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RECRUITING
NCT06568536
NA

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

Sponsor: Massachusetts General Hospital

View on ClinicalTrials.gov

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.

Official title: Measuring Brain Complexity to Detect and Predict Recovery of Consciousness in the ICU (COMPASS)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

120

Start Date

2024-11-08

Completion Date

2029-08-01

Last Updated

2025-05-15

Healthy Volunteers

No

Interventions

OTHER

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

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)

Massachusetts General Hospital

Boston, Massachusetts, United States

UW Health University Hospital

Madison, Wisconsin, United States