Assessing consciousness in brain-injured patients using fMRI and EEG
CONNECT-ME: CONsciousness in NEurocritical Care cohorT Study Using fMRI and EEG
This study is trying to see if new brain imaging techniques can help find out if patients with severe brain injuries are still aware, even if they can't communicate.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 16 Years and up |
| Sex | All |
| Sponsor | Rigshospitalet, Denmark Academic / other |
| Locations | 1 site (Copenhagen) |
| Trial ID | NCT02644265 on ClinicalTrials.gov |
What this trial studies
This study aims to detect preserved consciousness in patients with acute brain injuries who are unable to communicate. By utilizing advanced technologies like functional magnetic resonance imaging (fMRI) and electroencephalography (EEG), the study seeks to identify patients who may be misclassified as being in a vegetative state. The approach focuses on cognitive tasks that patients can perform mentally, which may indicate their level of consciousness. This research is crucial for improving prognosis, treatment decisions, and resource allocation for these patients.
Who should consider this trial
Good fit: Ideal candidates for this study are non-responding patients with acute or sub-acute brain injuries, including those in a coma, vegetative state, or minimally conscious state.
Not a fit: Patients with severe pre-existing neurological deficits or those unable to undergo MRI due to contraindications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more accurate assessments of consciousness in brain-injured patients, improving their treatment and care.
How similar studies have performed: Other studies have shown promise in using fMRI and EEG to assess consciousness, suggesting that this approach could be effective.
Eligibility criteria
Show full inclusion / exclusion 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))
Where this trial is running
Copenhagen
- Neurocentret, Rigshospitalet, Copenhagen University — Copenhagen, Denmark (Recruiting)
Study contacts
- Principal investigator: Daniel Kondziella, MD PhD FEBN — Rigshospitalet, Department of Neurology
- Study coordinator: Daniel Kondziella, MD PhD FEBN
- Email: daniel_kondziella@yahoo.com
- Phone: 0045-60131100
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.