ALS (Amyotrophic Lateral Sclerosis)NCT02891629

Safety and Feasibility of the EyeControl Device

A study of ALS (Amyotrophic Lateral Sclerosis), run by Eyefree Assisting Communication Ltd.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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… Read more about this study

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: ALS (Amyotrophic Lateral Sclerosis)
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 15 participants
Where: No sites listed yet
Study dates: Sep 2016to 28 Feb 2017
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

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

About this study

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

Conditions: ALS (Amyotrophic Lateral Sclerosis)
Being tested: EyeControl device
Medical subject headings: Amyotrophic Lateral Sclerosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT02891629
Study group	Role	What they receive
Device use in Healthy volunteers	Experimental	10 healthy volunteers will be recruited Receives: Device: EyeControl device
Device use in ALS patients	Experimental	5 ALS patients in early stages will be recruited Receives: Device: EyeControl device

What is being measured

The primary outcome is the main question the study is designed to answer.

Feasibility - Successful Performance Rate of Device Features
Ability to successfully perform at least 70% of device features (controlling the application and Free text features)
Measured: 2 weeks

Secondary outcomes (1)

Safety Assessment - Number of Device Related Adverse Events
number of device related adverse events reported during the use of the device
Measured: 2 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 201628 Feb 2017

First posted7 Sep 2016 (estimated)
Study startSep 2016
Primary completion28 Jan 2017
Study completion28 Feb 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for ALS (Amyotrophic Lateral Sclerosis)Studies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 15 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02891629
Sponsor's protocol ID: EFAC-01
Status last verified: Aug 2019
First submitted: 29 Aug 2016
Last updated: 28 Aug 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

RecruitingPhase 1/2
Study is to Assess the Safety and Tolerability of VTx-002 in Participants With ALS
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Safety, Tolerability, and Pharmacodynamic Exploration of Orelabrutinib in Patients With Amyotrophic Lateral Sclerosis (ALS)
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All ALS (Amyotrophic Lateral Sclerosis) trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Safety and Feasibility of the EyeControl Device (Eye-based Communication Device) for ALS Patients
ClinicalTrials.gov ID: NCT02891629
Acronym / sponsor ID: EFAC-01
Conditions: ALS (Amyotrophic Lateral Sclerosis)
Study type: Interventional
Recruitment status: Completed
Enrolment: 15 participants (actual)
Lead sponsor: Eyefree Assisting Communication LtdIndustry (pharma, biotech, devices)
Study start: Sep 2016 (actual)
Primary completion: 28 Jan 2017 (actual)
Study completion: 28 Feb 2017 (actual)
First posted: 7 Sep 2016 (estimated)
Results: Posted 28 Aug 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Supportive care
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Device use in Healthy volunteers	Experimental	Device: EyeControl device10 healthy volunteers will be recruited
Device use in ALS patients	Experimental	Device: EyeControl device5 ALS patients in early stages will be recruited

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Subjects 18 to 65 years old
Subject with understandable speaking communication
Subject fluent in Hebrew (speech and writing skills)
Subjects with early stage ALS diagnosis - whose speech capability is unaffected

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
EyeControl deviceUse of device features including control of gestures, use of menus, activation of pre- defined modes and writing full sentences	Device	Device use in ALS patients, Device use in Healthy volunteers

Primary outcome

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)

1 secondary outcome

Safety Assessment - Number of Device Related Adverse Events
Time frame: 2 weeks

Results and safety

Results posted to the registry on 28 Aug 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Device Use in Healthy Volunteers	10	10
Device Use in ALS Patients	5	4

Primary outcome: Feasibility - Successful Performance Rate of Device Features

Time frame: 2 weeks. Mean (Standard Deviation). Unit: seconds

Measure	Device Use in Healthy Volunteers n = 10	Device Use in ALS Patients n = 4
Value	4.9 (1.3)	7.2 (2.2)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 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.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Device Use in Healthy Volunteers	0 of 10 (0%)	1 of 10 (10%)	0 of 10
Device Use in ALS Patients	0 of 5 (0%)	0 of 5 (0%)	0 of 5

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Undecided

Related trials for ALS (Amyotrophic Lateral Sclerosis)

RecruitingPhase 1/2
Study is to Assess the Safety and Tolerability of VTx-002 in Participants With ALS
Amyotrophic Lateral Sclerosis
Not yet recruiting
A Study on the Addition of Alsum30 for the Treatment of Amyotrophic Lateral Sclerosis
Amyotrophic Lateral Sclerosis (ALS), Bacillus Coagulans
Active, not recruiting
Functional Outcomes and Control Using Synchron BCI - Australia
Neurologic Disorder, Neurologic Diseases
Not yet recruitingPhase 1
Safety, Tolerability, and Pharmacodynamic Exploration of Orelabrutinib in Patients With Amyotrophic Lateral Sclerosis (ALS)
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Recruiting
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

A study of ALS (Amyotrophic Lateral Sclerosis), run by Eyefree Assisting Communication Ltd.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Aug 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility - Successful Performance Rate of Device Features (time frame: 2 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02891629.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2019.