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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Device use in Healthy volunteers | Experimental | 10 healthy volunteers will be recruited |
|
| Device use in ALS patients | Experimental | 5 ALS patients in early stages will be recruited |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EyeControl device | Device | Use of device features including control of gestures, use of menus, activation of pre- defined modes and writing full sentences |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Safety Assessment - Number of Device Related Adverse Events | number of device related adverse events reported during the use of the device | 2 weeks |
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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:
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Investigator decided to terminate subject participation due to the discovery of cataract during the trial.
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| ID | Title | Description |
|---|---|---|
| FG000 | Device Use in Healthy Volunteers | 10 healthy volunteers will be recruited EyeControl device: Use of device features including control of gestures, use of menus, activation of pre- defined modes and writing full sentences |
| FG001 | Device Use in ALS Patients | 5 ALS patients in early stages will be recruited EyeControl device: Use of device features including control of gestures, use of menus, activation of pre- defined modes and writing full sentences |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Device Use in Healthy Volunteers | 10 healthy volunteers will be recruited EyeControl device: Use of device features including control of gestures, use of menus, activation of pre- defined modes and writing full sentences |
| BG001 | Device Use in ALS Patients |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Feasibility - Successful Performance Rate of Device Features | Ability to successfully perform at least 70% of device features (controlling the application and Free text features) | Posted | Mean | Standard Deviation | seconds | 2 weeks |
|
The adverse events data was collected only during the trial, meaning during the 4 sessions, of about 2.5-3 hours, for each participant, performed over 2 weeks' time.
An AE can be any unintended sign, symptom, disease or injury or any untoward clinical signs (including an abnormal laboratory findings) in subjects, users or other persons whether or not related to the investigational medical device.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Device Use in Healthy Volunteers | 10 healthy volunteers will be recruited EyeControl device: Use of device features including control of gestures, use of menus, activation of pre- defined modes and writing full sentences |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dry Eyes | Eye disorders | Non-systematic Assessment | Participant complained on dry eyes |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Or Retzkin, CEO | EyeFree Assisting Communication | +972526490093 | or@eyecontrol.co.il |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 16, 2016 | Aug 8, 2019 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D000690 | Amyotrophic Lateral Sclerosis |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D016472 | Motor Neuron Disease |
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5 ALS patients in early stages will be recruited EyeControl device: Use of device features including control of gestures, use of menus, activation of pre- defined modes and writing full sentences |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Safety Assessment - Number of Device Related Adverse Events | number of device related adverse events reported during the use of the device | Posted | Number | events | 2 weeks |
|
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| 1 |
| 10 |
| EG001 | Device Use in ALS Patients | 5 ALS patients in early stages will be recruited EyeControl device: Use of device features including control of gestures, use of menus, activation of pre- defined modes and writing full sentences | 0 | 5 | 0 | 5 | 0 | 5 |
| Eye Fatigue | Eye disorders | Non-systematic Assessment | Participant complained on eye fatigue |
|
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| D019636 | Neurodegenerative Diseases |
| D057177 | TDP-43 Proteinopathies |
| D009468 | Neuromuscular Diseases |
| D057165 | Proteostasis Deficiencies |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |