A Clinical Demonstration of EEG Brain-computer Interface for ALS Patients
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.
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.
Study Design
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Conditions
ALS (Amyotrophic Lateral Sclerosis)
Intervention
Brain Computer Interface (BCI)
Location
VA Medical Center, Cleveland
Cleveland
Ohio
United States
44106
Status
Not yet recruiting
Source
Department of Veterans Affairs
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00786032
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Riluzole
A glutamate antagonist (RECEPTORS, GLUTAMATE) used as an anticonvulsant (ANTICONVULSANTS) and to prolong the survival of patients with AMYOTROPHIC LATERAL SCLEROSIS.
Tdp-43 Proteinopathies
Diseases characterized by the presence of abnormally phosphorylated, ubiquitinated, and cleaved DNA-binding protein TDP-43 in affected brain and spinal cord. Inclusions of the pathologic protein in neurons and glia, without the presence of AMYLOID, is the major feature of these conditions, thus making these proteinopathies distinct from most other neurogenerative disorders in which protein misfolding leads to brain amyloidosis. Both frontotemporal lobar degeneration and AMYOTROPHIC LATERAL SCLEROSIS exhibit this common method of pathogenesis and thus they may represent two extremes of a continuous clinicopathological spectrum of one disease.
Amyotrophic Lateral Sclerosis
A degenerative disorder affecting upper MOTOR NEURONS in the brain and lower motor neurons in the brain stem and SPINAL CORD. Disease onset is usually after the age of 50 and the process is usually fatal within 3 to 6 years. Clinical manifestations include progressive weakness, atrophy, FASCICULATION, hyperreflexia, DYSARTHRIA, dysphagia, and eventual paralysis of respiratory function. Pathologic features include the replacement of motor neurons with fibrous ASTROCYTES and atrophy of anterior SPINAL NERVE ROOTS and corticospinal tracts. (From Adams et al., Principles of Neurology, 6th ed, pp1089-94)
Motor Neuron Disease
Diseases characterized by a selective degeneration of the motor neurons of the spinal cord, brainstem, or motor cortex. Clinical subtypes are distinguished by the major site of degeneration. In AMYOTROPHIC LATERAL SCLEROSIS there is involvement of upper, lower, and brainstem motor neurons. In progressive muscular atrophy and related syndromes (see MUSCULAR ATROPHY, SPINAL) the motor neurons in the spinal cord are primarily affected. With progressive bulbar palsy (BULBAR PALSY, PROGRESSIVE), the initial degeneration occurs in the brainstem. In primary lateral sclerosis, the cortical neurons are affected in isolation. (Adams et al., Principles of Neurology, 6th ed, p1089)
Bulbar Palsy, Progressive
A motor neuron disease marked by progressive weakness of the muscles innervated by cranial nerves of the lower brain stem. Clinical manifestations include dysarthria, dysphagia, facial weakness, tongue weakness, and fasciculations of the tongue and facial muscles. The adult form of the disease is marked initially by bulbar weakness which progresses to involve motor neurons throughout the neuroaxis. Eventually this condition may become indistinguishable from AMYOTROPHIC LATERAL SCLEROSIS. Fazio-Londe syndrome is an inherited form of this illness which occurs in children and young adults. (Adams et al., Principles of Neurology, 6th ed, p1091; Brain 1992 Dec;115(Pt 6):1889-1900)
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