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New treatment option for Consciousness Disorders
Official title Measuring Brain Complexity to Detect and Predict Recovery of Consciousness in the ICU
ClinicalTrials.gov ID: NCT06568536
What this study is testing
- What it's testing
- 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).
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Continuous intravenous sedation able to be discontinued for at least 10 minutes
You likely can't join if
- 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...
- 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.
See the full eligibility criteria
- 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 are present in the study protocol.
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, United States
- Madison, Wisconsin, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Boston, Massachusetts, United States; Madison, Wisconsin, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.