Status:
COMPLETED
A Clinical Demonstration of EEG Brain-computer Interface for ALS Patients
Lead Sponsor:
US Department of Veterans Affairs
Collaborating Sponsors:
New York State Department of Health
Conditions:
ALS (Amyotrophic Lateral Sclerosis)
Eligibility:
All Genders
18-79 years
Brief Summary
The goal of this VA demonstration project is to show that the Brain-computer interface (BCI) technology is a clinically practical and important new communication and control option that can improve th...
Detailed Description
People affected by severe motor disorders such as amyotrophic lateral sclerosis (ALS) need alternative methods for communication and control. They may not be able to use even the most basic convention...
Eligibility Criteria
Inclusion
- Inclusion and Exclusion Criteria
- Subject will be a veteran with El Escorial "Lab Supported Probable" or more definite diagnosis of ALS.
- Subject will have lost the ability to communicate either verbally or in writing (item 1 or item 4 on the ALS Functional Rating Scale-Revised (ALSFRS-R) score of 0, Appendix A) .
- Subject will be an adult (age \>18).
- Subject will be living at home.
- Subject will be living within 100 miles of the participating study site.
- Subject will have corrected visual acuity of at least 20/80.
- Subject will have the ability to read and understand 6th grade English text on a computer screen.
- Subject will be able to indicate willingness and understanding of the consent form (using their existing method of communication).
- Subject will be able to identify one significant other.
- Subject will identify one system operator (person that agrees to be trained and set up the BCI). This person can be the significant other.
- Subject will be able to communicate non-verbally with their significant other, caregiver and system operator, and with study personnel.
- Significant other, caregiver and system operator will be able to indicate willingness and understanding of the consent form, be adults (age\> 18) and expect to be with the subject for at least one year.
- Subject, significant other, caregiver and system operator will have life expectancy of at least one year.
- In the opinion of the BCI installation team, the home environment is physically and technologically conducive to BCI operation and use.
- Subject will demonstrate during the screening phase sufficient EEG interaction for the BCI to operate, i.e. classification rate of 70%. Classification rate is defined as the proportion of correct selections made during the daily calibration period of "copy spelling." Copy spelling data refers to data collected while the patient attends to and selects specific predefined characters.
- Significant other, caregiver and system operator will demonstrate during the screening phase sufficient skill to manage the daily set-up and routine operations needed for the subject's basic operation of the BCI.
Exclusion
Key Trial Info
Start Date :
September 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 1 2014
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT00786032
Start Date
September 1 2011
End Date
August 1 2014
Last Update
January 8 2015
Active Locations (5)
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1
VA Connecticut Healthcare System West Haven Campus, West Haven, CT
West Haven, Connecticut, United States, 06516
2
Albany VA Medical Center Samuel S. Stratton, Albany, NY
Albany, New York, United States, 12208
3
Durham VA Medical Center, Durham, NC
Durham, North Carolina, United States, 27705
4
VA Medical Center, Cleveland
Cleveland, Ohio, United States, 44106