Consciousness Disorders, Locked-In Syndrome
Conditions
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.
Interventions
DEVICEmindBEAGLE EEG-based brain-computer interface
Sponsors
Massachusetts General Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
Arm 1: patients Arm 2: healthy controls
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Behavioral Diagnosis of Level of Consciousness (LoC) | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| mindBEAGLE (Inpatient Participants) Application of bedside, EEG-based mindBEAGLE Brain-Computer Interface
mindBEAGLE EEG-based brain-computer interface | 10 |
| mindBEAGLE (Healthy Controls) Application of bedside, EEG-based mindBEAGLE Brain-Computer Interface tested in healthy controls to provide baseline validation of the technology. | 10 |
| Total | 20 |
Baseline characteristics
| Characteristic | mindBEAGLE (Healthy Controls) | Total | mindBEAGLE (Inpatient Participants) |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 4 Participants | 3 Participants |
| Age, Categorical Between 18 and 65 years | 9 Participants | 16 Participants | 7 Participants |
| Age, Continuous | 34 years | 41 years | 56 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 6 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 3 Participants | 2 Participants |
| Race (NIH/OMB) White | 5 Participants | 9 Participants | 4 Participants |
| Region of Enrollment United States | 10 participants | 20 participants | 10 participants |
| Sex: Female, Male Female | 4 Participants | 6 Participants | 2 Participants |
| Sex: Female, Male Male | 6 Participants | 14 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 10 |
| other Total, other adverse events | 0 / 10 | 0 / 10 |
| serious Total, serious adverse events | 1 / 10 | 0 / 10 |
Outcome results
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.
Time frame: on the day of intervention
Population: patients in the ICU (n=10) and healthy control subjects (n=10)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| mindBEAGLE | Behavioral Diagnosis of Level of Consciousness (LoC) | patient 6 | 3 score on a scale |
| mindBEAGLE | Behavioral Diagnosis of Level of Consciousness (LoC) | patient 3 | 2 score on a scale |
| mindBEAGLE | Behavioral Diagnosis of Level of Consciousness (LoC) | patient 7 | 10 score on a scale |
| mindBEAGLE | Behavioral Diagnosis of Level of Consciousness (LoC) | patient 2 | 2 score on a scale |
| mindBEAGLE | Behavioral Diagnosis of Level of Consciousness (LoC) | patient 8 | 13 score on a scale |
| mindBEAGLE | Behavioral Diagnosis of Level of Consciousness (LoC) | patient 4 | 2 score on a scale |
| mindBEAGLE | Behavioral Diagnosis of Level of Consciousness (LoC) | patient 9 | 16 score on a scale |
| mindBEAGLE | Behavioral Diagnosis of Level of Consciousness (LoC) | patient 5 | 5 score on a scale |
| mindBEAGLE | Behavioral Diagnosis of Level of Consciousness (LoC) | patient 10 | 16 score on a scale |
| mindBEAGLE | Behavioral Diagnosis of Level of Consciousness (LoC) | patient 1 | 0 score on a scale |
| Healthy Control Subjects | Behavioral Diagnosis of Level of Consciousness (LoC) | patient 10 | 23 score on a scale |
| Healthy Control Subjects | Behavioral Diagnosis of Level of Consciousness (LoC) | patient 1 | 23 score on a scale |
| Healthy Control Subjects | Behavioral Diagnosis of Level of Consciousness (LoC) | patient 2 | 23 score on a scale |
| Healthy Control Subjects | Behavioral Diagnosis of Level of Consciousness (LoC) | patient 3 | 23 score on a scale |
| Healthy Control Subjects | Behavioral Diagnosis of Level of Consciousness (LoC) | patient 5 | 23 score on a scale |
| Healthy Control Subjects | Behavioral Diagnosis of Level of Consciousness (LoC) | patient 6 | 23 score on a scale |
| Healthy Control Subjects | Behavioral Diagnosis of Level of Consciousness (LoC) | patient 7 | 23 score on a scale |
| Healthy Control Subjects | Behavioral Diagnosis of Level of Consciousness (LoC) | patient 8 | 23 score on a scale |
| Healthy Control Subjects | Behavioral Diagnosis of Level of Consciousness (LoC) | patient 9 | 23 score on a scale |
| Healthy Control Subjects | Behavioral Diagnosis of Level of Consciousness (LoC) | patient 4 | 23 score on a scale |