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)
Who can join
Ages 18 and older · All sexes
Full eligibility criteria
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.
About the study
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.
What is being tested
- Repeated behavioral assessments, functional electroencephalography and brain imagery, TMS-EEG (other)
Sponsor: Massachusetts General Hospital · Participants: 120 · Started: Nov 8, 2024
Contact the study team
- Brian L. Edlow, MD · Phone: 617-724-6352
Official record on ClinicalTrials.gov — NCT06568536
Locations in the U.S.
| Massachusetts | Massachusetts General Hospital, Boston |
| Wisconsin | UW Health University Hospital, Madison (Not yet recruiting) |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.