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Measuring Brain Complexity to Detect and Predict Recovery of Consciousness in the ICU (COMPASS Trial)
N/A
Recruiting
Led By Brian L. Edlow, MD
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months post injury
Awards & highlights
No Placebo-Only Group
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.
Eligible Conditions
- Vegetative State or Minimally Conscious State
- Consciousness Disorders
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months post injury
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months post injury
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Disability Rating Scale (DRS) total score
Presence of consciousness as defined by a composite reference standard for consciousness that combines behavior, task-based EEG, and task-based fMRI
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Patients with acute disorders of consciousness receiving TMS-EEGExperimental Treatment1 Intervention
Adults with acute severe traumatic brain injury who undergo advanced neuroimaging and electrophysiological studies while in the intensive care unit and are followed for 6 months post-injury.
Find a Location
Who is running the clinical trial?
National Institute of Neurological Disorders and Stroke (NINDS)NIH
1,385 Previous Clinical Trials
652,568 Total Patients Enrolled
Massachusetts General HospitalLead Sponsor
3,026 Previous Clinical Trials
13,413,669 Total Patients Enrolled
Brian L. Edlow, MDPrincipal InvestigatorMassachusetts General Hospital