Feasibility of mindBEAGLE in Disorders of Consciousness or Locked-In Syndrome
NCT ID: NCT02772302
Last Updated: 2021-06-03
Study Results
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View full resultsBasic Information
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COMPLETED
NA
20 participants
INTERVENTIONAL
2016-03-01
2019-12-17
Brief Summary
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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.
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Detailed Description
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2. To determine if mindBEAGLE neurophysiologic markers of cognitive function correlate with bedside behavioral assessments of consciousness;
3. To determine if mindBEAGLE can serve as an assistive communication device for people with LIS.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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Patients
Application of bedside, EEG-based mindBEAGLE Brain-Computer Interface
mindBEAGLE EEG-based brain-computer interface
Healthy Controls
Application of bedside, EEG-based mindBEAGLE Brain-Computer Interface
mindBEAGLE EEG-based brain-computer interface
Interventions
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mindBEAGLE EEG-based brain-computer interface
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of coma
* Vegetative state
* Minimally conscious state
* Confusional state
* Locked-in state
Exclusion Criteria
18 Years
ALL
Yes
Sponsors
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Massachusetts General Hospital
OTHER
Responsible Party
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Brian L. Edlow, M.D.
Instructor of Neurology
Principal Investigators
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Brian L. Edlow, M.D.
Role: PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital
Locations
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Massachusetts General Hospital
Boston, Massachusetts, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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Feasibility of an EEG-based brain-computer interface in the intensive care unit
Other Identifiers
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2015P002731
Identifier Type: -
Identifier Source: org_study_id
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