Safety and Feasibility of the EyeControl Device

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-30

Study Completion Date

2017-02-28

Brief Summary

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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.

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Detailed Description

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Conditions

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ALS (Amyotrophic Lateral Sclerosis)

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Device use in Healthy volunteers

10 healthy volunteers will be recruited

Group Type EXPERIMENTAL

EyeControl device

Intervention Type DEVICE

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

Device use in ALS patients

5 ALS patients in early stages will be recruited

Group Type EXPERIMENTAL

EyeControl device

Intervention Type DEVICE

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

Interventions

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EyeControl device

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Subjects 18 to 65 years old
2. Subject with understandable speaking communication
3. Subject fluent in Hebrew (speech and writing skills)

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes