Measuring brain activity to assess consciousness recovery in ICU patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Focused ultrasound to promote recovery after severe brain injury.

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• Targeted thalamic ultrasound to help recovery after severe brain injury

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• Using Vagus Nerve Stimulation and Robotic Mobilization for Patients with Prolonged Disorders of Consciousness

  This study is testing if combining a special nerve stimulation treatment with robotic help to move can improve the recovery of patients who have been in a prolonged state of unconsciousness.

  Recruiting Icahn School of Medicine at Mount Sinai · New York, New York · NCT06930716

• Investigating brain activity and consciousness in patients with severe brain injuries

  This study is testing a new way to monitor brain activity in patients with severe brain injuries to see if it can help doctors understand their level of consciousness and improve their treatment.

  Recruiting Universitaire Ziekenhuizen KU Leuven · Leuven, Vlaams-Brabant · NCT06426615

• Observing micro-movements in patients with prolonged disorders of consciousness

  This study is trying to see if tiny movements in patients with prolonged disorders of consciousness can help us understand their level of awareness and improve their care.

  Recruiting First Affiliated Hospital of Zhejiang University · Hanzhou, Zhejiang · NCT06406413

• Understanding micro-expressions in patients with prolonged disorders of consciousness

  This study is trying to see if watching emotional videos can help understand the tiny facial expressions of patients with prolonged disorders of consciousness and improve how doctors assess their awareness.

  Recruiting First Affiliated Hospital of Zhejiang University · Hangzhou, Zhejiang · NCT06088628

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.