Ignite Creation Date:
2025-12-25 @ 3:52 AM
Ignite Modification Date:
2026-03-01 @ 10:08 AM
Study NCT ID:
NCT02772302
Status:
COMPLETED
Last Update Posted:
2021-06-03
First Post:
2016-03-30
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Feasibility of mindBEAGLE in Disorders of Consciousness or Locked-In Syndrome
Sponsor:
Massachusetts General Hospital
Organization:
Study Overview
Official Title:
Feasibility Study of the mindBEAGLE Device in Patients With Disorders of Consciousness or Locked-In Syndrome
Status:
COMPLETED
Status Verified Date:
2021-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: