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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMassachusetts General Hospital

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

120 Participants
are divided into 1 treatment group

Sponsors and collaborators

Massachusetts General Hospital

Lead sponsor

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborator