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

Mass General Brigham

Status: Completed

Conditions: Locked-In Syndrome; Consciousness Disorders

Treatments: Device: mindBEAGLE EEG-based brain-computer interface

Study type: Interventional

Funder types: Other

Identifiers

NCT02772302

2015P002731

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts 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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Patients

Experimental group

Description:

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

Treatment:

Device: mindBEAGLE EEG-based brain-computer interface

Healthy Controls

Experimental group

Description:

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

Treatment:

Device: mindBEAGLE EEG-based brain-computer interface