CompletedNot Applicable

Feasibility of mindBEAGLE in Disorders of Consciousness or Locked-In Syndrome

United States20 participantsStarted 2016-03-01

Plain-language summary

The primary aims of this study are: 1. To determine the feasibility of deploying mindBEAGLE, a portable, bedside EEG-based system, in the Intensive Care Unit in patients with disorders of consciousness (DOC) or locked-in syndrome (LIS); 2. To determine if mindBEAGLE neurophysiologic markers of cognitive function correlate with bedside behavioral assessments of consciousness; 3. To determine if mindBEAGLE neurophysiologic markers of cognitive function correlate with functional MRI (fMRI) and electroencephalography (EEG) biomarkers of consciousness; 4. To determine if mindBEAGLE can serve as an assistive communication device for people with LIS.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age\>18 * Diagnosis of coma * Vegetative state * Minimally conscious state * Confusional state * Locked-in state Exclusion Criteria: • History of developmental, neurologic, or major psychiatric disorder resulting in functional disability

What they're measuring

Behavioral Diagnosis of Level of Consciousness (LoC)

Timeframe: on the day of intervention

Trial details

NCT IDNCT02772302

SponsorMassachusetts General Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-12-01

Results submitted2021-03-10

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