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Measuring Brain Complexity to Detect and Predict Recovery of Consciousness in the ICU

RecruitingNAAges 18 Years - anyAllMassachusetts General Hospital
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: 1. Age greater than or equal to 18 2. Functionally independent at baseline 3. Acquired brain injury within the last 28 days 4. 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 5. Continuous intravenous sedation able to be discontinued for at least 10 minutes 6. ICU clinicians approve safe placement of 64-electrode EEG cap on the scalp Additional inclusion criteria are present in the study protocol. Exclusion Criteria: 1. Status epilepticus or uncontrolled seizure disorder 2. 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) 3. Medical instability, restlessness, or other factors identified by the PI that would either prevent safe participation or compromise data acquisition 4. 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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What it tests

  • Repeated behavioral assessments, functional electroencephalography and brain imagery, TMS-EEG
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Where

2 sites
Massachusetts General Hospital
Boston, United States
UW Health University Hospital
Madison, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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