Intracerebral Hemorrhage (ICH), Traumatic Brain Injury (TBI) Patients
Conditions
Keywords
cognitive motor dissociation (CMD), Disorders of Consciousness
Brief summary
Severe brain injuries can leave people in states where they are unconscious or only partly aware, such as a coma. These conditions are common after injuries like head trauma or bleeding in the brain. One of the biggest challenges for doctors is knowing if - or when - a patient will wake up and regain awareness. This research study is being done to determine if patterns in brain activity during sleep (measured by EEG) can help doctors better predict how quickly someone will wake up and recover after a serious brain injury, as well as how well they might do in the long term. It also aims to develop new ways of using EEG to track how the brain's networks heal and reconnect over time.
Detailed description
Disorders of consciousness (DoC), including coma and other states of impaired awareness, are common following severe acute brain injury, particularly traumatic brain injury (TBI) and intracerebral hemorrhage (ICH). Predicting whether and when these patients will recover consciousness remains one of the greatest challenges in neurocritical care. Current prognostic tools are limited, and inaccurate predictions may influence critical decisions regarding ongoing treatment and goals of care. Previous work has demonstrated that cognitive motor dissociation (CMD) - brain activation detected by EEG in response to motor commands despite the absence of observable behavioral responses - is associated with long-term recovery. However, CMD testing has important limitations, including false-negative results in patients with aphasia, hearing impairment, language barriers, or fluctuating arousal. Sleep architecture is profoundly disrupted after severe brain injury. Emerging evidence suggests that the presence of well-formed sleep spindles (WFSS) on EEG reflects preserved thalamocortical network integrity and is associated with recovery of consciousness and improved neurological outcomes. Sleep spindle detection offers a potentially scalable, inexpensive, and language-independent biomarker that can be obtained passively during routine EEG monitoring. This study seeks to determine whether EEG sleep features, particularly WFSS, can improve prediction of early recovery of consciousness and long-term neurological outcomes while also developing novel EEG-based measures of functional network recovery.
Interventions
None listed
Sponsors
Columbia University
Miami University
National Institute of Neurological Disorders and Stroke (NINDS)
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
\- Adults with non-penetrating traumatic brain injury (TBI) or with primary intracerebral hemorrhage (ICH) (i.e. from hypertension or anticoagulants) who remain behaviorally unresponsive to verbal commands (i.e., comatose vegetative state, or minimally conscious state minus \[MCS-minus, defined as unresponsive with preserved visual fixation/pursuit or localization to noxious stimuli\]) by day 2 after injury
Exclusion criteria
* Evidence of consciousness within 2 days of injury * Uncontrolled seizures * pre-existing disorders of consciousness * deafness
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| P-value for prediction of the detection of cognitive motor dissociation (CMD) | Day 9 | P-value for separating move vs non-move instructions on power spectral density data using a support vector machine learning algorithm. |
| Prediction of recovery of consciousness by day 28 after brain injury | Day 28 | Recovery of consciousness will be determined using the Coma Recovery Scale-Revised Scale (CRS-R) indexing consciousness as either minimally conscious state-plus (MCS-plus: the presence of signs of conscious awareness that include responses to commands or intelligible verbal output) or emergence from a minimally conscious state (EMCS: the return of the ability to use common objects in a functional manner or correctly respond to basic yes-or-no questions about situational orientation). Both would qualify as recovery of consciousness. The CRS-R full score ranges from 0 to 23, with higher scores representing higher levels of consciousness. |
| Sleep as a prognosticator of long-term independence and disability after traumatic brain injury (TBI) | 12 months post injury | This outcome will be assessed using the Glasgow Outcome Scale-Extended (GOS-E) Scale, which is an 8-level standardized clinical scale used to measure functional recovery and independence after a brain injury. Higher GOS-E scores indicate a better recovery, higher functional independence, and a greater return to normal daily activities. GOS-E score of ≥4 by 12-month post injury will serve as the primary measure to define independence indicating that the participant can be left alone at home for at least 8 hours in a day. |
| Sleep as a prognosticator of long-term disability after intracerebral hemorrhage (ICH) | 12 months post injury | This outcome will be assessed using the Modified Rankin Scale (mRS). The full score ranges from 0 to 6, measuring the degree of disability or dependence in daily activities. Higher scores mean greater disability and dependence, whereas lower scores mean better recovery and independence. Recovery from disability will be set at a score of 3 or below by 12 months post injury, indicating no more than moderate disability, where a person requires some help with daily activities but is still able to walk without assistance. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Recovery of consciousness (CRS-R score ≥ 8) | Day 28 after brain injury | Number of participants who have a Coma Recovery Scale-Revised (CRS-R) score of 8 or above. |
| Recovery of consciousness (CRS-R score = 10) | Day 28 after brain injury | Number of participants who have a Coma Recovery Scale-Revised (CRS-R) score of 10. |
| Recovery of consciousness | Day 28 after brain injury | Presence of subtle clinical signs of consciousness |
| Recovery of consciousness using the CRSR-FAST | Day 28 after brain injury | Coma Recovery Scale-Revised For Accelerated Standardized Testing (CRSR-FAST) score does not use a numerical scoring range like the full-length test; instead, it results in a binary rating of "conscious" or "not conscious." If at least one of the five core behaviors are present, the participant is considered conscious. |
| Recovery of consciousness (mean CRS-R score) | Day 28 after brain injury | Average CRS-R scores following equal interval transformation using the partial credit Rash model. |
| Delirium as detected by the CAM-ICU score | Day 28 after brain injury | The CAM-ICU (Confusion Assessment Method for the Intensive Care Unit) is a bedside tool used to screen for delirium in critically ill or mechanically ventilated patients. Instead of a numeric point scale, it yields a positive or negative result for delirium based on four specific clinical features. |
| Recovery of independence for all patients | 12 month post injury | Number of participants who have a Glasgow Outcome Scale-Extended score of ≥4 |
| Long term disability | 12 months after injury | utility weighted transformation of modified Rankin Scale score |
| Quality of life as per the Neuro-QOL scale | 12 months post injury | Quality of Life in Neurological Disorders (Neuro-QOL) to quantify quality of life as a patient-reported outcome measure. Neuro-QOL uses a standardized T-score metric where the mean of a reference population is set at 50 and the standard deviation is 10. Scores above or below 50 represent better or worse health-related quality of life than the reference group, depending on the specific symptom or functional domain. |
| Disability | 12 months post injury | Disability will be evaluated using the Disability Rating Scale (DRS), which ranges from 0 to 29, where higher scores indicate a greater level of impairment. |
| GOS-E sliding dichotomy for TBI participants | 12 months post injury | Evaluating recovery after traumatic brain injury (TBI) using a sliding dichotomy with the IMPACT Score tailors the definition of a "favorable" functional outcome to each participant's unique baseline prognosis. Instead of applying a single fixed cutoff (e.g., GOS-E ≥ 4 for everyone), this method sets a customized recovery threshold for each participant based on their predicted baseline risk profile. A participant recovering better than their individual baseline prediction is classified as a "favorable" outcome |
| GOS-E sliding dichotomy for ICH participants | 12 months | Evaluating recovery after intracerebral hemorrhage (ICH) using a sliding dichotomy with the FUNC Score tailors the definition of a "favorable" functional outcome to each participant's unique baseline prognosis. Instead of applying a single fixed cutoff, this method sets a customized recovery threshold for each participant based on their predicted baseline risk profile. A participant recovering better than their individual baseline prediction is classified as a "favorable" outcome. |
| Return to work | 12 months | Participants will be assessed if they were able to return to work as measured by the GOS-E with a score of 6 or above, indicating they are able to return to work even with special arrangements. |
Countries
United States
Contacts
CONTACTJan Claassen, MD
CONTACTAngela Velazquez, MD
Outcome results
None listed