Clinical trial NCT06568536: Measuring Brain Complexity to Detect and Predict Recovery of Consciousness in the ICU
Official title: Measuring Brain Complexity to Detect and Predict Recovery of Consciousness in the ICU (COMPASS)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Consciousness Disorders
Keywords: unresponsive wakefulness syndrome
vegetative state
minimally conscious state
transcranial magnetic stimulation
electroencephalography
traumatic brain injury
coma recovery scale - revised
functional electroencephalogram
functional imaging
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: National Institute of Neurological Disorders and Stroke (NINDS)
First posted: 2024-08-23
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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
Primary purpose: DIAGNOSTIC

Brief 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.

Detailed 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 influences the recovery from disability and may affect family decisions about withdrawal of life-sustaining therapy (WLST). Transcranial magnetic stimulation-electroencephalography (TMS-EEG) has shown the best performance in detecting signs of consciousness in patients with chronic DoC. The goals of this multi-center observational study are to demonstrate the diagnostic performance and prognostic utility of TMS-EEG in patients with DoC caused by severe brain injuries in the ICU.

Through this research, we aim to demonstrate that:

* TMS-EEG can detect 95% of conscious patients who are defined as conscious by a combination of tests that aim to detect overt and covert consciousness.
* TMS-EEG measurements can predict 6-month outcomes on the Disability Rating Scale (DRS) in patients in an acute vegetative state, controlling for age, Glasgow Coma Scale (GCS) score, and injury mechanism

All participants will undergo repeated behavioral assessments, task-based electroencephalography (EEG), and TMS-EEG. Of note, conventional brain magnetic resonance imaging (MRI) and task-based functional MRI are optional.

Eligibility criteria: Inclusion 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

Additional inclusion criteria are present in the study protocol.

Exclusion Criteria:

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

If a subject meets a contraindication for MR imaging, the subject may participate in all other aspects of the study except MRI.

Primary outcomes:
measure: Presence of consciousness as defined by a composite reference standard for consciousness that combines behavior, task-based EEG, and task-based fMRI
timeFrame: 48 hours after the end of the TMS-EEG assessment
measure: Disability Rating Scale (DRS) total score
timeFrame: 6 months post injury
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Madison
country: United States
facility: UW Health University Hospital
state: Wisconsin
Study officials:
affiliation: Massachusetts General Hospital
name: Brian L. Edlow, MD
role: PRINCIPAL_INVESTIGATOR
References: