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

NCT02644265 | Unknown DMC

• 1 other identifier: CONNECT-ME 1.0
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Brain Injuries; Consciousness Disorders

Keywords

Acute acquired brain injury; Disorders of consciousness; Traumatic brain injury; Non-traumatic brain injury; Anoxic-ischemic encephalopathy; Stroke; Vegetative state; Minimal conscious state; Locked-in syndrome; Functional magnetic resonance imaging; Electroencephalography

Outcome Measures

Primary Outcomes (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

  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.

  4 years

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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)

You may not qualify if:

• 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))

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead
• University of Copenhagen: collaborator

Study Sites (1)

Neurocentret, Rigshospitalet, Copenhagen University

Copenhagen, 2100, Denmark

RECRUITING

Related Publications (33)

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• Owen AM, Coleman MR, Boly M, Davis MH, Laureys S, Pickard JD. Detecting awareness in the vegetative state. Science. 2006 Sep 8;313(5792):1402. doi: 10.1126/science.1130197.

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• American Congress of Rehabilitation Medicine, Brain Injury-Interdisciplinary Special Interest Group, Disorders of Consciousness Task Force; Seel RT, Sherer M, Whyte J, Katz DI, Giacino JT, Rosenbaum AM, Hammond FM, Kalmar K, Pape TL, Zafonte R, Biester RC, Kaelin D, Kean J, Zasler N. Assessment scales for disorders of consciousness: evidence-based recommendations for clinical practice and research. Arch Phys Med Rehabil. 2010 Dec;91(12):1795-813. doi: 10.1016/j.apmr.2010.07.218.

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• Amiri M, Raimondo F, Fisher PM, Cacic Hribljan M, Sidaros A, Othman MH, Zibrandtsen I, Bergdal O, Fabritius ML, Hansen AE, Hassager C, Hojgaard JLS, Jensen HR, Knudsen NV, Laursen EL, Moller JE, Nersesjan V, Nicolic M, Sigurdsson ST, Sitt JD, Solling C, Welling KL, Willumsen LM, Hauerberg J, Larsen VA, Fabricius ME, Knudsen GM, Kjaergaard J, Moller K, Kondziella D. Multimodal Prediction of 3- and 12-Month Outcomes in ICU Patients with Acute Disorders of Consciousness. Neurocrit Care. 2024 Apr;40(2):718-733. doi: 10.1007/s12028-023-01816-z. Epub 2023 Sep 11.

  PMID: 37697124 DERIVED

• Amiri M, Fisher PM, Raimondo F, Sidaros A, Cacic Hribljan M, Othman MH, Zibrandtsen I, Albrechtsen SS, Bergdal O, Hansen AE, Hassager C, Hojgaard JLS, Jakobsen EW, Jensen HR, Moller J, Nersesjan V, Nikolic M, Olsen MH, Sigurdsson ST, Sitt JD, Solling C, Welling KL, Willumsen LM, Hauerberg J, Larsen VA, Fabricius M, Knudsen GM, Kjaergaard J, Moller K, Kondziella D. Multimodal prediction of residual consciousness in the intensive care unit: the CONNECT-ME study. Brain. 2023 Jan 5;146(1):50-64. doi: 10.1093/brain/awac335.

  PMID: 36097353 DERIVED

• Skibsted AP, Amiri M, Fisher PM, Sidaros A, Hribljan MC, Larsen VA, Hojgaard JLS, Nikolic M, Hauerberg J, Fabricius ME, Knudsen GM, Moller K, Kondziella D. Consciousness in Neurocritical Care Cohort Study Using fMRI and EEG (CONNECT-ME): Protocol for a Longitudinal Prospective Study and a Tertiary Clinical Care Service. Front Neurol. 2018 Nov 27;9:1012. doi: 10.3389/fneur.2018.01012. eCollection 2018.

  PMID: 30542319 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood (serum), cerebrospinal fluid

MeSH Terms

Conditions

Brain Injuries; Consciousness Disorders; Brain Injuries, Traumatic; Hypoxia-Ischemia, Brain; Stroke; Persistent Vegetative State; Locked-In Syndrome

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Brain Ischemia; Cerebrovascular Disorders; Hypoxia, Brain; Vascular Diseases; Cardiovascular Diseases; Hypoxia; Signs and Symptoms, Respiratory; Brain Damage, Chronic; Unconsciousness; Quadriplegia; Paralysis; Neuromuscular Diseases

Study Officials

• Daniel Kondziella, MD PhD FEBN

  Rigshospitalet, Department of Neurology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Daniel Kondziella, MD PhD FEBN

CONTACT

0045-60131100; daniel_kondziella@yahoo.com

Kirsten Møller, MD DMSC

CONTACT

kirsten.moeller.01@regionh.dk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Neurologist

Study Record Dates

• First Submitted: December 25, 2015
• First Posted: December 31, 2015
• Study Start: April 12, 2017
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: November 15, 2023

Record last verified: 2023-11

Locations

DK (1)