Traumatic Brain Injury (TBI) PatientsSMART-CMDNCT07917728
Smartphone Enabled Detection of Cognitive Motor Dissociation in the ICU
An observational study of Traumatic Brain Injury (TBI) Patients and Intracerebral Hemorrhage, run by Columbia University at 9 sites in 5 countries.
Trial summary
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. 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, Subarachnoid Hemorrhage
- How many people
- 240 participants
- Where
- 9 sitesin 5 countries
- Study dates
- 27 Oct 2026to 1 Sep 2029
- 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 (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).
Who may be able to join
- Admitted for acute traumatic brain injury, intracerebral or subarachnoid hemorrhage, or cardiac arrest
- Neurological examination per Coma Recovery Scale-Revised (CRS-R) criteria consistent with coma, vegetative state, or minimally conscious state minus (not explained by sedation)
- Enrollment by day 7 post injury.
Who cannot join
- EEG demonstrating ongoing seizures or ictal interictal continuum
- Planned withdrawal of life sustaining therapy.
Trial locations and contacts
9 sites in 5 countries. Contact the study team or a site near you to ask about taking part.
9 sites in 5 countries
United States3 sites, 3 recruiting
- Not yet recruiting
University of Chicago Medical Center
Chicago, Illinois, 60657
Elizabeth E Carroll, MD, 773-702-6222, Elizabeth.Carroll@bsd.uchicago.edu
- 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
- Recruiting
Columbia University Irving Medical Center
New York, New York, 10032
Jan Claassen, MD, 212-305-7236, Jc1439@cumc.columbia.edu
Brazil2 sites, 2 recruiting
- Not yet recruiting
D'Or Institute of Research and Education
Botafogo, Rio de Janeiro, 22281-100
Fernando Bozza, MD, + 55 21 38836000, bozza.fernando@gmail.com
- Not yet recruiting
Instituto Estadual do Cérebro Paulo Niemeyer
Centro, Rio de Janeiro, 20231-092
Pedro Kurtz, MD, + 55 21 38124105 ext. 9352, kurtzpedro@mac.com
Japan2 sites, 2 recruiting
- Not yet recruiting
TMG Asaka Medical Center
Asaka, Saitama, 351-0023
Satoshi Egawa, MD, +81-48-466-2055, s.egawa7701@gmail.com
- Not yet recruiting
University of Tsukuba Hospital
Tsukuba, Ibaraki, 305-8576
Yuji Matsumaru, MD, +81-29-853-2951, yujimatsumaru@md.tsukuba.ac.jp
Canada1 site, 1 recruiting
- Not yet recruiting
Centre hospitalier de l'Université de Montréal (CHUM)
Montreal, Quebec, H2X 0C1
Joel Neves Briard, MD MSc, 514-890-8444, joel.neves.briard@umontreal.ca
Colombia1 site, 1 recruiting
- Not yet recruiting
Fundación Valle del Lili, University Hospital
Cali, Valle del Cauca Department, 7760040
Jorge H Mejía-Mantilla, MD, MSc, +57 315 489 6238, jorge.mejia@fvl.org.co
About this study
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.
Read the detailed description
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.
- Conditions
- Traumatic Brain Injury (TBI) Patients, Intracerebral Hemorrhage, Subarachnoid Hemorrhage, Cardiac Arrest (CA)
- Keywords
- Disorders of consciousness (DoC), Cognitive Motor Dissociation (CMD)
- Medical subject headings
- Brain Injuries, Traumatic, Cerebral Hemorrhage, Subarachnoid Hemorrhage, Heart Arrest, 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 |
|---|---|---|
| Traumatic brain injury, intracerebral hemorrhage, subarachnoid hemorrhage, or cardiac arrest. | Adult patients with acute neurological injury with Disorders of Consciousness (Traumatic brain injury, intracerebral hemorrhage, subarachnoid hemorrhage, or cardiac arrest). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%).
Measured: Day 14 (or hospital discharge if that occurs earlier than 14 days)
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2026
- Study start27 Oct 2026
- Primary completion1 Dec 2028 (estimated)
- Study completion1 Sep 2029 (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
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- Neurocritical Care Foundation
- Responsible party
- Principal investigator, Jan Claassen, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07917728
- Sponsor's protocol ID
- ACYY2976
- Acronym
- SMART-CMD
- Status last verified
- Oct 2026
- First submitted
- 30 Oct 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Smartphone Enabled Detection of Cognitive Motor Dissociation in the ICU
- ClinicalTrials.gov ID
- NCT07917728
- Acronym / sponsor ID
- SMART-CMD / ACYY2976
- Conditions
- Traumatic Brain Injury (TBI) Patients, Intracerebral Hemorrhage, Subarachnoid Hemorrhage, Cardiac Arrest (CA)
- Keywords
- Disorders of consciousness (DoC), Cognitive Motor Dissociation (CMD)
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- Neurocritical Care Foundation
- Study start
- 27 Oct 2026 (actual)
- Primary completion
- 1 Dec 2028 (estimated)
- Study completion
- 1 Sep 2029 (estimated)
- First posted
- 4 Nov 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.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Traumatic brain injury, intracerebral hemorrhage, subarachnoid hemorrhage, or cardiac arrest. | – | –Adult patients with acute neurological injury with Disorders of Consciousness (Traumatic brain injury, intracerebral hemorrhage, subarachnoid hemorrhage, or cardiac arrest). |
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 (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).
Key inclusion criteria (3 listed)
- Admitted for acute traumatic brain injury, intracerebral or subarachnoid hemorrhage, or cardiac arrest
- Neurological examination per Coma Recovery Scale-Revised (CRS-R) criteria consistent with coma, vegetative state, or minimally conscious state minus (not explained by sedation)
- Enrollment by day 7 post injury.
Key exclusion criteria (2 listed)
- EEG demonstrating ongoing seizures or ictal interictal continuum
- Planned withdrawal of life sustaining therapy.
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
Number of assessments that are successfully obtained
Time frame: Day 14 (or hospital discharge if that occurs earlier than 14 days)
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%).
3 secondary outcomes
Short term recovery of consciousness
Time frame: Day 14 (or hospital discharge if that occurs earlier than 14 days)
Recovery of independence
Time frame: 6 months
WHOQOL-BREF score
Time frame: 6 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 4 Nov 2026.
- Individual participant dataSharing planned: No
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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.
9 sites in 5 countries: 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, run by Columbia University at 9 sites in 5 countries.
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 3 inclusion and 2 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 4 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 9 sites in United States, Brazil, Japan, Canada, Colombia. 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?
Number of assessments that are successfully obtained (time frame: Day 14 (or hospital discharge if that occurs earlier than 14 days)). 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 4 Nov 2026.