Patients with Locked-In Syndrome (LIS) are cognitively intact but unable to move or communicate except through eye blinks or limited (vertical) eye movements. For many patients suffering from this predicament, self-initiated communication is no longer possible, and they are unable to start a conversation, ask a question, or draw caregiver attention. Having no other means of interacting with family or friends, these LIS patients lack privacy and any degree of independence. Recently, a Brain-Computer Interface (BCI) device was successfully implanted in a locked-in patient with late stage ALS. By modulating her brain signals, this patient was able to select letters and spell words. The breakthrough was that, for the first time, a BCI system performed well enough to enable use at home without the need for experts. This was published in the New England Journal of Medicine. Yet, the rate of spelling was only 2 characters per minute, which clearly needs to be improved. In this collaborative early-feasibility study between the University Medical Center Utrecht (The Netherlands), the Johns Hopkins University (Baltimore), and the Neuromodulation Research unit of Medtronic (Minneapolis), we will use a significantly improved version of the implant device to develop faster and more versatile BCI control techniques for home use. The overall goal of the research is 1) to prove that the basic functionality of this BCI is generalizable to other patients with LIS (AIM1), and 2) to expand current BCI capabilities through research along 3 avenues aiming to achieve A) multidimensional item selection (avenue ?Multiselect?) that would allow patients to choose among multiple menu options, B) 2D cursor control (avenue ?Navigate?) that would allow point-and-click use of a computer, similar to that of eye trackers for users with normal eye movements, and C) vocalization through a speech synthesizer (avenue ?Speak?) (AIM2), which would greatly enhance communication and quality of life. A total of nine LIS patients will participate for one year each, during and after which they may continue to use the BCI system at home. An additional 16 patients with electrode grids implanted for unrelated diagnostic purposes (epilepsy surgery) will be included for the development of advanced decoding algorithms, utilizing clinical 256-channel recording systems. The study will demonstrate the feasibility of providing LIS patients with an alternative means of communication, thereby moving the current state of the art in human neuroscience to the realm of clinical treatment for severe communication disorders.

Public Health Relevance

A variety of neurological disorders may result in Locked-In Syndrome (LIS), in which paralysis severely restricts communication. Patients suffering from this predicament are unable to start a conversation, ask a question, or draw caregiver attention. Building on a recent demonstration in a patient with late-stage ALS, this project will recruit patients with LIS to use a fully implantable, wireless Brain-Computer Interface (BCI) device, to enhance their communication in a variety of ways. In these patients, and in patients implanted with electrodes for epilepsy surgery, we will study how this technology can be improved for future use in patients with LIS.

Agency
National Institute of Health (NIH)
Institute
National Institute on Deafness and Other Communication Disorders (NIDCD)
Type
Research Project--Cooperative Agreements (U01)
Project #
1U01DC016686-01
Application #
9440467
Study Section
Special Emphasis Panel (ZDC1)
Program Officer
Shekim, Lana O
Project Start
2018-09-01
Project End
2023-08-31
Budget Start
2018-09-01
Budget End
2019-08-31
Support Year
1
Fiscal Year
2018
Total Cost
Indirect Cost
Name
University Medical Center Utrecht
Department
Type
DUNS #
412934598
City
Utrecht
State
Country
Netherlands
Zip Code
3508 GA