Safety and Feasibility of the EyeControl Device

Eyefree Assisting Communication Ltd15 enrolled

Overview

The EyeControl device is an eye movement-based communication device in the form of wearable glasses with connected infrared cam-era that tracks the pupil and translates blinks and movements into commands.This study is aimed to demonstrate the safety and feasibility of the EyeControl device in healthy volunteers, and ALS patients in early stages.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

ALS (Amyotrophic Lateral Sclerosis)

Interventions

EyeControl deviceDEVICE

Use of device features including control of gestures, use of menus, activation of pre- defined modes and writing full sentences

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. Subjects 18 to 65 years old 2. Subject with understandable speaking communication 3. Subject fluent in Hebrew (speech and writing skills) Additional inclusion criteria for Stage 2 of the study: 4. Subjects with early stage ALS diagnosis - whose speech capability is unaffected Exclusion Criteria: 1. Subjects with glasses or contact lenses 2. Subjects with eye conditions such as Ptosis, Strabismus And Crossed Eyes 3. Medical history of epilepsy 4. Subjects who according to investigator's judgement, unable to comply with the requirements of this protocol 5. Pregnant or lactating women

Outcomes

Primary Outcomes

Feasibility - Successful Performance Rate of Device Features

Ability to successfully perform at least 70% of device features (controlling the application and Free text features)

Time frame: 2 weeks

Secondary Outcomes

Safety Assessment - Number of Device Related Adverse Events

number of device related adverse events reported during the use of the device

Time frame: 2 weeks

Data from ClinicalTrials.gov

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