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

Consciousness Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02772302
• Other study ID #: 2015P002731
• Status: Completed
• Phase: N/A
• Start date: March 1, 2016
• Est. completion date: December 17, 2019

Study information

• Verified date: June 2021
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 17, 2019
• Est. primary completion date: December 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Consciousness Disorders
• Locked-In Syndrome
• Quadriplegia
• Syndrome

Intervention

Device:
• mindBEAGLE EEG-based brain-computer interface

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	on the day of intervention

External Links

•   Feasibility of an EEG-based brain-computer interface in the intensive care unit