A Clinical Demonstration of EEG Brain-computer Interface for ALS Patients
Condition: ALS (Amyotrophic Lateral Sclerosis)
MeSH terms: Motor Neuron Disease; Amyotrophic Lateral Sclerosis; Sclerosis
Study type: Observational

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.
    

Intervention name(s): BCI Device
Intervention type(s): Device
Intervention description(s): A Brain Computer interface or BCI records brain signals and analyzes them to derive device commands. BCIs give their users communication and control channels that do not depend on peripheral nerves and muscles.
Other intervention name(s): Brain Computer Interface Device (BCI)
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).
      
Keywords: Amyotrophic Lateral Sclerosis; Brain Computer Interface (BCI); Lou Gehrig's disease