Actively Recruiting
Measuring Brain Complexity to Detect and Predict Recovery of Consciousness in the ICU (COMPASS)
Led by Massachusetts General Hospital · Updated on 2025-05-15
120
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
Sponsors
M
Massachusetts General Hospital
Lead Sponsor
N
National Institute of Neurological Disorders and Stroke (NINDS)
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to evaluate the ability of transcranial magnetic stimulation-electroencephalography (TMS-EEG) to detect and predict recovery of consciousness in adults with disorders of consciousness caused by severe brain injury in the intensive care unit (ICU). The study seeks to demonstrate how well TMS-EEG can identify conscious patients and predict their 6-month outcomes using the Disability Rating Scale (DRS), while addressing the challenge of assessing consciousness in this critical setting. Participants will undergo repeated behavioral assessments, task-based electroencephalography (EEG), and TMS-EEG while in the ICU. Optional brain magnetic resonance imaging (MRI) and task-based functional MRI may also be performed. The study follows patients for 6 months post-injury to monitor recovery and assess the prognostic value of TMS-EEG measurements. Throughout the study, researchers will perform repeated tests to evaluate consciousness levels using a combination of behavioral exams, EEG, and imaging. They will track brain complexity signals to compare with standard measures of consciousness and functional recovery after brain injury. Safety and data quality will be monitored, and participants' progress will be measured at 48 hours post-TMS-EEG and again at 6 months using the Disability Rating Scale.
CONDITIONS
Brief Title
Measuring Brain Complexity to Detect and Predict Recovery of Consciousness in the ICU
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Functionally independent before brain injury
- Acquired brain injury within the last 28 days
- Disorder of consciousness defined by no command following on two or more consecutive assessments
- Able to stop continuous intravenous sedation for at least 10 minutes
- ICU clinicians approve safe placement of 64-electrode EEG cap on the scalp
You will not qualify if you...
- Status epilepticus or uncontrolled seizure disorder
- No head CT scan from current hospital admission and contraindications for MRI such as implanted metal devices in the head
- Medical instability, restlessness, or other factors preventing safe participation or data collection
- Hemicraniectomy
- If contraindicated for MRI, can participate in all other assessments except MRI
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 28 days post brain injury
Participants undergo repeated behavioral assessments, task-based electroencephalography (EEG), transcranial magnetic stimulation-electroencephalography (TMS-EEG), and optional functional magnetic resonance imaging (MRI) to assess levels of consciousness.
Repeated assessments during ICU stay
Duration - 6 months post-injury
Participants are followed for up to 6 months post-injury to monitor recovery and assess outcomes using the Disability Rating Scale (DRS).
Follow-up visits at 48 hours after TMS-EEG assessment and at 6 months post-injury
Trial Site Locations
Total: 2 locations
1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
2
UW Health University Hospital
Madison, Wisconsin, United States, 53792
Not Yet Recruiting
Research Team
B
Brian L. Edlow, MD
M
Melanie Boly, MD, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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