Clinical Trial: Feasibility of mindBEAGLE in Disorders of Consciousness or Locked-In Syndrome
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: 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:
- 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);
- To determine if mindBEAGLE neurophysiologic markers of cognitive function correlate with bedside behavioral assessments of consciousness;
- To determine if mindBEAGLE neurophysiologic markers of cognitive function correlate with functional MRI (fMRI) and electroencephalography (EEG) biomarkers of consciousness;
- To determine if mindBEAGLE can serve as an assistive communication device for people with LIS.
Detailed Summary:
Sponsor: Massachusetts General Hospital
Current Primary Outcome: Behavioral Diagnosis of Level of Consciousness (LoC) [ Time Frame: on the day of intervention ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- 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)
Original Secondary Outcome: Same as current
Information By: Massachusetts General Hospital
Dates:
Date Received: March 30, 2016
Date Started: March 2016
Date Completion: March 2019
Last Updated: May 11, 2016
Last Verified: May 2016