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

Not Applicable

Completed

• Conditions: Locked-In Syndrome; Consciousness Disorders
• Interventions: Device: mindBEAGLE EEG-based brain-computer interface

• Registration Number: NCT02772302
• Lead Sponsor: Massachusetts General Hospital

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.

Study Timeline

• Study Start: 2016-03-01
• Study First Submitted: 2016-03-30
• Study First Submitted QC: 2016-05-11
• Study First Posted: 2016-05-13
• Primary Completion: 2019-12-01
• Study Completion: 2019-12-17
• Results First Submitted: 2021-03-10
• Results First Submitted QC: 2021-04-06
• Results First Posted: 2021-04-30
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-02
• Last Update Posted: 2021-06-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patients	mindBEAGLE EEG-based brain-computer interface	Application of bedside, EEG-based mindBEAGLE Brain-Computer Interface
Healthy Controls	mindBEAGLE EEG-based brain-computer interface	Application of bedside, EEG-based mindBEAGLE Brain-Computer Interface

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States