Safety and Feasibility of the EyeControl Device

Eyefree Assisting Communication Ltd

Status: Completed

Conditions: ALS (Amyotrophic Lateral Sclerosis)

Treatments: Device: EyeControl device

Study type: Interventional

Funder types: Industry

Identifiers

NCT02891629

EFAC-01

Details and patient eligibility

About

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.

Enrollment: 15 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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15 participants in 2 patient groups

Device use in Healthy volunteers

Experimental group

Description:

10 healthy volunteers will be recruited

Treatment:

Device: EyeControl device

Device use in ALS patients

Experimental group

Description:

5 ALS patients in early stages will be recruited

Treatment:

Device: EyeControl device