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

Recruiting now · Not applicable

Conditions studied: Consciousness Disorders

In brief

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.

Key facts

Study ID

NCT06568536

Run by

Massachusetts General Hospital

People needed

120

Starts

2024-11-08

Expected to finish

2029-08-01

Last updated by the study team

2025-05-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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
• Additional inclusion criteria are present in the study protocol.

You may not qualify if…

• 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.

Where it is running

• Massachusetts General Hospital — Boston, Massachusetts, United States (enrolling)
• UW Health University Hospital — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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