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

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Massachusetts General Hospital
Study ID
NCT06568536
Status
Recruiting
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Conditions

  • Consciousness Disorders

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Repeated behavioral assessments, functional electroencephalography and brain imagery, TMS-EEG — OTHER
    The presence of consciousness will be classified considering the highest level of consciousness revealed by repeated behavioral examinations, functional electroencephalography (task-based EEG), and functional brain imagery (task-based fMRI). Based on the results of this composite standard reference, we will evaluate the diagnostic and prognostic accuracy of TMS-EEG measurements of brain complexity

Study Details

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.

Key Dates

Start date
Nov 8, 2024
Status verified
May 2025
Primary completion
Aug 31, 2029
Completion
Aug 1, 2029

Study Design

Enrollment
120 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Patients with acute disorders of consciousness receiving TMS-EEG
    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.

Primary Outcome Measure

Presence of consciousness as defined by a composite reference standard for consciousness that combines behavior, task-based EEG, and task-based fMRI [ Time Frame: 48 hours after the end of the TMS-EEG assessment ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Massachusetts General HospitalBostonMassachusetts02114
Brian L Edlow, MD
[email protected]
617-724-6352
Brian L. Edlow, MD (PRINCIPAL_INVESTIGATOR)
Matteo Fecchio, PhD (SUB_INVESTIGATOR)
UW Health University HospitalMadisonWisconsin53792
Melanie Boly, MD, PhD
Melanie Boly, MD, PhD (PRINCIPAL_INVESTIGATOR)

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