Feasibility of mindBEAGLE in Disorders of Consciousness or Locked-In Syndrome
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ClinicalTrials.gov Identifier: NCT02772302 |
Recruitment Status :
Completed
First Posted : May 13, 2016
Last Update Posted : May 21, 2020
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The primary aims of this study are:
- 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);
- To determine if mindBEAGLE neurophysiologic markers of cognitive function correlate with bedside behavioral assessments of consciousness;
- To determine if mindBEAGLE neurophysiologic markers of cognitive function correlate with functional MRI (fMRI) and electroencephalography (EEG) biomarkers of consciousness;
- To determine if mindBEAGLE can serve as an assistive communication device for people with LIS.
Condition or disease | Intervention/treatment | Phase |
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Consciousness Disorders Locked-In Syndrome | Device: mindBEAGLE EEG-based brain-computer interface | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 22 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Diagnostic |
Official Title: | Feasibility Study of the mindBEAGLE Device in Patients With Disorders of Consciousness or Locked-In Syndrome |
Actual Study Start Date : | March 1, 2016 |
Actual Primary Completion Date : | December 1, 2019 |
Actual Study Completion Date : | December 17, 2019 |

Arm | Intervention/treatment |
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Experimental: mindBEAGLE
Application of bedside, EEG-based mindBEAGLE Brain-Computer Interface
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Device: mindBEAGLE EEG-based brain-computer interface |
- Behavioral Diagnosis of Level of Consciousness (LoC) [ Time Frame: on the day of intervention ]LoC will be defined using the Coma Recovery Scale-Revised behavioral evaluation (score range 0-23)
- Neuroimaging Biomarkers of LoC [ Time Frame: within 1 week of the intervention ]functional MRI biomarkers of conscious awareness (+ or - activation during auditory stimulus)
- EEG Biomarkers of LoC [ Time Frame: within 1 week of the intervention ]resting EEG biomarkers of conscious awareness (power in delta, theta, and alpha frequency bands)

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Age>18
- Diagnosis of coma
- Vegetative state
- Minimally conscious state
- Confusional state
- Locked-in state

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02772302
United States, Massachusetts | |
Massachusetts General Hospital | |
Boston, Massachusetts, United States, 02114 |
Responsible Party: | Brian L. Edlow, M.D., Instructor of Neurology, Massachusetts General Hospital |
ClinicalTrials.gov Identifier: | NCT02772302 |
Other Study ID Numbers: |
2015P002731 |
First Posted: | May 13, 2016 Key Record Dates |
Last Update Posted: | May 21, 2020 |
Last Verified: | March 2020 |
Consciousness Disorders Quadriplegia Syndrome Disease Pathologic Processes Neurobehavioral Manifestations |
Neurologic Manifestations Nervous System Diseases Neurocognitive Disorders Mental Disorders Paralysis |