RECRUITING

Measuring Brain Complexity to Detect and Predict Recovery of Consciousness in the ICU

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Measuring Brain Complexity to Detect and Predict Recovery of Consciousness in the ICU (COMPASS)

Quick Facts

Study Start:2024-11-08
Study Completion:2029-08-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06568536

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Age greater than or equal to 18
  2. 2. Functionally independent at baseline
  3. 3. Acquired brain injury within the last 28 days
  4. 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. 5. Continuous intravenous sedation able to be discontinued for at least 10 minutes
  6. 6. ICU clinicians approve safe placement of 64-electrode EEG cap on the scalp
  1. 1. Status epilepticus or uncontrolled seizure disorder
  2. 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. 3. Medical instability, restlessness, or other factors identified by the PI that would either prevent safe participation or compromise data acquisition
  4. 4. Hemicraniectomy

Contacts and Locations

Study Contact

Brian L. Edlow, MD
CONTACT
617-724-6352
bedlow@mgh.harvard.edu
Melanie Boly, MD, PhD
CONTACT
boly@neurology.wisc.edu

Principal Investigator

Brian L. Edlow, MD
PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital

Study Locations (Sites)

Massachusetts General Hospital
Boston, Massachusetts, 02114
United States
UW Health University Hospital
Madison, Wisconsin, 53792
United States

Collaborators and Investigators

Sponsor: Massachusetts General Hospital

  • Brian L. Edlow, MD, PRINCIPAL_INVESTIGATOR, Massachusetts General Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-11-08
Study Completion Date2029-08-01

Study Record Updates

Study Start Date2024-11-08
Study Completion Date2029-08-01

Terms related to this study

Keywords Provided by Researchers

  • unresponsive wakefulness syndrome
  • vegetative state
  • minimally conscious state
  • transcranial magnetic stimulation
  • electroencephalography
  • traumatic brain injury
  • coma recovery scale - revised
  • functional electroencephalogram
  • functional imaging

Additional Relevant MeSH Terms

  • Consciousness Disorders