Safety and Feasibility of the EyeControl Device
1 other identifier
interventional
15
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2016
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 29, 2016
CompletedStudy Start
First participant enrolled
September 1, 2016
CompletedFirst Posted
Study publicly available on registry
September 7, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 28, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2017
CompletedResults Posted
Study results publicly available
August 28, 2019
CompletedAugust 28, 2019
August 1, 2019
5 months
August 29, 2016
July 17, 2019
August 8, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Safety Assessment - Number of Device Related Adverse Events
2 weeks
Study Arms (2)
Device use in Healthy volunteers
EXPERIMENTAL10 healthy volunteers will be recruited
Device use in ALS patients
EXPERIMENTAL5 ALS patients in early stages will be recruited
Interventions
Use of device features including control of gestures, use of menus, activation of pre- defined modes and writing full sentences
Eligibility Criteria
You may qualify if:
- Subjects 18 to 65 years old
- Subject with understandable speaking communication
- Subject fluent in Hebrew (speech and writing skills)
- Subjects with early stage ALS diagnosis - whose speech capability is unaffected
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Or Retzkin, CEO
- Organization
- EyeFree Assisting Communication
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 29, 2016
First Posted
September 7, 2016
Study Start
September 1, 2016
Primary Completion
January 28, 2017
Study Completion
February 28, 2017
Last Updated
August 28, 2019
Results First Posted
August 28, 2019
Record last verified: 2019-08