Safety and Feasibility of the EyeControl Device

ALS (Amyotrophic Lateral Sclerosis) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02891629
• Other study ID #: EFAC-01
• Status: Completed
• Phase: N/A
• Start date: September 2016
• Est. completion date: February 28, 2017

Study information

• Verified date: August 2019
• Source: Eyefree Assisting Communication Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: February 28, 2017
• Est. primary completion date: January 28, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• ALS (Amyotrophic Lateral Sclerosis)
• Amyotrophic Lateral Sclerosis
• Motor Neuron Disease

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Eyefree Assisting Communication Ltd

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Safety Assessment - Number of Device Related Adverse Events	number of device related adverse events reported during the use of the device	2 weeks