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CONNECT-ME: Consciousness in Neurocritical Care Cohort Study Using fMRI and EEG

NCT02644265 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2023-11-15

No results posted yet for this study

Summary

Detecting preserved consciousness in brain-injured patients by traditional clinical means requires presence of motor function. Otherwise, patients may be erroneously classified as being in a vegetative state. In order to circumvent the need for motor function, paradigms using functional magnetic resonance imaging (fMRI) and electroencephalography (EEG) have been developed. According to a recent meta-analysis, 15% of patients with a clinical diagnosis of vegetative state can follow commands by performing mental imaginary tasks, strongly suggesting they are indeed conscious. This is of utmost importance for prognosis, treatment, and resource allocation. However, consciousness paradigms are usually employed in rehabilitation medicine. Therefore, opportunities to optimize patient outcome at an early stage may be lost. As a novel approach, the CONsciousness in NEurocritical Care cohorT study using fMRI and EEG (CONNECT-ME) will import the full range of consciousness paradigms into neurocritical care. The investigators aim to assess patients with acute brain injury for preserved consciousness by serial multimodal evaluations using active, passive and resting state fMRI- and EEG-based paradigms. A prospective longitudinal database and a biobank for genomic and metabolomic research will be established. This approach will add essential clinical information, including detection of preserved consciousness in patients previously thought of as unconscious. Due to its complexity, this project is divided into nine work packages. Eventually, the investigators will have established a clinical service for the systematic assessment of covert consciousness, as well as an interdisciplinary research group dedicated to the neuronal mechanisms by which consciousness recovers after acute brain injury.

Conditions

  • Acute Brain Injuries
  • Consciousness Disorders

Sponsors & Collaborators

  • University of Copenhagen

    collaborator OTHER

  • Rigshospitalet, Denmark

    lead OTHER

Principal Investigators

  • Daniel Kondziella, MD PhD FEBN · Rigshospitalet, Department of Neurology

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-12
Primary Completion
2025-12-31
Completion
2025-12-31

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02644265 on ClinicalTrials.gov