A New Eye-based Communication Device for ALS Patients (ELY-SLA)

A Pilot Study Assessing a New Eye-writing Device Allowing Cursive Writing With Smooth Pursuit Eye Movements in Subjects With ALS

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.

Study Overview

• Status: Completed
• Conditions: Amyotrophic Lateral Sclerosis
• Intervention / Treatment: Device: EOL (Eye On Line)

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.

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Paris, France, 75013
    • Groupe Hospitalier Pitié Salpêtrière

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion criteria :

• 18 to 65 years old
• patient with SLA diagnosis
• patient presenting writing troubles
• patient with understandable speaking communication
• patient with health insurance

Exclusion criteria :

• patients presenting oculomotricity troubles
• patients presenting frontotemporal dementia
• patients presenting a chronic incapacitating disease other than ALS
• patients presenting epilepsy antecedents
• patents included in an other clinical study

Study Plan

How is the study designed?

Design Details

• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: EOL (Eye On Line); training program allowing a gradual acquisition of the eye-writing	Device: EOL (Eye On Line); the intervention consists in training program allowing a gradual acquisition of the eye-writing

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
recognition by an outside observer of the digits 0-9 produced by the patient with the device	4 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
adverse events	4 weeks

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborators: National Research Agency, France
• Investigators: Principal Investigator: Lucette Lacomblez, MD, PhD, Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start: June 1, 2014
• Primary Completion (Actual): April 1, 2015
• Study Completion (Actual): April 1, 2015

Study Registration Dates

• First Submitted: December 5, 2014
• First Submitted That Met QC Criteria: December 5, 2014
• First Posted (Estimate): December 10, 2014

Study Record Updates

• Last Update Posted (Estimate): November 26, 2015
• Last Update Submitted That Met QC Criteria: November 25, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Central Nervous System Diseases; Nervous System Diseases; Neuromuscular Diseases; Neurodegenerative Diseases; Spinal Cord Diseases; TDP-43 Proteinopathies; Proteostasis Deficiencies; Motor Neuron Disease; Amyotrophic Lateral Sclerosis
• Other Study ID Numbers: P131101