About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Repeated behavioral assessments, functional electroencephalography and brain imagery, TMS-EEG
Treatment groups
Sponsors and collaborators
Massachusetts General Hospital
Lead sponsor
National Institute of Neurological Disorders and Stroke (NINDS)
Collaborator