Measuring Brain Complexity to Detect and Predict Recovery of Consciousness in the ICU
Measuring Brain Complexity to Detect and Predict Recovery of Consciousness in the ICU (COMPASS)
Massachusetts General Hospital
120 participants
Nov 8, 2024
INTERVENTIONAL
Conditions
Summary
Disorders of consciousness (DoC) caused by severe brain injury affect millions of people worldwide each year. A patient's level of consciousness in the intensive care unit (ICU) significantly impacts the recovery from disability and is a primary determinant of family decisions about withdrawal of life-sustaining therapy (WLST). However, reliable assessment of consciousness in the ICU remains elusive. Transcranial magnetic stimulation-electroencephalography (TMS-EEG) is a tool that has shown the best performance in detecting signs of consciousness in patients with chronic DoC. The goals of this prospective, observational study are to demonstrate the diagnostic performance and prognostic utility of TMS-EEG in the ICU setting.
Eligibility
Inclusion Criteria6
- Age greater than or equal to 18
- Functionally independent at baseline
- Acquired brain injury within the last 28 days
- Disorder of consciousness, as defined by no instance of following commands (i.e., Glasgow Coma Scale motor score = 6) on two or more consecutive assessments
- Continuous intravenous sedation able to be discontinued for at least 10 minutes
- ICU clinicians approve safe placement of 64-electrode EEG cap on the scalp
Exclusion Criteria5
- Status epilepticus or uncontrolled seizure disorder
- No head CT scan from current hospital admission AND contraindications for MRI: conductive, ferromagnetic, or other magnetic-sensitive metals implanted in the head (e.g., cochlear implants, implanted electrodes/stimulators, aneurysm clips or coils, stents, bullet fragments)
- Medical instability, restlessness, or other factors identified by the PI that would either prevent safe participation or compromise data acquisition
- Hemicraniectomy
- If a subject meets a contraindication for MR imaging, the subject may participate in all other aspects of the study except MRI.
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Interventions
The presence of consciousness will be classified considering the highest level of consciousness revealed by repeated behavioral examinations, functional electroencephalography (task-based EEG), and functional brain imagery (task-based fMRI). Based on the results of this composite standard reference, we will evaluate the diagnostic and prognostic accuracy of TMS-EEG measurements of brain complexity
Locations(2)
View Full Details on ClinicalTrials.gov
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NCT06568536