinic Hessisch Oldendorf
Hessisch Oldendorf, 31840, Germany
Location status: Recruiting
NCT Number: NCT04445649
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.
Interested in participating?
Request Info18 year–85 year
All sexes
Observational
Hessisch Oldendorf, 31840, Germany
Location status: Recruiting
Due to continuous improvements in acute medical care, the number of patients surviving severe brain damage has increased over the past decades. While some patients improve significantly during the first days after the injury, other patients remain in altered states of consciousness (i.e. coma, unresponsive wakefulness syndrome or minimally conscious state). Acquired brain damage such as cerebrovascular diseases, traumatic brain injuries or hypoxic-ischemic encephalopathies are the main causes of severe impaired consciousness.The correct classification of the level of consciousness is of great importance, since the different states of consciousness are associated with different prognoses and treatment options. Patients who show minimal signs of consciousness (MCS) a month after the onset of the disease have better chances of regaining consciousness within one year than UWS patients. Within both categories (UWS, MCS), traumatic aetiologies in turn have a better prognosis than non-traumatic aetiologies. The prognosis usually begins with the admission of the patients to the intensive care unit of the acute care facility. But even in later treatment phases, a large number of patients regain consciousness, e.g. during post-acute early rehabilitation and even years after the disease. Numerous factors are associated with the prognosis (e.g. age, aetiology, duration of illness, functional status and state of consciousness). Although there are numerous studies on the prognostic factors and outcome of patients with severe brain damage, only a few have explicitly examined patients with initially severe and long-lasting impaired consciousness. The study therefore aims to identify factors that predict the medium and long-term outcome of patients with severe impaired consciousness in early neurological rehabilitation.
Over a period of 36 months, 130 patients undergoing neurological early rehabilitation with impaired consciousness are included. It is a prospective observational study that is carried out in a single neurological rehabilitation centre (monocentric). 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 follow up the current status of the patients.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
CRS-R assessments (15 minutes) are repeated weekly after study entry
Time frame: 8 weeks
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
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: up to 8 weeks
Time until patients show first signs of consciousness
Contact information is provided by the study sponsor or research team.
Melanie Boltzmann, PhD
CONTACT
Simone B Schmidt, PhD
CONTACT
BDH-Klinik Hessisch Oldendorf
Other
Investigation of Prognostic Factors to Regain Consciousness in Neurological Early Rehabilitation
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT04442971
Brain Diseases, Brain Injuries
Hessisch Oldendorf, Germany
View Trial DetailsNCT04930822
Acquired Brain Injury, Blindness
Wallingford, Connecticut, United States
View Trial DetailsNCT04564495
Autoimmune Diseases, Autoimmune Diseases of the Nervous System
White Plains, New York, United States
View Trial DetailsNCT06617377
Cardiac Arrest, Cardiovascular Diseases
Toulouse, France
View Trial Details