Measuring brain activity to assess consciousness recovery in ICU patients
Measuring Brain Complexity to Detect and Predict Recovery of Consciousness in the ICU (COMPASS)
This study is testing a new method using brain scans to see if it can help doctors understand if ICU patients with severe brain injuries are aware and how likely they are to recover.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Massachusetts General Hospital Academic / other |
| Locations | 2 sites (Boston, Massachusetts and 1 other locations) |
| Trial ID | NCT06568536 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on patients with disorders of consciousness (DoC) due to severe brain injuries in the ICU. It aims to evaluate the effectiveness of transcranial magnetic stimulation-electroencephalography (TMS-EEG) in detecting signs of consciousness and predicting recovery outcomes. Participants will undergo repeated behavioral assessments and TMS-EEG measurements to determine their level of consciousness and potential for recovery over a six-month period. The study seeks to improve the understanding of consciousness in critically ill patients and inform family decisions regarding life-sustaining therapies.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a recent acquired brain injury and a disorder of consciousness as defined by specific clinical criteria.
Not a fit: Patients with uncontrolled seizure disorders, medical instability, or contraindications for EEG placement may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a reliable method for assessing consciousness in ICU patients, potentially improving patient outcomes and guiding treatment decisions.
How similar studies have performed: Previous studies using TMS-EEG have shown promise in detecting consciousness in chronic DoC patients, suggesting potential success in this novel application.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Boston, Massachusetts and 1 other locations
- Massachusetts General Hospital — Boston, Massachusetts, United States (Recruiting)
- UW Health University Hospital — Madison, Wisconsin, United States (Not_yet_recruiting)
Study contacts
- Principal investigator: Brian L. Edlow, MD — Massachusetts General Hospital
- Study coordinator: Brian L. Edlow, MD
- Email: bedlow@mgh.harvard.edu
- Phone: 617-724-6352
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.