A New Eye-based Communication Device for ALS Patients (ELY-SLA)
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|ClinicalTrials.gov Identifier: NCT02313402|
Recruitment Status : Completed
First Posted : December 10, 2014
Last Update Posted : November 26, 2015
|Condition or disease||Intervention/treatment||Phase|
|Amyotrophic Lateral Sclerosis||Device: EOL (Eye On Line)||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Study Assessing a New Eye-writing Device Allowing Cursive Writing With Smooth Pursuit Eye Movements in Subjects With ALS|
|Study Start Date :||June 2014|
|Actual Primary Completion Date :||April 2015|
|Actual Study Completion Date :||April 2015|
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
- recognition by an outside observer of the digits 0-9 produced by the patient with the device [ Time Frame: 4 weeks ]
- adverse events [ Time Frame: 4 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02313402
|Groupe Hospitalier Pitie Salpetriere|
|Paris, France, 75013|
|Principal Investigator:||Lucette Lacomblez, MD, PhD||Assistance Publique - Hôpitaux de Paris|