Sleep to Predict Recovery In Unconscious Patients With Acute Brain Injury

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorColumbia University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

Evidence of consciousness within 2 days of injury

Uncontrolled seizures

pre-existing disorders of consciousness

deafness

Trial 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).

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

230 Participants
are grouped into 1 trial group
Group A: Intracerebral Hemorrhage and Traumatic Brain Injury

Trial outcomes

Primary outcomes

1

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
2

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
3

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
4

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

Secondary outcomes

1

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
2

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
3

Recovery of consciousness

Presence of subtle clinical signs of consciousness

Time frame
Day 28 after brain injury
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Columbia University

Lead sponsor

Miami University

Collaborator

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborator

This trial is not recruiting at the moment. You can still explore other options: