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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

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.

Condition or disease Intervention/treatment Phase
ALS (Amyotrophic Lateral Sclerosis) Device: EyeControl device Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Safety and Feasibility of the EyeControl Device (Eye-based Communication Device) for ALS Patients
Actual Study Start Date : September 2016
Actual Primary Completion Date : January 28, 2017
Actual Study Completion Date : February 28, 2017


Arm Intervention/treatment
Experimental: Device use in Healthy volunteers
10 healthy volunteers will be recruited
Device: EyeControl device
Use of device features including control of gestures, use of menus, activation of pre- defined modes and writing full sentences

Experimental: Device use in ALS patients
5 ALS patients in early stages will be recruited
Device: EyeControl device
Use of device features including control of gestures, use of menus, activation of pre- defined modes and writing full sentences




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
  Study Documents (Full-Text)

Documents provided by Eyefree Assisting Communication Ltd:
Study Protocol  [PDF] May 16, 2016
No Statistical Analysis Plan (SAP) exists for this study.

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Responsible Party: Eyefree Assisting Communication Ltd
ClinicalTrials.gov Identifier: NCT02891629    
Other Study ID Numbers: EFAC-01
First Posted: September 7, 2016    Key Record Dates
Results First Posted: August 28, 2019
Last Update Posted: August 28, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Neurodegenerative Diseases
Nervous System Diseases
Neuromuscular Diseases
Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases