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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02644265
Recruitment Status : Recruiting
First Posted : December 31, 2015
Last Update Posted : August 28, 2018
University of Copenhagen
Information provided by (Responsible Party):
Daniel Kondziella, MD, MSc, PhD, FEBN, Rigshospitalet, Denmark

Brief 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.

Condition or disease
Acute Brain Injuries Consciousness Disorders

  Show Detailed Description

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: CONNECT-ME: CONsciousness in NEurocritical Care cohorT Study Using fMRI and EEG
Actual Study Start Date : April 12, 2017
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Numbers of patients with acute brain injury and signs of preserved consciousness as revealed by fMRI- and EEG-based active, passive and resting state consciousness paradigms [ Time Frame: 4 years ]

    The investigators aim to rigorously and systematically examine non-communicating patients with acute brain injury for preserved consciousness by means of active, passive and resting state fMRI- and EEG-based consciousness paradigms, as well as standardized clinical rating scales such as the JFK Coma Recovery Scale-Revised. The degree of consciousness in a given patient will be estimated by using a composite reference standard comprising all available fMRI- and EEG-derived as well as clinical data as previously described in a review and meta-analysis by the investigators.

    The target condition (primary outcome) is defined as signs of preserved consciousness in non-communicating patients with DoC due to traumatic brain injury (TBI), cerebrovascular disorders (CVA; including ischemic and hemorrhagic stroke, subarachnoid hemorrhage and cerebral venous sinus thrombosis), anoxic-ischemic encephalopathy (e.g., due to cardiac arrest) and similar critical brain disorders.

Biospecimen Retention:   Samples With DNA
Blood (serum), cerebrospinal fluid

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The target population comprises adult non-communicating patients with DoC due to TBI and non-TBI (age > 15 years). The investigators will apply the classical definition of consciousness as a "state of full awareness of the self and one's relationship to the environment". The term DoC includes patients in coma, VS/unresponsive wakefulness state (UWS), and MCS, as well as those who have emerged - but not completely - from MCS (eMCS).

Inclusion Criteria:

  • Non-responding patients (clinically defined as coma, VS/UWS, MCS, eMCS, or locked-in syndrome)
  • Acute or sub-acute TBI or non-TBI (≤28 days from injury)

Exclusion Criteria:

  • Contraindications for examination by MRI
  • Severe cardiorespiratory compromise and similar acutely life-threatening conditions
  • Evidence of severe pre-morbid neurological deficits such as aphasia or deafness
  • Lack of Danish or English language proficiency
  • Age less than 16 years
  • Evidence of defect auditory and sensory pathways (if clinically suspected or as revealed by pretest screening with brainstem auditory evoked potentials (BAEP) and somatosensory evoked potentials (SSEP))

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02644265

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Contact: Daniel Kondziella, MD PhD FEBN 0045-60131100
Contact: Kirsten Møller, MD DMSC

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Neurocentret, Rigshospitalet, Copenhagen University Recruiting
Copenhagen, Denmark, 2100
Contact: Daniel Kondziella         
Sponsors and Collaborators
Rigshospitalet, Denmark
University of Copenhagen
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Principal Investigator: Daniel Kondziella, MD PhD FEBN Rigshospitalet, Department of Neurology

Additional Information:

Study Data/Documents: Study Protocol  This link exits the site
Study Protocol Version 1.0

Rohaut B, Faugeras F NL. Neurology of consciousness impairments. In: Stevens RD, Sharshar T, Ely EW (eds.). Brain Disorders in Critical Illness. New York, NY: Cambridge University Press. Vol ; 2013:59-67
Posner J, Plum F, Saper C. Plum and Posner's Diagnosis of Stupor and Coma. New York, NY: Oxford University Press.; 2007

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Daniel Kondziella, MD, MSc, PhD, FEBN, Consultant Neurologist, Rigshospitalet, Denmark Identifier: NCT02644265     History of Changes
Other Study ID Numbers: CONNECT-ME 1.0
First Posted: December 31, 2015    Key Record Dates
Last Update Posted: August 28, 2018
Last Verified: August 2018

Keywords provided by Daniel Kondziella, MD, MSc, PhD, FEBN, Rigshospitalet, Denmark:
Acute acquired brain injury
Disorders of consciousness
Traumatic brain injury
Non-traumatic brain injury
Anoxic-ischemic encephalopathy
Vegetative state
Minimal conscious state
Locked-in syndrome
Functional magnetic resonance imaging

Additional relevant MeSH terms:
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Brain Injuries
Consciousness Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms
Neurocognitive Disorders
Mental Disorders