An observational study in Traumatic Brain Injury (TBI) Patients and Intracerebral Hemorrhage (ICH), sponsored by Columbia University. Recruiting at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-02.
Sponsored by Columbia University · Observational
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.
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.
1,721 studies on the registry are indexed under Brain Injuries, Traumatic; 447 are open to participants now.
This study's planned enrollment of 230 is above the median of 117 across 557 observational studies indexed under Brain Injuries, Traumatic.
Browse Brain Injuries, Traumatic studies →Columbia University is the lead sponsor of 1,136 studies on the registry; 195 are open to participants now.
Of its 180 completed or terminated interventional studies of FDA-regulated products, 148 (82%) have results posted.
Counted across the registry records on this site, refreshed daily.
Adult patients admitted to the ICU with acute neurological injury with Disorders of Consciousness (traumatic brain injury, and intracerebral hemorrhage) who demonstrate impaired consciousness and are unable to follow commands based on standardized clinical assessments (e.g., CRS-R).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
- 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:
Adult patients with acute neurological injury with Disorders of Consciousness (traumatic brain injury, and intracerebral hemorrhage).
P-value for prediction of the detection of cognitive motor dissociation (CMD)
P-value for separating move vs non-move instructions on power spectral density data using a support vector machine learning algorithm.
Time frame: Day 9
Prediction of recovery of consciousness by day 28 after brain injury
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.
Time frame: Day 28
Sleep as a prognosticator of long-term independence and disability after traumatic brain injury (TBI)
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.
Time frame: 12 months post injury
Sleep as a prognosticator of long-term disability after intracerebral hemorrhage (ICH)
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.
Time frame: 12 months post injury
Recovery of consciousness (CRS-R score ≥ 8)
Number of participants who have a Coma Recovery Scale-Revised (CRS-R) score of 8 or above.
Time frame: Day 28 after brain injury
Recovery of consciousness (CRS-R score = 10)
Number of participants who have a Coma Recovery Scale-Revised (CRS-R) score of 10.
Time frame: Day 28 after brain injury
Recovery of consciousness
Presence of subtle clinical signs of consciousness
Time frame: Day 28 after brain injury
Recovery of consciousness using the CRSR-FAST
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.
Time frame: Day 28 after brain injury
Recovery of consciousness (mean CRS-R score)
Average CRS-R scores following equal interval transformation using the partial credit Rash model.
Time frame: Day 28 after brain injury
Delirium as detected by the CAM-ICU score
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.
Time frame: Day 28 after brain injury
Recovery of independence for all patients
Number of participants who have a Glasgow Outcome Scale-Extended score of ≥4
Time frame: 12 month post injury
Long term disability
utility weighted transformation of modified Rankin Scale score
Time frame: 12 months after injury
Quality of life as per the Neuro-QOL scale
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.
Time frame: 12 months post injury
Disability
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.
Time frame: 12 months post injury
GOS-E sliding dichotomy for TBI participants
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
Time frame: 12 months post injury
GOS-E sliding dichotomy for ICH participants
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.
Time frame: 12 months
Return to work
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.
Time frame: 12 months
Started Oct 2026 (actual). Primary completion is estimated for Oct 2030, 48 months after the start.
Of 228 non-industry observational studies under Brain Injuries, Traumatic, half reached primary completion within 50 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 95. This study's planned 48 months is close to that.
Counting every sponsor, half of 250 studies reached it within 49 months; a quarter within 23 and three quarters within 95.
Since we started tracking on Sep 25, 2026, the dates moved once, on Nov 2, 2026: start Sep 2026 → Oct 2026, primary completion Sep 2030 → Oct 2030 and completion Sep 2031 → Oct 2031.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.