Actively Recruiting
Measuring Brain Complexity to Detect and Predict Recovery of Consciousness in the ICU
Led by Massachusetts General Hospital · Updated on 2025-05-15
120
Participants Needed
2
Research Sites
246 weeks
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
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
Official 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 greater than or equal to 18
- Functionally independent at baseline
- Acquired brain injury within the last 28 days
- Disorder of consciousness with no command following on two or more consecutive assessments
- Continuous intravenous sedation that can be stopped for at least 10 minutes
- ICU clinicians approve safe placement of a 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 magnetic-sensitive metals in the head
- Medical instability, restlessness, or other factors preventing safe participation or data quality
- Hemicraniectomy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
M
Melanie Boly, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here