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

Description

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.

Conditions

Consciousness Disorders

Study Overview

Study Details

Study overview

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.

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

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

Condition
Consciousness Disorders
Intervention / Treatment

-

Contacts and Locations

Boston

Massachusetts General Hospital, Boston, Massachusetts, United States, 02114

Madison

UW Health University Hospital, Madison, Wisconsin, United States, 53792

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Massachusetts General Hospital,

Brian L. Edlow, MD, PRINCIPAL_INVESTIGATOR, Massachusetts General Hospital

Study Record Dates

2029-08-01