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An Osaka University research team is ready to clinically test a method allowing amyotrophic lateral sclerosis (ALS) patients to "type" messages with their mind, via small electroencephalographs (EEG) implanted in their heads.

ALS is an intractable disease that causes gradual loss of muscle movement throughout the body, eventually making it impossible to communicate even though the patient has a clear idea of what they want to say. The researchers hope the implant will allow patients to "speak" even if they cannot move. If approved, a six-month clinical trial will begin as early as this year with a small group of subjects.

Technology called a brain-machine interface (BMI) that handles the input and output from the subject's brain has been attracting attention in recent years for its potential application in medicine and business.

There are already machines to read the brain signals of ALS patients, but all of them do so from outside the body. The Osaka University clinical trial would be the first in Japan to use an implantable device to make more precise measurements to be fed to the BMI.

According to Masayuki Hirata, specially appointed professor of brain function diagnosis and reconstruction at Osaka University, the EEG implant is about 3 centimeters by 4 centimeters. A portion of the skull is surgically removed and electrodes are placed on the surface of the brain. The EEG measures high-frequency brain waves emitted from the brain's motor cortex when the body is about to move, and transmits them wirelessly to an AI-equipped computer outside the body.

In the trial, patients with the EEG implant will be asked to imagine holding hands, and the AI will pick up and learn the brain wave patterns associated with that action, allowing it to tell whether the patient is trying to hold hands.

For text input, the researchers will set up a device displaying Japan's phonetic hiragana syllabary, made up of 50 characters starting with "a". When the device's selector lands on the desired character, the patient can think about holding hands to pick that character. This is transmitted wirelessly via the EEG to the BMI device, allowing the patient to compose text. The EEG itself is wirelessly powered by a headphone-like device worn by the patient.

The researchers will first monitor patients using the system for six months, and if the patients wish, the researchers will set them up with the system at home. The team believes patients will be able to use the system for about five years, and that in the future it could be used to operate computers or electric wheelchairs.

ALS is a disease affecting the nerves in the brain that control movement, and there is no known treatment to improve patients' conditions. Those with advanced ALS communicate through slight muscle or eye movements.

There are some 10,000 ALS patients in Japan who have difficulty in daily life. As the disease progresses, patients may reach a state of total loss of function, in which they are conscious and able to think, but are unable to move any muscles, including their eyes, and are thus unable to communicate.

As symptoms worsen, breathing becomes difficult, and the patient must often decide whether to have a tracheotomy and be fitted with a ventilator. Although life expectancy is shorter without a ventilator, about 70% of patients choose not to use one out of concerns about becoming totally locked-in and the burden this will mean for family members caring for them. According to the Japan ALS Association, over 10% of all patients on ventilators are believed to be totally locked in.

The Osaka University team foresees getting consent from their clinical trial subjects before total loss of function. Hirata told the Mainichi Shimbun, "Many patients say they will not use a ventilator because they are worried about becoming totally locked in. But we know from patient surveys that some would change their decision if they use a BMI.

"We believe that this is a very significant technology that will change people's life and death choices," he added.

(Japanese original by Tomohiro Ikeda, Science and Environment News Department)

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