ALS (Amyotrophic Lateral Sclerosis)
Conditions
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.
Interventions
DEVICEEyeControl device
Use of device features including control of gestures, use of menus, activation of pre- defined modes and writing full sentences
Sponsors
Eyefree Assisting Communication Ltd
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility - Successful Performance Rate of Device Features | 2 weeks | Ability to successfully perform at least 70% of device features (controlling the application and Free text features) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety Assessment - Number of Device Related Adverse Events | 2 weeks | number of device related adverse events reported during the use of the device |
Participant flow
Pre-assignment details
Investigator decided to terminate subject participation due to the discovery of cataract during the trial.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 10 |
| 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 | 4 |
| Total | 14 |
Baseline characteristics
| Characteristic | Device Use in ALS Patients | Total | Device Use in Healthy Volunteers |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 4 Participants | 14 Participants | 10 Participants |
| Age, Continuous | 46.25 years STANDARD_DEVIATION 5.26 | 36.6 years STANDARD_DEVIATION 11.35 | 30.3 years STANDARD_DEVIATION 9.83 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment Israel | 4 participants | 14 participants | 10 participants |
| Sex: Female, Male Female | 0 Participants | 5 Participants | 5 Participants |
| Sex: Female, Male Male | 4 Participants | 9 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 5 |
| other Total, other adverse events | 1 / 10 | 0 / 5 |
| serious Total, serious adverse events | 0 / 10 | 0 / 5 |
Outcome results
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)
Time frame: 2 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Device Use in Healthy Volunteers | Feasibility - Successful Performance Rate of Device Features | 4.9 seconds | Standard Deviation 1.3 |
| Device Use in ALS Patients | Feasibility - Successful Performance Rate of Device Features | 7.2 seconds | Standard Deviation 2.2 |
Secondary
Safety Assessment - Number of Device Related Adverse Events
number of device related adverse events reported during the use of the device
Time frame: 2 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Device Use in Healthy Volunteers | Safety Assessment - Number of Device Related Adverse Events | 2 events |
| Device Use in ALS Patients | Safety Assessment - Number of Device Related Adverse Events | 0 events |