N/A
Completed N=15
Safety and Feasibility of the EyeControl Device
ALS (Amyotrophic Lateral Sclerosis)
Source: ClinicalTrials.gov NCT02891629 ↗
Enrolled (actual)
15
Serious AEs
0.0%
Results posted
Aug 2019
Primary outcomePrimary: Feasibility - Successful Performance Rate of Device Features — 4.9; 7.2 seconds
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Feasibility - Successful Performance Rate of Device Features |
4.9; 7.2 | — |
| SECONDARY Safety Assessment - Number of Device Related Adverse Events |
2; 0 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02891629). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.