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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

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Conditions Consciousness Disorders
Locked-In Syndrome
Intervention Device: mindBEAGLE EEG-based brain-computer interface
Enrollment 20
Recruitment Details  
Pre-assignment Details  
Arm/Group Title mindBEAGLE Healthy Controls
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Application of bedside, EEG-based mindBEAGLE Brain-Computer Interface

mindBEAGLE EEG-based brain-computer interface

healthy subjects with no history of neurological disease
Period Title: Overall Study
Started 10 10
Completed 10 10
Not Completed 0 0
Arm/Group Title mindBEAGLE (Inpatient Participants) mindBEAGLE (Healthy Controls) Total
Hide Arm/Group Description

Application of bedside, EEG-based mindBEAGLE Brain-Computer Interface

mindBEAGLE EEG-based brain-computer interface

Application of bedside, EEG-based mindBEAGLE Brain-Computer Interface tested in healthy controls to provide baseline validation of the technology. Total of all reporting groups
Overall Number of Baseline Participants 10 10 20
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 10 participants 20 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
7
  70.0%
9
  90.0%
16
  80.0%
>=65 years
3
  30.0%
1
  10.0%
4
  20.0%
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 10 participants 10 participants 20 participants
56
(37 to 72)
34
(20 to 70)
41
(20 to 72)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 10 participants 20 participants
Female
2
  20.0%
4
  40.0%
6
  30.0%
Male
8
  80.0%
6
  60.0%
14
  70.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 10 participants 20 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
3
  30.0%
3
  30.0%
6
  30.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
1
  10.0%
0
   0.0%
1
   5.0%
White
4
  40.0%
5
  50.0%
9
  45.0%
More than one race
0
   0.0%
1
  10.0%
1
   5.0%
Unknown or Not Reported
2
  20.0%
1
  10.0%
3
  15.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 10 participants 10 participants 20 participants
10 10 20
1.Primary Outcome
Title Behavioral Diagnosis of Level of Consciousness (LoC)
Hide Description 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.
Time Frame on the day of intervention
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Hide Analysis Population Description
patients in the ICU (n=10) and healthy control subjects (n=10)
Arm/Group Title mindBEAGLE Healthy Control Subjects
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Application of bedside, EEG-based mindBEAGLE Brain-Computer Interface

mindBEAGLE EEG-based brain-computer interface

Application of bedside, EEG-based mindBEAGLE Brain-Computer Interface mindBEAGLE EEG-based brain-computer interface
Overall Number of Participants Analyzed 10 10
Measure Type: Number
Unit of Measure: score on a scale
patient 1 0 23
patient 2 2 23
patient 3 2 23
patient 4 2 23
patient 5 5 23
patient 6 3 23
patient 7 10 23
patient 8 13 23
patient 9 16 23
patient 10 16 23
Time Frame During mindBEAGLE assessment in the intensive care unit, which lasted up to 4 hours.
Adverse Event Reporting Description Participants with Disorders of Consciousness or Locked in Syndrome were enrolled in the Neuro-ICU where adverse events, related or unrelated to the intervention/device were systematically monitored through regular investigator assessment and regular laboratory testing.
 
Arm/Group Title mindBEAGLE Healthy Controls
Hide Arm/Group Description

Application of bedside, EEG-based mindBEAGLE Brain-Computer Interface

mindBEAGLE EEG-based brain-computer interface

healthy subjects with no history of neurological disease
All-Cause Mortality
mindBEAGLE Healthy Controls
Affected / at Risk (%) Affected / at Risk (%)
Total   0/10 (0.00%)   0/10 (0.00%) 
Hide Serious Adverse Events
mindBEAGLE Healthy Controls
Affected / at Risk (%) Affected / at Risk (%)
Total   1/10 (10.00%)   0/10 (0.00%) 
General disorders     
Hypotension  [1]  1/10 (10.00%)  /10 
Indicates events were collected by systematic assessment
[1]
One serious, unexpected and unrelated adverse event was experienced, related to hypotension requiring IV fluid administration during EEG.
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
mindBEAGLE Healthy Controls
Affected / at Risk (%) Affected / at Risk (%)
Total   0/10 (0.00%)   0/10 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Brian Edlow
Organization: Massachusetts General Hospital
Phone: 6177246352
EMail: bedlow@mgh.harvard.edu
Layout table for additonal information
Responsible Party: Brian L. Edlow, M.D., Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT02772302    
Other Study ID Numbers: 2015P002731
First Submitted: March 30, 2016
First Posted: May 13, 2016
Results First Submitted: March 10, 2021
Results First Posted: April 30, 2021
Last Update Posted: June 3, 2021