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RecruitingNCT04445649Updated Sep 19, 2025

Prognostic Factors to Regain Consciousness

An observational study in Neurologic Disorder, Disorder of Consciousness and Traumatic Brain Injury, sponsored by BDH-Klinik Hessisch Oldendorf. Recruiting at 1 site in Germany. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2025-09-19.

Sponsored by BDH-Klinik Hessisch Oldendorf · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
130
Ages
18 Years to 85 Years
Sex
All
01

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.

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.

02

Conditions studied

  • Neurologic Disorder
  • Disorder of Consciousness
  • Traumatic Brain Injury
  • Stroke
  • Hypoxic-Ischemic Encephalopathy

Keywords

  • Neurological rehabilitation
  • Prognosis
  • Outcome
  • Level of consciousness
03

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Patients undergoing neurological early rehabilitation with impaired consciousness and admitted to intensive care unit

Eligibility criteria

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
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
130 participants (estimated)
Patient registry
No

Groups and cohorts

  • ICU patients

    Patients with impaired consciousness admitted to intensive care unit after severe brain injury

    Diagnostic Test: Coma-Recovery-Scale-Revised (CRS-R)

Interventions

  • Diagnostic testComa-Recovery-Scale-Revised (CRS-R)

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

05

What researchers measure

Primary outcomes

  1. Changed functional status

    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

Secondary outcomes

  1. 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.

    Time frame: 8 weeks

  2. Duration until consciousness is regained

    Time until patients show first signs of consciousness

    Time frame: up to 8 weeks

06

Study locations

1 of 1 sites recruiting
07

References and documents

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 30999877 ↗
  • 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. PubMed 29428346 ↗
  • 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. PubMed 29482376 ↗
  • 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. PubMed 23303855 ↗
  • 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. PubMed 20554941 ↗

Individual participant data

Plan to share: Yes — All IPD that underlie results in a publication.

Supporting information: Study protocol, Sap, Icf

08

Registry details

Key details

Study ID
NCT04445649
Lead sponsor
BDH-Klinik Hessisch Oldendorf
Responsible party
Sponsor
First posted
Jun 24, 2020
Start date
Jun 15, 2020
Primary completion
Jun 15, 2027 (estimated)
Completion
Dec 15, 2027 (estimated)
Last update
Sep 19, 2025

Study contacts

Melanie Boltzmann, PhD
Contact
m.boltzmann@bdh-klinik-hessisch.oldendorf
0049 5152 781 256
Simone B Schmidt, PhD
Contact
si.schmidt@bdh-klinik-hessisch.oldendorf
0049 5152 781 215
Jens D Rollnik, MD
study director · BDH-Clinic Hessisch Oldendorf
Melanie Boltzmann, PhD
principal investigator · BDH-Clinic Hessisch Oldendorf

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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