Complete Locked-in State Clinical Trial
Official title:
Brain Computer Interface Based Communication in the Completely Locked-In State
Electroencephalography (EEG) and/or near-infrared spectroscopy (NIRS) based Brain computer interface for communication in patients without any means of communication.
Amyotrophic lateral sclerosis is a progressive motor disease of unknown etiology resulting
eventually in a complete paralysis of the motor system but affecting sensory or cognitive
functions to a minor degree. There is no treatment available; patients have to decide to
accept artificial respiration and feeding after the disease destroys respiratory and bulbar
functions or to die of respiratory or related problems. If they opt for life and accept
artificial respiration, the disease progresses until the patient loses control of the last
muscular response, usually the eye muscles. If rudimentary voluntary control of at least one
muscle is present the syndrome is called locked-in state (LIS); ultimately as the disease
progresses most ALS patients lose the control of all muscles, the resulting condition is
called completely locked-in state (CLIS). Patients in CLIS are unable to communicate with the
external world because all assistive communication aids are based on some remaining motor
control; hence there is a vital need for an assistive technology to help patients in CLIS to
communicate needs and feelings to their family members/caregivers. Brain computer interface
(BCI) represents a promising strategy to establish communication with paralyzed ALS patients,
as it does not need muscle control. BCI research includes invasive (implantable electrodes on
or in the neocortex) and noninvasive means (including electroencephalography (EEG),
magnetoencephalography (MEG), functional magnetic resonance imaging (fMRI), and near-infrared
spectroscopy (NIRS)) to record brain activity for conveying the user's intent to devices such
as simple word-processing programs. Non-invasive methods have been utilized more frequently
than invasive methods for people with disabilities (such as those with ALS).
For these conditions (LIS and CLIS) Brain-Computer-Interface were developed and tested
extensively since the first publication of Birbaumer, 1999 of two LIS patients suffering from
ALS. Patients select letters or words after learning self-regulation of the particular brain
signal or by focusing their attention to the desired letter or a letter-matrix and the
attention related brain potential selects the desired letter.
Different types of BCI based on EEG and/NIRS is under development to provide a means of
communication to patients who have none.
;