Feasibility of mindBEAGLE in Disorders of Consciousness or Locked-In Syndrome
Purpose
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.
Conditions
- Consciousness Disorders
- Locked-In Syndrome
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts 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
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Non-Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- Arm 1: patients Arm 2: healthy controls
- Primary Purpose
- Diagnostic
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Patients |
Application of bedside, EEG-based mindBEAGLE Brain-Computer Interface |
|
|
Experimental Healthy Controls |
Application of bedside, EEG-based mindBEAGLE Brain-Computer Interface |
|
More Details
- Status
- Completed
- Sponsor
- Massachusetts General Hospital
Study Contact
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.