Status:
RECRUITING
Measuring Brain Complexity to Detect and Predict Recovery of Consciousness in the ICU
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
National Institute of Neurological Disorders and Stroke (NINDS)
Conditions:
Consciousness Disorders
Eligibility:
All Genders
18+ years
Phase:
NA
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 ...
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 influenc...
Eligibility Criteria
Inclusion
- 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
- Continuous intravenous sedation able to be discontinued for at least 10 minutes
- ICU clinicians approve safe placement of 64-electrode EEG cap on the scalp
- Additional inclusion criteria are present in the study protocol.
Exclusion
- 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
- If a subject meets a contraindication for MR imaging, the subject may participate in all other aspects of the study except MRI.
Key Trial Info
Start Date :
November 8 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2029
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT06568536
Start Date
November 8 2024
End Date
August 1 2029
Last Update
May 15 2025
Active Locations (2)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
2
UW Health University Hospital
Madison, Wisconsin, United States, 53792