A New Eye-based Communication Device for ALS Patients
Condition: Amyotrophic Lateral Sclerosis
MeSH terms: Motor Neuron Disease; Amyotrophic Lateral Sclerosis
Study type: Interventional

Summary: 
      Eighteen ALS patients will be trained to control a new communication device (Eye On Line:
      EOL) that permit over smooth eye movements to generate digits, letters, words or drawing at
      will. The intervention consists in a training program during six visits over 3 weeks on site
      allowing a gradual acquisition of the eye-writing. The primary objective of the study is to
      assess the feasibility of the use of EOL device in ALS patients. The EOL device potentially
      offers a creative and personal means of linguistic and emotional expression in subject with
      motor disability.
    

Detailed description: 
      Background: Motor weakness progression in ALS challenges communication modalities such as
      writing or speech with a marked impairment of quality of life. In recent years the
      development of appropriate communication tools played a key role to maintain patients in an
      efficient interaction with environment and caregivers. However there is a need for tools to
      customize communication and provide a creative space. Eye on-line (EOL) is a new
      communication device with which the user is presented with an illusion inducing visual
      stimulus resulting in the perception of illusory movement that can be followed by the eye, so
      that smooth pursuit eye movement can be sustained in arbitrary directions.(1) After an
      appropriate training participants gain volitional control over smooth eye movements and can
      generate digits, letters, words or drawing at will.

      Objectives: The primary objective of the study is to assess the feasibility of the use of EOL
      device in ALS patients. The secondary objective is to assess its clinical safety in subjects
      with ALS. We added exploratory objectives to evaluate eye movements in ALS patients, to study
      factors (neuropsychology, eye movements) that may influence the use of the apparatus and to
      evaluate a Bayesian computational model for online character recognition.(2) Methods:
      Eighteen subjects with ALS and motor impairment impairing normal writing will be recruited
      with a duration of participation of four weeks per patient. The intervention will consist in
      a training program to the device during six visits on site allowing a gradual acquisition of
      the ability to perform an eye-writing. The primary endpoint is the recognition by an outside
      observer of the digits 0-9 produced by the patient with the device. The secondary criteria is
      the record of adverse events and serious adverse events occurred during the study other than
      those directly related to ALS.

      Discussion/Conclusions: EOL device potentially offers a creative and personal means of
      linguistic and emotional expression in subject with motor disability. The study is open to
      patients recruitment since June 2014. Results are expected in mid 2015.
    

Intervention name(s): EOL (Eye On Line)
Intervention type(s): Device
Intervention description(s): the intervention consists in training program allowing a gradual acquisition of the eye-writing
Intervention model: Single Group Assignment
Masking: None (Open Label)