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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
Results First Posted : April 30, 2021
Last Update Posted : June 3, 2021
Sponsor:
Information provided by (Responsible Party):
Brian L. Edlow, M.D., Massachusetts General Hospital

Tracking Information
First Submitted Date  ICMJE March 30, 2016
First Posted Date  ICMJE May 13, 2016
Results First Submitted Date  ICMJE March 10, 2021
Results First Posted Date  ICMJE April 30, 2021
Last Update Posted Date June 3, 2021
Actual Study Start Date  ICMJE March 1, 2016
Actual Primary Completion Date December 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 6, 2021)
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). Higher scores are generally associated with a higher level of consciousness.
Original Primary Outcome Measures  ICMJE
 (submitted: May 11, 2016)
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)
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: May 11, 2016)
  • 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)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Feasibility of mindBEAGLE in Disorders of Consciousness or Locked-In Syndrome
Official Title  ICMJE Feasibility Study of the mindBEAGLE Device in Patients With Disorders of Consciousness or Locked-In Syndrome
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.
Detailed Description
  1. To determine the feasibility of deploying mindBEAGLE, a portable, bedside EEG-based system, in the Neurosciences Intensive Care Unit in patients with DOC or LIS;
  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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Arm 1: patients Arm 2: healthy controls
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Consciousness Disorders
  • Locked-In Syndrome
Intervention  ICMJE Device: mindBEAGLE EEG-based brain-computer interface
Study Arms  ICMJE
  • Experimental: Patients
    Application of bedside, EEG-based mindBEAGLE Brain-Computer Interface
    Intervention: Device: mindBEAGLE EEG-based brain-computer interface
  • Experimental: Healthy Controls
    Application of bedside, EEG-based mindBEAGLE Brain-Computer Interface
    Intervention: Device: mindBEAGLE EEG-based brain-computer interface
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 6, 2021)
20
Original Estimated Enrollment  ICMJE
 (submitted: May 11, 2016)
10
Actual Study Completion Date  ICMJE December 17, 2019
Actual Primary Completion Date December 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02772302
Other Study ID Numbers  ICMJE 2015P002731
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Brian L. Edlow, M.D., Massachusetts General Hospital
Study Sponsor  ICMJE Massachusetts General Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Brian L. Edlow, M.D. Massachusetts General Hospital
PRS Account Massachusetts General Hospital
Verification Date June 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP