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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
Eyefree Assisting Communication Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for ALS (Amyotrophic Lateral Sclerosis)

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

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

    First Posted
    August 29, 2016
    Last Updated
    August 8, 2019
    Sponsor
    Eyefree Assisting Communication Ltd
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    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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