Neurologic DisorderNCT04445649
Prognostic Factors to Regain Consciousness
An observational study of Neurologic Disorder and Disorder of Consciousness, run by BDH-Klinik Hessisch Oldendorf at 1 site in Germany.
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). Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Neurologic Disorder, Disorder of Consciousness, Traumatic Brain Injury
- What is being tested?
- Coma-Recovery-Scale-Revised (CRS-R)
- How many people
- 130 participants
- Where
- 1 siteGermany
- Study dates
- 15 Jun 2020to 15 Dec 2027
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing neurological early rehabilitation with impaired consciousness and admitted to intensive care unit
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
BDH-Clinic Hessisch Oldendorf
Hessisch Oldendorf, 31840
Melanie Boltzmann, PhD, 0049 5152 781 256, m.boltzmann@bdh-klinik-hessisch-oldendorf.de
About this study
Official title: Investigation of Prognostic Factors to Regain Consciousness in Neurological Early Rehabilitation
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.
Read the detailed 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.
- Conditions
- Neurologic Disorder, Disorder of Consciousness, Traumatic Brain Injury, Stroke, Hypoxic-Ischemic Encephalopathy
- Being tested
- Coma-Recovery-Scale-Revised (CRS-R)
- Keywords
- Neurological rehabilitation, Prognosis, Outcome, Level of consciousness
- Medical subject headings
- Nervous System Diseases, Consciousness Disorders, Brain Injuries, Traumatic, Stroke, Hypoxia-Ischemia, Brain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coma-Recovery-Scale-Revised (CRS-R)Diagnostic test
CRS-R assessments (15 minutes) are repeated weekly after study entry
| Study group | Role | What they receive |
|---|---|---|
| ICU patients | Patients with impaired consciousness admitted to intensive care unit after severe brain injury Receives: Diagnostic Test: Coma-Recovery-Scale-Revised (CRS-R) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changed functional status
Functional status is measured with Early Rehabilitation Barthel Index (ERBI; Range: -325 to 100; higher scores mean a better outcome) weekly.
Measured: 8 weeks
Secondary outcomes (2)
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.
Measured: 8 weeks
Duration until consciousness is regained
Time until patients show first signs of consciousness
Measured: up to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2020
- Study start15 Jun 2020
- Primary completion15 Jun 2027 (estimated)
- Study completion15 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Neurologic DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BDH-Klinik Hessisch Oldendorf
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jens D Rollnik, MD, Study director, BDH-Clinic Hessisch OldendorfMelanie Boltzmann, PhD, Principal investigator, BDH-Clinic Hessisch Oldendorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04445649
- Sponsor's protocol ID
- DOC-OUT
- Status last verified
- Sep 2026
- First submitted
- 18 Jun 2020
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that underlie results in a publication.
Publications
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.
PubMed 30999877Portaccio 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.
PubMed 29428346Portaccio 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.
PubMed 29482376Estraneo 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.
PubMed 23303855Estraneo 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.
PubMed 20554941