Safety and Feasibility of the EyeControl Device
Primary Purpose
ALS (Amyotrophic Lateral Sclerosis)
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
EyeControl device
Sponsored by
About this trial
This is an interventional supportive care trial for ALS (Amyotrophic Lateral Sclerosis)
Eligibility Criteria
Inclusion Criteria:
- Subjects 18 to 65 years old
- Subject with understandable speaking communication
Subject fluent in Hebrew (speech and writing skills)
Additional inclusion criteria for Stage 2 of the study:
- Subjects with early stage ALS diagnosis - whose speech capability is unaffected
Exclusion Criteria:
- Subjects with glasses or contact lenses
- Subjects with eye conditions such as Ptosis, Strabismus And Crossed Eyes
- Medical history of epilepsy
- Subjects who according to investigator's judgement, unable to comply with the requirements of this protocol
- Pregnant or lactating women
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Device use in Healthy volunteers
Device use in ALS patients
Arm Description
10 healthy volunteers will be recruited
5 ALS patients in early stages will be recruited
Outcomes
Primary Outcome Measures
Feasibility - Successful Performance Rate of Device Features
Ability to successfully perform at least 70% of device features (controlling the application and Free text features)
Secondary Outcome Measures
Safety Assessment - Number of Device Related Adverse Events
number of device related adverse events reported during the use of the device
Full Information
NCT ID
NCT02891629
First Posted
August 29, 2016
Last Updated
August 8, 2019
Sponsor
Eyefree Assisting Communication Ltd
1. Study Identification
Unique Protocol Identification Number
NCT02891629
Brief Title
Safety and Feasibility of the EyeControl Device
Official Title
Safety and Feasibility of the EyeControl Device (Eye-based Communication Device) for ALS Patients
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
September 2016 (Actual)
Primary Completion Date
January 28, 2017 (Actual)
Study Completion Date
February 28, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eyefree Assisting Communication Ltd
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ALS (Amyotrophic Lateral Sclerosis)
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Device use in Healthy volunteers
Arm Type
Experimental
Arm Description
10 healthy volunteers will be recruited
Arm Title
Device use in ALS patients
Arm Type
Experimental
Arm Description
5 ALS patients in early stages will be recruited
Intervention Type
Device
Intervention Name(s)
EyeControl device
Intervention Description
Use of device features including control of gestures, use of menus, activation of pre- defined modes and writing full sentences
Primary Outcome Measure Information:
Title
Feasibility - Successful Performance Rate of Device Features
Description
Ability to successfully perform at least 70% of device features (controlling the application and Free text features)
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Safety Assessment - Number of Device Related Adverse Events
Description
number of device related adverse events reported during the use of the device
Time Frame
2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Subjects 18 to 65 years old
Subject with understandable speaking communication
Subject fluent in Hebrew (speech and writing skills)
Additional inclusion criteria for Stage 2 of the study:
Subjects with early stage ALS diagnosis - whose speech capability is unaffected
Exclusion Criteria:
Subjects with glasses or contact lenses
Subjects with eye conditions such as Ptosis, Strabismus And Crossed Eyes
Medical history of epilepsy
Subjects who according to investigator's judgement, unable to comply with the requirements of this protocol
Pregnant or lactating women
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Safety and Feasibility of the EyeControl Device
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