CONNECT-ME: Consciousness in Neurocritical Care Cohort Study Using fMRI and EEG
Launched by RIGSHOSPITALET, DENMARK · Dec 29, 2015
Trial Information
Current as of August 20, 2025
Recruiting
Keywords
ClinConnect Summary
The CONNECT-ME trial is studying how we can better detect consciousness in patients who have experienced acute brain injuries, such as traumatic brain injuries or strokes. Sometimes, patients may appear unresponsive and be misdiagnosed as being in a vegetative state, but they might actually have some level of consciousness. This study aims to use advanced techniques like functional magnetic resonance imaging (fMRI) and electroencephalography (EEG) to identify any signs of preserved consciousness, even in patients who cannot move or respond.
To be eligible for this trial, patients must be adults who are not responding due to their brain injury and have been injured within the last 28 days. Unfortunately, those with certain severe medical conditions or serious pre-existing neurological issues will not be able to participate. If enrolled, participants will undergo a series of tests using fMRI and EEG to evaluate their brain activity, which will help researchers learn more about their consciousness. This study could lead to better understanding and treatment options for patients with brain injuries, providing hope for improved outcomes.
Gender
ALL
Eligibility criteria
- 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))
About Rigshospitalet, Denmark
Rigshospitalet, located in Copenhagen, Denmark, is one of the leading hospitals in Scandinavia and a prominent center for clinical research and innovation. As a key academic institution affiliated with the University of Copenhagen, Rigshospitalet is dedicated to advancing healthcare through rigorous clinical trials and groundbreaking research across various medical disciplines. The hospital’s commitment to excellence is reflected in its multidisciplinary approach, collaboration with international research networks, and focus on improving patient outcomes through evidence-based practices. With state-of-the-art facilities and a team of highly qualified professionals, Rigshospitalet plays a crucial role in translating scientific discoveries into effective treatments and therapies.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Copenhagen, , Denmark
Patients applied
Trial Officials
Daniel Kondziella, MD PhD FEBN
Principal Investigator
Rigshospitalet, Department of Neurology
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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