Actively Recruiting

Age: 18Years - 85Years
All Genders
ID04445649

Investigation of Prognostic Factors to Regain Consciousness in Neurological Early Rehabilitation

Led by BDH-Klinik Hessisch Oldendorf · Updated on 2025-09-19

130

Participants Needed

1

Research Sites

26 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to identify factors that predict medium and long-term recovery outcomes for patients with disorders of consciousness undergoing early neurological rehabilitation. It focuses on patients with severe brain injuries such as stroke, traumatic brain injury, or hypoxic-ischemic encephalopathy, who remain in altered states of consciousness like coma, unresponsive wakefulness syndrome, or minimally conscious state. The study is prospective and observational, enrolling 130 patients over 36 months to better understand the prognosis and treatment options based on detailed patient assessments. Patients admitted to intensive care units after severe brain injury will be observed without any intervention, as this is an observational study. Routine clinical data, disease severity, and functional status will be recorded at study entry. Within the first week, MRI scans, EEGs, and evoked potentials will be measured and then repeated after eight weeks. The level of consciousness will be regularly assessed weekly using the Coma-Recovery-Scale-Revised. Follow-up evaluations with the Glasgow Outcome Scale-Revised will occur at 3, 6, and 12 months to track progress. Participants will undergo weekly assessments of consciousness level, functional status, and monitoring for complications or other health conditions. Researchers will use these measurements to evaluate changes in functional status and consciousness over time, with a focus on outcomes at eight weeks. The study includes detailed imaging and electrophysiological tests to support these evaluations. Total participation may last up to a year with follow-ups to monitor recovery and outcomes, ensuring comprehensive data collection on neurological rehabilitation progress.

CONDITIONS

Brief Title

Prognostic Factors to Regain Consciousness

Who Can Participate

Age: 18Years - 85Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 to 85 years
  • Undergoing early neurological rehabilitation (phase B)
  • Diagnosed with stroke, traumatic brain injury, or hypoxic-ischemic encephalopathy
  • Experiencing a disorder of consciousness (coma, unresponsive wakefulness syndrome, or minimally conscious state)
  • At least two weeks after disease onset
  • Admitted to an intensive care unit
  • Written consent provided by the patient's legal representative
  • Not pregnant
Not Eligible

You will not qualify if you...

  • Insufficient cardiorespiratory stability
  • Fractures or severe infratentorial brain injuries affecting auditory evoked potentials
  • Previous brain damage
  • Mental disorders such as dementia or depression
  • Colonization with multi-resistant pathogens
  • Contraindications for MRI
  • Claustrophobia
  • Weight over 120 kg

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - 1 week

Participants undergo MRI, EEG, and evoked potentials measurements within the first week of early neurological rehabilitation.

1 to 2 visits

Monitoring

Duration - 8 weeks

Participants are monitored weekly with assessments of complications, comorbidities, functional status, and level of consciousness using the Coma-Recovery-Scale-Revised.

Weekly visits for up to 8 weeks

Diagnostic Evaluation

Duration - 1 day

MRI, EEG, and evoked potentials measurements are repeated after 8 weeks to assess changes.

1 visit (in-person)

Long-term Monitoring

Duration - Up to 12 months

Participants are followed up at 3, 6, and 12 months to assess functional status and recovery using the Glasgow Outcome Scale-Revised.

3 visits (in-person)

Trial Site Locations

Total: 1 location

1

BDH-Clinic Hessisch Oldendorf

Hessisch Oldendorf, Germany, 31840

Actively Recruiting

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Research Team

M

Melanie Boltzmann, PhD

S

Simone B Schmidt, PhD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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Published Research Related To This Trial

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.

Emilio Portaccio, Azzurra Morrocchesi, Anna Maria Romoli...

https://pubmed.ncbi.nlm.nih.gov/29428346

Score on Coma Recovery Scale-Revised at admission predicts outcome at discharge in intensive rehabilitation after severe brain injury.

Emilio Portaccio, Azzurra Morrocchesi, Anna Maria Romoli...

https://pubmed.ncbi.nlm.nih.gov/29482376