NCT06568536 Measuring Brain Complexity to Detect and Predict Recovery of Consciousness in the ICU
| NCT ID | NCT06568536 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Massachusetts General Hospital |
| Condition | Consciousness Disorders |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2024-11-08 |
| Primary Completion | 2029-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 120 participants in total. It began in 2024-11-08 with a primary completion date of 2029-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
Eligibility 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.
Contact & Investigator
Brian L. Edlow, MD
PRINCIPAL INVESTIGATOR
Massachusetts General Hospital
Frequently Asked Questions
Who can join the NCT06568536 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Consciousness Disorders. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06568536 currently recruiting?
Yes, NCT06568536 is actively recruiting participants. Contact the research team at bedlow@mgh.harvard.edu for enrollment information.
Where is the NCT06568536 trial being conducted?
This trial is being conducted at Boston, United States, Madison, United States.
Who is sponsoring the NCT06568536 clinical trial?
NCT06568536 is sponsored by Massachusetts General Hospital. The principal investigator is Brian L. Edlow, MD at Massachusetts General Hospital. The trial plans to enroll 120 participants.