Clinical trial NCT00786032: A Clinical Demonstration of EEG Brain-computer Interface for ALS Patients
Official title: Cooperative Studies Program (CSP) #567 - A Clinical Demonstration of EEG Brain-computer Interface for ALS Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: ALS (Amyotrophic Lateral Sclerosis)
Keywords: Amyotrophic Lateral Sclerosis
Brain Computer Interface (BCI)
Lou Gehrig's disease
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
Collaborators: name: New York State Department of Health
First posted: 2008-11-05
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The subjects were patients at five VA medical centers who were severely disabled by amyotrophic lateral sclerosis (ALS).

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 the lives of veterans with amyotrophic lateral sclerosis (ALS). The project will test four well-supported hypotheses: (1) that people with ALS who find (or will soon find) conventional assistive technology inadequate can and will use a BCI system for important purposes in their daily lives without close technical oversight, 2) they will continue and even increase this use throughout the period of the study, (3) that BCI use will improve their lives, and 4) BCI will improve the lives of their families and caregivers.

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 conventional assistive technologies, which all rely in one way or another on muscles. For these people, communication and control technology that does not depend on neuromuscular function is essential. Brain-computer interfaces (BCIs) can give these individuals communication and control capacity that does not depend on nerves and muscles. It has been shown that even people who are almost completely paralyzed can control sensor motor rhythms and other features of scalp-recorded electroencephalographic (EEG) activity and that they can use this control to move a computer cursor in one or two dimensions, to select letters or icons, or even to move a robotic arm. The group is now focused on developing clinically practical BCI applications, translating them from the laboratory into people's homes, and establishing that they can have a positive impact on the lives of people with severe disabilities.

The goal of this VA demonstration project is to show that BCI technology is a clinically practical and important new communication and control option that can improve the lives of veterans with amyotrophic lateral sclerosis (ALS). The project will test four well-supported hypotheses: (1) that people with ALS who find (or will soon find) conventional assistive technology inadequate can and will use a BCI system for important purposes in their daily lives without close technical oversight, 2) they will continue and even increase this use throughout the period of the study, (3) that BCI use will improve their lives, and 4) BCI will improve the lives of their families and caregivers.

In accord with these hypotheses, the aims are:

Aim 1: To recruit 2-4 person teams of VA health professionals (e.g., physicians, nurses, nurse- practitioners, physician's assistants, EEG technicians, therapists, rehabilitation specialists, medical researchers) at each of 5-6 participating VA centers, and train them in the use and ongoing support of the BCI home system. These teams will use the VA ALS database, local ALS Association affiliates, and VA clinics to identify and recruit at each site 3-4 patients with ALS who are not adequately served by conventional assistive technology; have stable physical and social environments; and have caregivers with basic computer skills who are willing to support BCI use. The VA teams will set up BCI systems in the patients' homes and teach them and their caregivers how to use the system on a daily basis for applications that the individual patients desire, such as e-mail, environmental control, computer-mediated conversations, word-processing, and/or entertainment. The VA teams will provide long-distance Internet-based oversight as the patients begin to use BCI technology for communication and control in their daily lives. The Project teams will be available for onsite supervision at the beginning of BCI use and for periodic in-home evaluations later on. In addition to providing ongoing oversight and guidance of the project, the group will focus on reducing the need for continued expert support (both onsite and remote) by incorporating into the BCI software adaptations and adjustments that are essential for reliable operation and by further simplifying and streamlining the caregiver interface and other aspects of system operation. The ultimate goal is a practical system that can be used by many severely disabled people in their homes with minimal ongoing technical support.

Aim 2: To assess the extent and success of BCI usage and its impact on quality of life. Via the Internet link and periodic visits, the Project teams will quantify the amount of BCI usage in both absolute terms and in terms of its importance for supporting specific functions (e.g., interactions with family, e-mail); and will quantify BCI performance in terms of accuracy and speed. In addition, standard and specialized quality-of-life measures and BCI assessment questionnaires will be used to quantitatively evaluate the long-term impact of BCI technology on the lives of the users, their caregivers, and their families. The effects of disease progression (e.g., loss of remaining neuromuscular function) on the extent and nature of BCI use will also be monitored. We expect this work to establish that the communication and control applications provided by the BCI system are heavily used by people severely disabled by ALS, that the BCI can produce lasting improvement in their lives and in the lives of those close to them, and that the BCI can even allow people who would otherwise become totally locked-in to continue to interact with their families and friends.

The success of this project will depend on establishment and maintenance of reliable high-speed daily communication between the subjects, the VA sites, and the Project team. The VA and investigators must be able to evaluate each subject's EEG data every day, 7 days/week, so that questions can be answered, problems can be solved, and system parameters can be optimized within 24 hrs.

In this study, the first primary hypothesis is that the subjects will begin to use the BCI for important purposes in their daily lives and that they will continue and even increase this use throughout the period of the study. Thus, the primary quantitative outcomes for this hypothesis will be 1) the time spent using the BCI and 2) the change in this time over the study period. If their BCI use time is substantial and remains stable or increases over the study, we will be able to conclude that the subjects have found the BCI system desirable and valuable. The second primary hypothesis is that BCI will improve the quality of life of people severely disabled by ALS. Secondary outcomes include: caregiver quality of life measures; the patient and caregiver assessments of BCI usefulness; the BCI performance (i.e., speed and accuracy); and the amount of time spent by project staff in technical support.

The completion of this study and the achievement of its aims should help to move EEG based BCI technology out of the laboratory and to demonstrate that it is a powerful, clinically practical, and affordable communication and control technology that can substantially improve the lives of people with ALS. Furthermore, the study should validate and establish an important new option, BCI-based communication that the VA can provide to many of its most severely disabled patients. This achievement would make the VA the first and only entity in the world that can provide this radically new and important assistive technology to its patients.

Forty prospective BCI Users satisfied the inclusion criteria and provided informed consent\*. \[\*Footnote 1: Two additional people who provided informed consent were subsequently found to not satisfy the inclusion criteria.\] Thirty-seven completed the BCI assessment sessions, 28 satisfied the BCI accuracy criterion, and 27 had the BCI system placed in their homes.

Eligibility criteria: Inclusion and Exclusion Criteria

1. Subject will be a veteran with El Escorial "Lab Supported Probable" or more definite diagnosis of ALS.
2. 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) .
3. Subject will be an adult (age \>18).
4. Subject will be living at home.
5. Subject will be living within 100 miles of the participating study site.
6. Subject will have corrected visual acuity of at least 20/80.
7. Subject will have the ability to read and understand 6th grade English text on a computer screen.
8. Subject will be able to indicate willingness and understanding of the consent form (using their existing method of communication).
9. Subject will be able to identify one significant other.
10. Subject will identify one system operator (person that agrees to be trained and set up the BCI). This person can be the significant other.
11. Subject will be able to communicate non-verbally with their significant other, caregiver and system operator, and with study personnel.
12. 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.
13. Subject, significant other, caregiver and system operator will have life expectancy of at least one year.
14. In the opinion of the BCI installation team, the home environment is physically and technologically conducive to BCI operation and use.
15. 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.
16. 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.

Primary outcomes:
measure: BCI System Usage by the ALS Patient
timeFrame: Up to 18 months
measure: BCI System Usage by the ALS Patient
timeFrame: Up to 18 months
measure: BCI System Usage by the ALS Patient
timeFrame: Up to 18 months
measure: BCI System Usage by the ALS Patient
timeFrame: Up to 18 months
Secondary outcomes:
measure: BCI Usage by and Impact on the ALS Patient
timeFrame: Up to 18 months
measure: Time of BCI Impact on the Significant Other and Systems Operator
timeFrame: Up to 18 months
measure: Facility Support Speed of Solution
timeFrame: Up to 18 months
Other outcomes:
Locations:
city: West Haven
country: United States
facility: VA Connecticut Healthcare System West Haven Campus, West Haven, CT
state: Connecticut
city: Albany
country: United States
facility: Albany VA Medical Center Samuel S. Stratton, Albany, NY
state: New York
city: Durham
country: United States
facility: Durham VA Medical Center, Durham, NC
state: North Carolina
city: Cleveland
country: United States
facility: VA Medical Center, Cleveland
state: Ohio
city: Providence
country: United States
facility: Providence VA Medical Center, Providence, RI
state: Rhode Island
Study officials:
affiliation: VA Medical Center-Cleveland
name: Robert Ruff, MD PhD
role: STUDY_CHAIR
References: