Smartphone-based EEG to detect hidden awareness in ICU patients with brain injuries
Official title: Smartphone Enabled Detection of Cognitive Motor Dissociation in the ICU
Run by Columbia University · NCT07917728 · Data updated 2026-11-12
Researchers will test a smartphone-enabled EEG to see if it can reveal Cognitive Motor Dissociation in ICU patients who can’t show commands at bedside.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 240 (estimated) |
| Sponsor | Columbia University Academic / other |
| Locations | 9 sites (Miami, Florida and 8 other locations) |
| Status | Recruiting |
| Started | October 27, 2026 |
| Main results expected | December 1, 2028 |
| Study ends | September 1, 2029 |
| Registry record updated | November 4, 2026 |
| Trial ID | NCT07917728 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with acute TBI, intracerebral or subarachnoid hemorrhage, or cardiac arrest who are comatose, vegetative, or minimally conscious and enrolled by day 7 post-injury.
✕Probably not a fit
Patients with ongoing seizures, ictal-interictal activity, or plans to withdraw life-sustaining therapy may not benefit from this testing.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study investigates whether a smartphone-supported EEG protocol can identify Cognitive Motor Dissociation in adults with acute traumatic brain injury, intracerebral hemorrhage, subarachnoid hemorrhage, or cardiac arrest who appear unresponsive. The goal is to determine if CMD detection correlates with recovery outcomes during hospitalization and at six months post-injury. The study aims to assess feasibility of implementing the smartphone EEG across multiple ICUs and centers. It will exclude patients with ongoing seizures or where life-sustaining therapy is planned to be withdrawn. Colonies: multi-center participation includes sites in New York, Chicago, and Miami/Jackson Health System, led by Columbia University with collaborators from Neurocritical Care Foundation.
Why it matters
Potential benefit: If successful, this approach could improve diagnostic accuracy for hidden consciousness and help guide prognosis and care decisions.
How similar studies have gone: Previous EEG-based methods have shown promise in detecting hidden awareness, but smartphone-enabled approaches in ICUs are being evaluated for feasibility and accuracy.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Admitted for acute traumatic brain injury, intracerebral or subarachnoid hemorrhage, or cardiac arrest 2. Neurological examination per Coma Recovery Scale-Revised (CRS-R) criteria consistent with coma, vegetative state, or minimally conscious state minus (not explained by sedation) 3. Enrollment by day 7 post injury. Exclusion Criteria: 1. EEG demonstrating ongoing seizures or ictal interictal continuum 2. Planned withdrawal of life sustaining therapy.
Where it's running
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Columbia University Irving Medical Center
New York, New York, United States Recruiting -
University of Miami and Jackson Health System (UM/JHS)
Miami, Florida, United States Not yet recruiting -
University of Chicago Medical Center
Chicago, Illinois, United States Not yet recruiting -
D'Or Institute of Research and Education
Botafogo, Rio de Janeiro, Brazil Not yet recruiting -
Instituto Estadual do Cérebro Paulo Niemeyer
Centro, Rio de Janeiro, Brazil Not yet recruiting -
Centre hospitalier de l'Université de Montréal (CHUM)
Montreal, Quebec, Canada Not yet recruiting
Show 3 more locations
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Fundación Valle del Lili, University Hospital
Cali, Valle del Cauca Department, Colombia Not yet recruiting -
University of Tsukuba Hospital
Tsukuba, Ibaraki, Japan Not yet recruiting -
TMG Asaka Medical Center
Asaka, Saitama, Japan Not yet recruiting
Study contacts
- Study coordinator: Jan Claassen, MD
- Email: JC1439@cumc.columbia.edu
- Phone: 212-305-7236
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.