ALS (Amyotrophic Lateral Sclerosis)NCT06810219
Augmented Reality BCI Longitudinal Study for Persons With Late Stage ALS
A study testing Cognixion ONE in people with ALS (Amyotrophic Lateral Sclerosis), run by Cognixion at 1 site in United States.
Trial summary
The goal of this study is refine the usability of a BCI based communication platform. The study will take place in the greater Los Angeles area and will enroll up to 10 participants with late stage ALS. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ALS (Amyotrophic Lateral Sclerosis)
- What is being tested?
- Cognixion ONE
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jan 2025to 31 Oct 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must have someone (LAR) who can consent to their participation and who will be present in the study alongside the participant
- Must have a designated individual who can be trained on the Cognixion system
- Fluent in understanding English
- 18 years or older
- Must have ALS and need an assistive communication device
- Must be able to engage in volitional eye opening and sustain eye opening independently for x duration
- Must have a way to communicate apart from using the Cognixion device such as vocalizations, head nod, eye blinks, eyebrow raises, etc. At a minimum, reliable way of communicating "Yes" and "No"
Who cannot join
- Disruption in English comprehension, either due to lack of fluent proficiency or due to a developmental/acquired language disorder (e.g. aphasia)
- Severely hearing impaired or deaf
- Sensitivity to flashing lights
- History of epilepsy and/or seizures
- Vision disorders restricting the visual field such as glaucoma, diplopia (double vision), nystagmus (involuntary eye movements)
- History of vertigo or other vestibular disorders
- Scalp that is prone to irritation, inflammation, injury, or infectious process
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Cognixion
Santa Barbara, California, 93101-1665
Chris Ullrich, 8053200774, chris@cognixion.com
Cole Study Coordinator, 214-907-6399, cole@cognixion.com
About this study
Official title: Cognixion ALS BCI Longitudinal Study
The goal of this study is refine the usability of a BCI based communication platform.
The study will take place in the greater Los Angeles area and will enroll up to 10 participants with late stage ALS. Each subject will receive a Cognixion Axon-R augmented reality brain computer interface and associated communication software. The study duration is 3 months for each participant.
Read more
The key questions that will be addressed in this study are:
- How quickly can participants learn and gain confidence with a pure BCI interface.
- How effective are alternate input modalities including eye tracking for this use case.
- Identify the extent to which generative AI based personalization impacts the communication quality.
Key measures include:
ITR - information transfer rate SUS - system usability scale
- Conditions
- ALS (Amyotrophic Lateral Sclerosis)
- Being tested
- Cognixion ONE
- Keywords
- usability study, augmented reality, brain computer interface, Amyotrophic lateral sclerosis, als, generative AI, longitudinal study
- 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.
Cognixion ONEDevice
A wearable augmented reality brain computer interface with self contained computer and software to enable communication using the device input and output capabilities.
| Study group | Role | What they receive |
|---|---|---|
| Usability Study | Experimental | Participants will utilize the Cognixion Axon-R device and associated communication software for practice and communication tasks as prescribed by the study administrator. Receives: Device: Cognixion ONE |
What is being measured
The primary outcome is the main question the study is designed to answer.
System Usability Score
A score ranging from 0 to 100 that captures the usability the device. This is an essential characteristic of a device feasibility study.
Measured: 3 months from training and setup of device.
Information Transfer Rate (ITR)
The rate, in bits per minute, of information transfer for each of the device modalities.
ITR is measured using a standardized selection procedure.
Measured: 3 months from training and setup of device.
Secondary outcomes (1)
Words per Minute (WPM)
WPM is the number of words that a participant can speak in one minute. This statistic is calculated by counting the total time from partner utterance until a response is spoken by the participant.
Measured: 3 months from training and setup of device.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2025
- Study start20 Jan 2025
- Primary completion30 Aug 2025 (estimated)
- Study completion31 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cognixion
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Chris Principal Investigator, Principal investigator, Cognixion
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06810219
- Sponsor's protocol ID
- ALSUS1
- Status last verified
- Jan 2025
- First submitted
- 22 Jan 2025
- Last updated
- 5 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Usability insights related to this use case on this type of device will be shared with other accessibility and BCI researchers at conference events and through publications.
Publications
Lewis, J. R. (2018). The System Usability Scale: Past, Present, and Future. International Journal of Human-Computer Interaction, 34(7), 577-590
Kellmeyer P, Grosse-Wentrup M, Schulze-Bonhage A, Ziemann U, Ball T. Electrophysiological correlates of neurodegeneration in motor and non-motor brain regions in amyotrophic lateral sclerosis-implications for brain-computer interfacing. J Neural Eng. 2018 Aug;15(4):041003. doi: 10.1088/1741-2552/aabfa5. Epub 2018 Apr 20.
PubMed 29676287Wolpaw JR, Bedlack RS, Reda DJ, Ringer RJ, Banks PG, Vaughan TM, Heckman SM, McCane LM, Carmack CS, Winden S, McFarland DJ, Sellers EW, Shi H, Paine T, Higgins DS, Lo AC, Patwa HS, Hill KJ, Huang GD, Ruff RL. Independent home use of a brain-computer interface by people with amyotrophic lateral sclerosis. Neurology. 2018 Jul 17;91(3):e258-e267. doi: 10.1212/WNL.0000000000005812. Epub 2018 Jun 27.
PubMed 29950436
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognixion ALS BCI Longitudinal Study
- ClinicalTrials.gov ID
- NCT06810219
- Acronym / sponsor ID
- ALSUS1
- Conditions
- ALS (Amyotrophic Lateral Sclerosis)
- Keywords
- usability study, augmented reality, brain computer interface, Amyotrophic lateral sclerosis, als, generative AI, longitudinal study
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- CognixionIndustry (pharma, biotech, devices)
- Study start
- 20 Jan 2025 (actual)
- Primary completion
- 30 Aug 2025 (estimated)
- Study completion
- 31 Oct 2025 (estimated)
- First posted
- 5 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this study is refine the usability of a BCI based communication platform.
The study will take place in the greater Los Angeles area and will enroll up to 10 participants with late stage ALS. Each subject will receive a Cognixion Axon-R augmented reality brain computer interface and associated communication software. The study duration is 3 months for each participant.
The key questions that will be addressed in this study are:
- How quickly can participants learn and gain confidence with a pure BCI interface.
- How effective are alternate input modalities including eye tracking for this use case.
- Identify the extent to which generative AI based personalization impacts the communication quality.
Key measures include:
ITR - information transfer rate SUS - system usability scale
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Usability Study | Experimental | Device: Cognixion ONEParticipants will utilize the Cognixion Axon-R device and associated communication software for practice and communication tasks as prescribed by the study administrator. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Must have someone (LAR) who can consent to their participation and who will be present in the study alongside the participant
- Must have a designated individual who can be trained on the Cognixion system
- Fluent in understanding English
- 18 years or older
- Must have ALS and need an assistive communication device
Key exclusion criteria (7 listed)
- Disruption in English comprehension, either due to lack of fluent proficiency or due to a developmental/acquired language disorder (e.g. aphasia)
- Severely hearing impaired or deaf
- Sensitivity to flashing lights
- History of epilepsy and/or seizures
- Vision disorders restricting the visual field such as glaucoma, diplopia (double vision), nystagmus (involuntary eye movements)
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 |
|---|---|---|
| Cognixion ONEA wearable augmented reality brain computer interface with self contained computer and software to enable communication using the device input and output capabilities. | Device | Usability Study |
Primary outcome
System Usability Score
Time frame: 3 months from training and setup of device.
A score ranging from 0 to 100 that captures the usability the device. This is an essential characteristic of a device feasibility study.
Information Transfer Rate (ITR)
Time frame: 3 months from training and setup of device.
The rate, in bits per minute, of information transfer for each of the device modalities. ITR is measured using a standardized selection procedure.
1 secondary outcome
Words per Minute (WPM)
Time frame: 3 months from training and setup of device.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2025.
- BackgroundLewis, J. R. (2018). The System Usability Scale: Past, Present, and Future. International Journal of Human-Computer Interaction, 34(7), 577-590
- Background: PubMed 29676287Kellmeyer P, Grosse-Wentrup M, Schulze-Bonhage A, Ziemann U, Ball T. Electrophysiological correlates of neurodegeneration in motor and non-motor brain regions in amyotrophic lateral sclerosis-implications for brain-computer interfacing. J Neural Eng. 2018 Aug;15(4):041003. doi: 10.1088/1741-2552/aabfa5. Epub 2018 Apr 20.
- Background: PubMed 29950436Wolpaw JR, Bedlack RS, Reda DJ, Ringer RJ, Banks PG, Vaughan TM, Heckman SM, McCane LM, Carmack CS, Winden S, McFarland DJ, Sellers EW, Shi H, Paine T, Higgins DS, Lo AC, Patwa HS, Hill KJ, Huang GD, Ruff RL. Independent home use of a brain-computer interface by people with amyotrophic lateral sclerosis. Neurology. 2018 Jul 17;91(3):e258-e267. doi: 10.1212/WNL.0000000000005812. Epub 2018 Jun 27.
- Individual participant dataSharing planned: Yes. Usability insights related to this use case on this type of device will be shared with other accessibility and BCI researchers at conference events and through publications.
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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.
Chris Principal Investigator principal investigator
Cognixion
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognixion ONE in people with ALS (Amyotrophic Lateral Sclerosis), run by Cognixion at 1 site in United States.
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 7 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 5 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christopher Principal Investigator (8053200774, chris@cognixion.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
System Usability Score (time frame: 3 months from training and setup of device.). The study lists 2 primary outcomes in all. 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 NCT06810219, which also lists 3 linked publications.
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 5 Feb 2025.