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The primary aims of this study are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients | Experimental | Application of bedside, EEG-based mindBEAGLE Brain-Computer Interface |
|
| Healthy Controls | Experimental | Application of bedside, EEG-based mindBEAGLE Brain-Computer Interface |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mindBEAGLE EEG-based brain-computer interface | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Behavioral Diagnosis of Level of Consciousness (LoC) | 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. | on the day of intervention |
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Inclusion Criteria:
Exclusion Criteria:
• History of developmental, neurologic, or major psychiatric disorder resulting in functional disability
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| Name | Affiliation | Role |
|---|---|---|
| Brian L. Edlow, M.D. | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
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| Label | URL |
|---|---|
| Feasibility of an EEG-based brain-computer interface in the intensive care unit | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | mindBEAGLE | Application of bedside, EEG-based mindBEAGLE Brain-Computer Interface mindBEAGLE EEG-based brain-computer interface |
| FG001 | Healthy Controls | healthy subjects with no history of neurological disease |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | mindBEAGLE (Inpatient Participants) | Application of bedside, EEG-based mindBEAGLE Brain-Computer Interface mindBEAGLE EEG-based brain-computer interface |
| BG001 | mindBEAGLE (Healthy Controls) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Behavioral Diagnosis of Level of Consciousness (LoC) | 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. | patients in the ICU (n=10) and healthy control subjects (n=10) | Posted | Number | score on a scale | on the day of intervention |
|
During mindBEAGLE assessment in the intensive care unit, which lasted up to 4 hours.
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | mindBEAGLE | Application of bedside, EEG-based mindBEAGLE Brain-Computer Interface mindBEAGLE EEG-based brain-computer interface |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypotension | General disorders | Systematic Assessment | One serious, unexpected and unrelated adverse event was experienced, related to hypotension requiring IV fluid administration during EEG. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Brian Edlow | Massachusetts General Hospital | 6177246352 | bedlow@mgh.harvard.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 27, 2018 | Apr 6, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003244 | Consciousness Disorders |
| D000080422 | Locked-In Syndrome |
| ID | Term |
|---|---|
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
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Arm 1: patients Arm 2: healthy controls
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Application of bedside, EEG-based mindBEAGLE Brain-Computer Interface tested in healthy controls to provide baseline validation of the technology.
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Median | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| 0 |
| 10 |
| 1 |
| 10 |
| 0 |
| 10 |
| EG001 | Healthy Controls | healthy subjects with no history of neurological disease | 0 | 10 | 0 | 10 | 0 | 10 |
|
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| D013568 | Pathological Conditions, Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D011782 | Quadriplegia |
| D010243 | Paralysis |
| D009468 | Neuromuscular Diseases |