| Study summary: |
|
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. |
| Criteria: |
|
Inclusion Criteria:
- El Escorial "Lab Supported Probable" or more definite diagnosis of ALS.
- Subject has lost the ability to communicate verbally (Score of 0 on Item #1 of the
ALSFRS-R).
Exclusion Criteria:
- Non-veteran.
- Subject is unable to communicate with caregiver and study personnel willingness and
understanding of the consent form (using their existing method of communication).
- Subject is unable to communicate non-verbally with their significant other and
systems operator, or with study personnel.
- Subject is unable to identify one significant other.
- Subject is unable to identify one systems operator (person that agrees to be trained
and set up the BCI). This person can be the significant other.
- Significant other and systems operator are unable to indicate willingness and
understanding of the consent form, age <18, and do not expect to be with the subject
for at least one year.
- Visual acuity uncorrectable to at least 20/80.
- Unable to read and comprehend 6th grade text on a computer screen.
- Subject is not living at home.
- Subject's residence is greater than 100 miles from the participating site.
- Subjects age <18.
- Subject, significant other or systems operator do not have a life expectancy of at
least one year.
- In the opinion of the BCI installation team, the home environment is not physically
and technologically conducive to the BCI operation and use.
- Subject is unable to 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 subject attends to and selects specific predefined characters.
- Significant other and systems operator are unable to 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. |