An observational study in Traumatic Brain Injury (TBI) Patients, Intracerebral Hemorrhage and Subarachnoid Hemorrhage, sponsored by Columbia University. Recruiting at 9 sites in 5 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-04.
Sponsored by Columbia University · Observational
The purpose of this research study is to evaluate whether a smartphone-enabled EEG (electroencephalography) system can be used to detect Cognitive Motor Dissociation (CMD) in patients with acute neurological injuries who appear unable to follow commands at the bedside. CMD occurs when a person may be conscious and able to understand instructions but cannot physically respond. The study will also examine whether CMD detection is associated with short-term and long-term recovery outcomes.
Patients with severe neurological injuries, such as traumatic brain injury, intracerebral hemorrhage, subarachnoid hemorrhage, or cardiac arrest, may appear unresponsive even though some retain hidden awareness that cannot be detected through routine bedside examinations. This condition is known as Cognitive Motor Dissociation (CMD).
Research studies using EEG have shown that some patients who cannot physically respond to commands may still demonstrate brain activity indicating that they understand and can follow instructions. However, these EEG methods are not widely available because they often require specialized equipment and expertise.
The SMART-CMD study is being conducted to determine whether a smartphone-supported EEG paradigm can be feasibly implemented in intensive care units across multiple centers. The study will also evaluate whether the detection of CMD is associated with recovery during hospitalization and functional outcomes at six months after injury.
The SMART-CMD study aims to facilitate broader clinical implementation and improve diagnostic accuracy in the CMD detection.
1,824 studies on the registry are indexed under Brain Injuries, Traumatic; 462 are open to participants now.
This study's planned enrollment of 240 is above the median of 119 across 584 observational studies indexed under Brain Injuries, Traumatic.
Browse Brain Injuries, Traumatic studies →Columbia University is the lead sponsor of 1,137 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 (e.g., traumatic brain injury, intracerebral hemorrhage, subarachnoid hemorrhage, or cardiac arrest) who demonstrate impaired consciousness and are unable to follow commands based on standardized clinical assessments (e.g., CRS-R).
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Exclusion Criteria:
Adult patients with acute neurological injury with Disorders of Consciousness (Traumatic brain injury, intracerebral hemorrhage, subarachnoid hemorrhage, or cardiac arrest).
Number of assessments that are successfully obtained
The feasibility of implementing a smartphone-supported EEG paradigm for detection of CMD in ICU patients will be measured by the number of assessments that are successfully obtained (predicted greater or equal to 90%).
Time frame: Day 14 (or hospital discharge if that occurs earlier than 14 days)
Short term recovery of consciousness
The association between CMD status and short-term clinical outcomes will be evaluated using the Coma Recovery Scale-Revised Scale (CRS-R). The CRS-R score ranges from 0 to 23. Higher numbers indicate better performance.
Time frame: Day 14 (or hospital discharge if that occurs earlier than 14 days)
Recovery of independence
The association between CMD status and long-term functional outcomes will be evaluated using the Glasgow Outcome Score-Extended Scale (GOS-E). The GOS-E score ranges from 1 to 8. Higher numbers indicate better performance. Recovery of independence will be defined as a GOS-E score of 4 or above.
Time frame: 6 months
WHOQOL-BREF score
The association between CMD status and long-term quality of life will be measured by the WHOQOL-BREF (World Health Organization - Quality of Life - Brief). The WHOQOL-BREF is a 26-item self-report questionnaire designed to assess an individual's subjective quality of life. The full score range is 0 to 100. Higher numbers indicate better performance.
Time frame: 6 months
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Plan to share: No
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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 ↗
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