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Feasibility of mindBEAGLE in Disorders of Consciousness or Locked-In Syndrome

Primary Purpose

Consciousness Disorders, Locked-In Syndrome

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
mindBEAGLE EEG-based brain-computer interface
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Consciousness Disorders

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Massachusetts General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Patients

Healthy Controls

Arm Description

Application of bedside, EEG-based mindBEAGLE Brain-Computer Interface

Application of bedside, EEG-based mindBEAGLE Brain-Computer Interface

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
March 30, 2016
Last Updated
June 2, 2021
Sponsor
Massachusetts General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02772302
Brief Title
Feasibility of mindBEAGLE in Disorders of Consciousness or Locked-In Syndrome
Official Title
Feasibility Study of the mindBEAGLE Device in Patients With Disorders of Consciousness or Locked-In Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
March 1, 2016 (Actual)
Primary Completion Date
December 1, 2019 (Actual)
Study Completion Date
December 17, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 Description
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; To determine if mindBEAGLE neurophysiologic markers of cognitive function correlate with bedside behavioral assessments of consciousness; To determine if mindBEAGLE can serve as an assistive communication device for people with LIS.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Consciousness Disorders, Locked-In Syndrome

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Arm 1: patients Arm 2: healthy controls
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patients
Arm Type
Experimental
Arm Description
Application of bedside, EEG-based mindBEAGLE Brain-Computer Interface
Arm Title
Healthy Controls
Arm Type
Experimental
Arm Description
Application of bedside, EEG-based mindBEAGLE Brain-Computer Interface
Intervention Type
Device
Intervention Name(s)
mindBEAGLE EEG-based brain-computer interface
Primary Outcome Measure Information:
Title
Behavioral Diagnosis of Level of Consciousness (LoC)
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brian L. Edlow, M.D.
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States

12. IPD Sharing Statement

Links:
URL
https://pubmed.ncbi.nlm.nih.gov/29804044/
Description
Feasibility of an EEG-based brain-computer interface in the intensive care unit

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Feasibility of mindBEAGLE in Disorders of Consciousness or Locked-In Syndrome

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