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OpenTrials
Completed

NCT Number: NCT02891629

Safety and Feasibility of the EyeControl Device

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.

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Key information

Conditions

ALS (Amyotrophic Lateral Sclerosis) Amyotrophic Lateral Sclerosis Central Nervous System Diseases Metabolic Diseases Motor Neuron Disease Nervous System Diseases Neurodegenerative Diseases Neuromuscular Diseases Nutritional and Metabolic Diseases Proteostasis Deficiencies Spinal Cord Diseases TDP-43 Proteinopathies

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

EyeControl device

Device

Use of device features including control of gestures, use of menus, activation of pre- defined modes and writing full sentences

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Eyefree Assisting Communication Ltd

Industry

Registry information

Official study title

Safety and Feasibility of the EyeControl Device (Eye-based Communication Device) for ALS Patients

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Sep 7, 2016
Registry last updated
Aug 28, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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