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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Consciousness Disorders Locked-In Syndrome Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Neuromuscular Diseases Paralysis Pathological Conditions, Signs and Symptoms Quadriplegia Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

mindBEAGLE EEG-based brain-computer interface

Device

Primary outcomes

Behavioral Diagnosis of Level of Consciousness (LoC)

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Official study title

Feasibility Study of the mindBEAGLE Device in Patients With Disorders of Consciousness or Locked-In Syndrome

Important dates

Study start: 2016
Primary completion: 2019
Study completion: 2019
First posted: May 13, 2016
Registry last updated: Jun 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed