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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-08

Study Completion Date

2029-08-01

Brief Summary

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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.

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Detailed Description

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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 influences the recovery from disability and may affect family decisions about withdrawal of life-sustaining therapy (WLST). Transcranial magnetic stimulation-electroencephalography (TMS-EEG) has shown the best performance in detecting signs of consciousness in patients with chronic DoC. The goals of this multi-center observational study are to demonstrate the diagnostic performance and prognostic utility of TMS-EEG in patients with DoC caused by severe brain injuries in the ICU.

Through this research, we aim to demonstrate that:

* TMS-EEG can detect 95% of conscious patients who are defined as conscious by a combination of tests that aim to detect overt and covert consciousness.
* TMS-EEG measurements can predict 6-month outcomes on the Disability Rating Scale (DRS) in patients in an acute vegetative state, controlling for age, Glasgow Coma Scale (GCS) score, and injury mechanism

All participants will undergo repeated behavioral assessments, task-based electroencephalography (EEG), and TMS-EEG. Of note, conventional brain magnetic resonance imaging (MRI) and task-based functional MRI are optional.

Conditions

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Consciousness Disorders

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Of note, while this is not a "multi-arm" randomized controlled trial, the outcome assessor for the 6-month functional outcome will be blinded to the patient's level of consciousness that was assessed in the ICU.

Study Groups

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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.

Group Type EXPERIMENTAL

Repeated behavioral assessments, functional electroencephalography and brain imagery, TMS-EEG

Intervention Type 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

Interventions

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Repeated behavioral assessments, functional electroencephalography and brain imagery, TMS-EEG

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

Intervention Type OTHER

Eligibility Criteria

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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

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No