Safety and Feasibility of the EyeControl Device

Not Applicable

Completed

• Conditions: ALS (Amyotrophic Lateral Sclerosis)

• Registration Number: NCT02891629
• Lead Sponsor: Eyefree Assisting Communication Ltd

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-08-29
• Study Start: 2016-09
• Study First Submitted QC: 2016-09-01
• Study First Posted: 2016-09-07
• Primary Completion: 2017-01-28
• Study Completion: 2017-02-28
• Results First Submitted: 2019-07-17
• Status Verified: 2019-08
• Results First Submitted QC: 2019-08-08
• Last Update Submitted: 2019-08-08
• Results First Posted: 2019-08-28
• Last Update Posted: 2019-08-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Feasibility - Successful Performance Rate of Device Features	2 weeks	Ability to successfully perform at least 70% of device features (controlling the application and Free text features)

Secondary Outcome Measures

Name	Time	Method
Safety Assessment - Number of Device Related Adverse Events	2 weeks	number of device related adverse events reported during the use of the device