Traumatic Brain Injury (TBI) PatientsSPRINTNCT07794605
Sleep to Predict Recovery In Unconscious Patients With Acute Brain Injury
An observational study of Traumatic Brain Injury (TBI) Patients and Intracerebral Hemorrhage (ICH), run by Columbia University at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Traumatic Brain Injury (TBI) Patients, Intracerebral Hemorrhage (ICH)
- How many people
- 230 participants
- Where
- 2 sitesUnited States
- Study dates
- 30 Oct 2026to 30 Oct 2031
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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).
Who may be able to join
- 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
Who cannot join
- Evidence of consciousness within 2 days of injury
- Uncontrolled seizures
- pre-existing disorders of consciousness
- deafness
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Not yet recruiting
University of Miami and Jackson Health System (UM/JHS)
Miami, Florida, 33136
Ayham Alkhachroum, MD, 305-243-6175, axa2610@med.miami.edu
Ayham Alkhachroum, MD
- Recruiting
Columbia University Medical Center
New York, New York, 10032
Jan Claassen, MD, 212-305-7236, jc1439@cumc.columbia.edu
Jan Claassen, MD
About this study
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.
Read the 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.
- Keywords
- cognitive motor dissociation (CMD), Disorders of Consciousness
- Medical subject headings
- Brain Injuries, Traumatic, Cerebral Hemorrhage, Consciousness Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Intracerebral Hemorrhage and Traumatic Brain Injury | Adult patients with acute neurological injury with Disorders of Consciousness (traumatic brain injury, and intracerebral hemorrhage). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 months post injury
Secondary outcomes (13)
Recovery of consciousness (CRS-R score ≥ 8)
Number of participants who have a Coma Recovery Scale-Revised (CRS-R) score of 8 or above.
Measured: 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.
Measured: Day 28 after brain injury
Recovery of consciousness
Presence of subtle clinical signs of consciousness
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Day 28 after brain injury
Recovery of independence for all patients
Number of participants who have a Glasgow Outcome Scale-Extended score of ≥4
Measured: 12 month post injury
Long term disability
utility weighted transformation of modified Rankin Scale score
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2026
- Study start30 Oct 2026
- Primary completion30 Oct 2030 (estimated)
- Study completion30 Oct 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain Injury (TBI) PatientsStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 230 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- Miami University, National Institute of Neurological Disorders and Stroke (NINDS)
- Responsible party
- Principal investigator, Jan Claassen, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07794605
- Sponsor's protocol ID
- ACYY2746
- Other IDs
- 1R01NS145481-01A1
- Acronym
- SPRINT
- Status last verified
- Oct 2026
- First submitted
- 26 Aug 2026
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep to Predict Recovery In Unconscious Patients With Acute Brain Injury
- ClinicalTrials.gov ID
- NCT07794605
- Acronym / sponsor ID
- SPRINT / ACYY2746
- Keywords
- cognitive motor dissociation (CMD), Disorders of Consciousness
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 230 participants (estimated)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- Miami University, National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- 30 Oct 2026 (actual)
- Primary completion
- 30 Oct 2030 (estimated)
- Study completion
- 30 Oct 2031 (estimated)
- First posted
- 31 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intracerebral Hemorrhage and Traumatic Brain Injury | – | –Adult patients with acute neurological injury with Disorders of Consciousness (traumatic brain injury, and intracerebral hemorrhage). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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).
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (4 listed)
- Evidence of consciousness within 2 days of injury
- Uncontrolled seizures
- pre-existing disorders of consciousness
- deafness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
P-value for prediction of the detection of cognitive motor dissociation (CMD)
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 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.
13 secondary outcomes
Recovery of consciousness (CRS-R score ≥ 8)
Time frame: Day 28 after brain injury
Recovery of consciousness (CRS-R score = 10)
Time frame: Day 28 after brain injury
Recovery of consciousness
Time frame: Day 28 after brain injury
Recovery of consciousness using the CRSR-FAST
Time frame: Day 28 after brain injury
Recovery of consciousness (mean CRS-R score)
Time frame: Day 28 after brain injury
Delirium as detected by the CAM-ICU score
Time frame: Day 28 after brain injury
Recovery of independence for all patients
Time frame: 12 month post injury
Long term disability
Time frame: 12 months after injury
Quality of life as per the Neuro-QOL scale
Time frame: 12 months post injury
Disability
Time frame: 12 months post injury
GOS-E sliding dichotomy for TBI participants
Time frame: 12 months post injury
GOS-E sliding dichotomy for ICH participants
Time frame: 12 months
Return to work
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Traumatic Brain Injury (TBI) Patients and Intracerebral Hemorrhage (ICH), run by Columbia University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jan Claassen, MD (212-305-7236, jc1439@cumc.columbia.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
P-value for prediction of the detection of cognitive motor dissociation (CMD) (time frame: Day 9). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.