Cooperative Studies Program (CSP) #567 - A Clinical Demonstration of EEG Brain-computer Interface for ALS Patients

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.