Abstract
It is necessary for patients, caregivers, and health care professionals to share the information of patients’ symptoms and patient-reported outcomes (PROs) to control their symptoms and maintain the function of affected organs. Speech, writing, and keyboard inputs become gradually impractical for patients with a variety of incurable and progressive neuro-muscular diseases, including amyotrophic lateral sclerosis (ALS). At present, when patients would like to express their thoughts and wishes, they are supported by “communication carers” using a transparent character board and a mouth-shape character method. They may also use communication devices operated with existing switches, which include contact, capacitive, photoelectric, breath, air-bag piezoelectric, and eye-tracking types. However, patients gradually become unable to manipulate any type of switch as their disease progresses. The development of a new interface device, which patients can use despite an inability to intentionally move their body parts, is now in demand. The mechanism of a newly developed device, termed the "Cybernic Interface, CyinTM", is based on Cybernics, a form of technology used in the cyborg-type robot Hybrid Assistive Limb. Our research group tested the usefulness and adverse events related to using its investigational device model, a Cybernic Interface AI02, in the clinical trial (JMACCTID: JMA-IIA00280). Fifteen patients with incurable and progressive neuromuscular diseases (12 with ALS and 3 with Duchenne Muscular Dystrophy) could successfully use AI02. A full clinical study report will be published elsewhere in the future. The cost of communication devices containing a Cybernic Interface, CyinTM may be reimbursed as a “grant for prosthetic devices” according to the Services and Supports for Persons with Disabilities Act.
