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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02772302
Recruitment Status : Completed
First Posted : May 13, 2016
Last Update Posted : May 21, 2020
Sponsor:
Information provided by (Responsible Party):
Brian L. Edlow, M.D., Massachusetts General Hospital

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Consciousness Disorders Locked-In Syndrome Device: mindBEAGLE EEG-based brain-computer interface Not Applicable

Study Design
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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

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Arms and Interventions
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Arm Intervention/treatment
Experimental: mindBEAGLE
Application of bedside, EEG-based mindBEAGLE Brain-Computer Interface
 Device: mindBEAGLE EEG-based brain-computer interface


Outcome Measures
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Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. Neuroimaging Biomarkers of LoC [ Time Frame: within 1 week of the intervention ]
    functional MRI biomarkers of conscious awareness (+ or - activation during auditory stimulus)

  2. 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)


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age>18
  • Diagnosis of coma
  • Vegetative state
  • Minimally conscious state
  • Confusional state
  • Locked-in state
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
More Information
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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
Additional relevant MeSH terms:
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Consciousness Disorders
Quadriplegia
Syndrome
Disease
Pathologic Processes
Neurobehavioral Manifestations
 Neurologic Manifestations
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Paralysis