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Safety and Feasibility of the EyeControl Device

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02891629
Recruitment Status : Completed
First Posted : September 7, 2016
Results First Posted : August 28, 2019
Last Update Posted : August 28, 2019
Sponsor:
Information provided by (Responsible Party):
Eyefree Assisting Communication Ltd

Tracking Information
First Submitted Date  ICMJE August 29, 2016
First Posted Date  ICMJE September 7, 2016
Results First Submitted Date  ICMJE July 17, 2019
Results First Posted Date  ICMJE August 28, 2019
Last Update Posted Date August 28, 2019
Actual Study Start Date  ICMJE September 2016
Actual Primary Completion Date January 28, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 1, 2016)
Feasibility - Successful Performance Rate of Device Features [ Time Frame: 2 weeks ]
Ability to successfully perform at least 70% of device features (controlling the application and Free text features)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 1, 2016)
Safety Assessment - Number of Device Related Adverse Events [ Time Frame: 2 weeks ]
number of device related adverse events reported during the use of the device
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Feasibility of the EyeControl Device
Official Title  ICMJE Safety and Feasibility of the EyeControl Device (Eye-based Communication Device) for ALS Patients
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE ALS (Amyotrophic Lateral Sclerosis)
Intervention  ICMJE Device: EyeControl device
Use of device features including control of gestures, use of menus, activation of pre- defined modes and writing full sentences
Study Arms  ICMJE
  • Experimental: Device use in Healthy volunteers
    10 healthy volunteers will be recruited
    Intervention: Device: EyeControl device
  • Experimental: Device use in ALS patients
    5 ALS patients in early stages will be recruited
    Intervention: Device: EyeControl device
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 1, 2016)
15
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 28, 2017
Actual Primary Completion Date January 28, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02891629
Other Study ID Numbers  ICMJE EFAC-01
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Eyefree Assisting Communication Ltd
Study Sponsor  ICMJE Eyefree Assisting Communication Ltd
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Eyefree Assisting Communication Ltd
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP