Safety and Feasibility of the EyeControl Device

Safety and Feasibility of the EyeControl Device (Eye-based Communication Device) for ALS Patients

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 Overview

• Status: Completed
• Conditions: ALS (Amyotrophic Lateral Sclerosis)
• Intervention / Treatment: Device: EyeControl device

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Device use in Healthy volunteers; 10 healthy volunteers will be recruited	Device: EyeControl device; Use of device features including control of gestures, use of menus, activation of pre- defined modes and writing full sentences
Experimental: Device use in ALS patients; 5 ALS patients in early stages will be recruited	Device: EyeControl device; Use of device features including control of gestures, use of menus, activation of pre- defined modes and writing full sentences

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety Assessment - Number of Device Related Adverse Events	number of device related adverse events reported during the use of the device	2 weeks

Collaborators and Investigators

• Sponsor: Eyefree Assisting Communication Ltd

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2016
• Primary Completion (Actual): January 28, 2017
• Study Completion (Actual): February 28, 2017

Study Registration Dates

• First Submitted: August 29, 2016
• First Submitted That Met QC Criteria: September 1, 2016
• First Posted (Estimate): September 7, 2016

Study Record Updates

• Last Update Posted (Actual): August 28, 2019
• Last Update Submitted That Met QC Criteria: August 8, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Central Nervous System Diseases; Nervous System Diseases; Neuromuscular Diseases; Neurodegenerative Diseases; Spinal Cord Diseases; TDP-43 Proteinopathies; Proteostasis Deficiencies; Motor Neuron Disease; Amyotrophic Lateral Sclerosis
• Other Study ID Numbers: EFAC-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided