Prognostic Factors to Regain Consciousness

Stroke Clinical Trial

Official title:

Investigation of Prognostic Factors to Regain Consciousness in Neurological Early Rehabilitation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04445649
• Other study ID #: DOC-OUT
• Status: Recruiting
• Start date: June 15, 2020
• Est. completion date: December 15, 2025

Study information

• Verified date: August 2023
• Source: BDH-Klinik Hessisch Oldendorf
• Contact: Melanie Boltzmann, PhD
• Phone: 0049 5152 781 256
• Email: m.boltzmann[@]bdh-klinik-hessisch.oldendorf
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 130
• Est. completion date: December 15, 2025
• Est. primary completion date: June 15, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• insufficient cardiorespiratory stability
• fractures or severe infratentorial brain injuries leading to impaired auditory evoked
• potentials
• previous brain damage
• mental disorders (dementia, depression)
• colonization with multi-resistant pathogens
• MRI contraindications
• claustrophobia
• weight > 120 kg

Related Conditions & MeSH terms

• Brain Diseases
• Brain Injuries
• Brain Injuries, Traumatic
• Brain Ischemia
• Consciousness Disorders
• Disorder of Consciousness
• Hypoxia-Ischemia, Brain
• Hypoxic-Ischemic Encephalopathy
• Nervous System Diseases
• Neurologic Disorder
• Stroke
• Traumatic Brain Injury

Intervention

Diagnostic Test:
• Coma-Recovery-Scale-Revised (CRS-R)
CRS-R assessments (15 minutes) are repeated weekly after study entry

Locations

Country	Name	City	State
Germany	BDH-Clinic Hessisch Oldendorf	Hessisch Oldendorf

Sponsors (1)

Lead Sponsor	Collaborator
BDH-Klinik Hessisch Oldendorf

Country where clinical trial is conducted

Germany, 

References & Publications (5)

Estraneo A, Moretta P, Loreto V, Lanzillo B, Cozzolino A, Saltalamacchia A, Lullo F, Santoro L, Trojano L. Predictors of recovery of responsiveness in prolonged anoxic vegetative state. Neurology. 2013 Jan 29;80(5):464-70. doi: 10.1212/WNL.0b013e31827f0f31. Epub 2013 Jan 9. — View Citation

Estraneo A, Moretta P, Loreto V, Lanzillo B, Santoro L, Trojano L. Late recovery after traumatic, anoxic, or hemorrhagic long-lasting vegetative state. Neurology. 2010 Jul 20;75(3):239-45. doi: 10.1212/WNL.0b013e3181e8e8cc. Epub 2010 Jun 16. — View Citation

Lucca LF, Lofaro D, Pignolo L, Leto E, Ursino M, Cortese MD, Conforti D, Tonin P, Cerasa A. Outcome prediction in disorders of consciousness: the role of coma recovery scale revised. BMC Neurol. 2019 Apr 18;19(1):68. doi: 10.1186/s12883-019-1293-7. — View Citation

Portaccio E, Morrocchesi A, Romoli AM, Hakiki B, Taglioli MP, Lippi E, Di Renzone M, Grippo A, Macchi C. Score on Coma Recovery Scale-Revised at admission predicts outcome at discharge in intensive rehabilitation after severe brain injury. Brain Inj. 2018;32(6):730-734. doi: 10.1080/02699052.2018.1440420. Epub 2018 Feb 26. — View Citation

Portaccio E, Morrocchesi A, Romoli AM, Hakiki B, Taglioli MP, Lippi E, Di Renzone M, Grippo A, Macchi C; Intensive Rehabilitation Unit Study Group of the IRCCS Don Gnocchi Foundation, Italy. Improvement on the Coma Recovery Scale-Revised During the First Four Weeks of Hospital Stay Predicts Outcome at Discharge in Intensive Rehabilitation After Severe Brain Injury. Arch Phys Med Rehabil. 2018 May;99(5):914-919. doi: 10.1016/j.apmr.2018.01.015. Epub 2018 Feb 8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changed functional status	Functional status is measured with Early Rehabilitation Barthel Index (ERBI; Range: -325 to 100; higher scores mean a better outcome) weekly.	8 weeks
Secondary	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.	8 weeks
Secondary	Duration until consciousness is regained	Time until patients show first signs of consciousness	up to 8 weeks