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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02772302
Other study ID # 2015P002731
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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