ALS (Amyotrophic Lateral Sclerosis)NCT07209943
Augmented Reality BCI Longitudinal Study for Persons With ALS, Stroke, TBI and SCI Utilizing Cognixion + Apple Vision Pro
A study testing Cognixion + Apple Vision Pro in people with ALS (Amyotrophic Lateral Sclerosis) and TBI Traumatic Brain Injury, run by Cognixion at 1 site in United States.
Trial summary
The goal of this study is refine the usability of a BCI capable communication platform. The study will take place in the United States area and will enroll up to 10 participants with late stage ALS, traumatic brain injury (TBI) or spinal cord injury (SCI) that have assistive communication and computer control needs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ALS (Amyotrophic Lateral Sclerosis), TBI Traumatic Brain Injury, SCI - Spinal Cord Injury
- What is being tested?
- Cognixion + Apple Vision Pro
- 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
- 16 Oct 2025to 31 May 2026
- 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 a designated on-site support individual who can be trained on the Cognixion system
- Fluent in understanding English
- 18 years or older
- Must have one of ALS, spinal cord injury or chronic brain injury and need an assistive communication device
- Must be able to engage in volitional eye opening and sustain eye opening independently for at least 30 minutes.
- 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, independent 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
- Claustrophobia related to the Apple Vision Pro with comfort adapter
- 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
Cognixion HQ
Santa Barbara, California, 93101-1665
Chris Ullrich, M.Sc., 805-320-0774, chris@cognixion.com
Cole Heiner, M.A., 214-907-6399, cole@cognixion.com
About this study
Official title: Cognixion Pass Through Study
The goal of this study is refine the usability of a BCI capable communication platform.
The study will take place in the United States area and will enroll up to 10 participants with late stage ALS, traumatic brain injury (TBI) or spinal cord injury (SCI) that have assistive communication and computer control needs. Each subject will receive an integrated Cognixion + Apple Vision Pro device that includes an augmented reality brain computer interface and associated communication software. The study duration is 3-4 months for each participant.
Read more
The key questions that will be addressed in this study are:
- Identify the ability of individuals with target indications to use the integrated Cognixion-Apple Vision Pro system to communicate effectively.
- Identify the ability of such individuals to learn to use BCI, ET-BCI and other modalities, and to measure their progress over time.
- Identify the effectiveness of the different forms of input supported by the combined Cognixion-Apple Vision Pro system (BCI, eye-tracking) in allowing such individuals to communicate and have agency.
- Identify how input such as BCI can be optimized to suit the needs of individuals (e.g., specific frequencies that work best for an individual, SNR with different frequencies, number of targets, length of recording for each frequency) and improve overall usability.
- Identify the extent to which personalization through a large language model (LLM) affects communication.
- Identify the appropriate capabilities to enable through an agentic communication interface.
Key measures include:
ITR - information transfer rate SUS - system usability scale
- Conditions
- ALS (Amyotrophic Lateral Sclerosis), TBI Traumatic Brain Injury, SCI - Spinal Cord Injury, Stroke
- Being tested
- Cognixion + Apple Vision Pro
- Keywords
- usability study, augmented reality, brain computer interface, als, generative AI, agentic, spinal cord injury, traumatic brain injury
- Medical subject headings
- Amyotrophic Lateral Sclerosis, Brain Injuries, Traumatic, Spinal Cord Injuries, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognixion + Apple Vision ProDevice
An Apple Vision Pro device, integrated with Cognixion's brain sensing band and Assisted Reality software. The integrated device enables users to construct AI assisted communication and computer control commands using a combination of attention, eye gaze and head pose.
| Study group | Role | What they receive |
|---|---|---|
| Usability Study | Experimental | Participants will utilize the Cognixion + Apple Vision Pro device and associated communication and computer control software for practice and communication tasks as prescribed by the study administrator. Various modalities, including pure BCI and ET-BCI will be available to users. Receives: Device: Cognixion + Apple Vision Pro |
What is being measured
The primary outcome is the main question the study is designed to answer.
System Usabilty Score
A score ranging from 0 to 100 that captures the usability the device and enables it to be compared with other human machine interface devices. This is an intrisic property of the device interface (hardware/software) and is not a healh outcome measure.
Measured: 3-4 months
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 and is a measure the captures how efficient the device interface is. It is an essential measure of device throughput and is not related to any health outcome.
Measured: 3-4 months
Secondary outcomes (1)
Phrases per Minute
PPM is the number of complete phrases or compute rcommands that the user can construct in 1 minute. This is a usage metric that captures the efficiency of the device in predicting user utterances and does not relate to any health outcome.
Measured: 3-4 months from training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2025
- Study start16 Oct 2025 (estimated)
- Primary completion30 Apr 2026 (estimated)
- Study completion31 May 2026 (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
- Christopher J Ullrich, Principal investigator, Cognixion
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07209943
- Sponsor's protocol ID
- COG-AVP-002
- Status last verified
- Sep 2025
- First submitted
- 18 Sep 2025
- Last updated
- 7 Oct 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. This data will be anonymized prior to sharing.
Publications
Wolpaw 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 29950436Kellmeyer 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 29676287Lewis, J. R. (2018). The System Usability Scale: Past, Present, and Future. International Journal of Human-Computer Interaction, 34(7), 577-590
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognixion Pass Through Study
- ClinicalTrials.gov ID
- NCT07209943
- Acronym / sponsor ID
- COG-AVP-002
- Conditions
- ALS (Amyotrophic Lateral Sclerosis), TBI Traumatic Brain Injury, SCI - Spinal Cord Injury, Stroke
- Keywords
- usability study, augmented reality, brain computer interface, als, generative AI, agentic, spinal cord injury, traumatic brain injury
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- CognixionIndustry (pharma, biotech, devices)
- Study start
- 16 Oct 2025 (estimated)
- Primary completion
- 30 Apr 2026 (estimated)
- Study completion
- 31 May 2026 (estimated)
- First posted
- 7 Oct 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 capable communication platform.
The study will take place in the United States area and will enroll up to 10 participants with late stage ALS, traumatic brain injury (TBI) or spinal cord injury (SCI) that have assistive communication and computer control needs. Each subject will receive an integrated Cognixion + Apple Vision Pro device that includes an augmented reality brain computer interface and associated communication software. The study duration is 3-4 months for each participant.
The key questions that will be addressed in this study are:
- Identify the ability of individuals with target indications to use the integrated Cognixion-Apple Vision Pro system to communicate effectively.
- Identify the ability of such individuals to learn to use BCI, ET-BCI and other modalities, and to measure their progress over time.
- Identify the effectiveness of the different forms of input supported by the combined Cognixion-Apple Vision Pro system (BCI, eye-tracking) in allowing such individuals to communicate and have agency.
- Identify how input such as BCI can be optimized to suit the needs of individuals (e.g., specific frequencies that work best for an individual, SNR with different frequencies, number of targets, length of recording for each frequency) and improve overall usability.
- Identify the extent to which personalization through a large language model (LLM) affects communication.
- Identify the appropriate capabilities to enable through an agentic communication interface.
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 + Apple Vision ProParticipants will utilize the Cognixion + Apple Vision Pro device and associated communication and computer control software for practice and communication tasks as prescribed by the study administrator. Various modalities, including pure BCI and ET-BCI will be available to users. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Must have a designated on-site support individual who can be trained on the Cognixion system
- Fluent in understanding English
- 18 years or older
- Must have one of ALS, spinal cord injury or chronic brain injury and need an assistive communication device
- Must be able to engage in volitional eye opening and sustain eye opening independently for at least 30 minutes.
Key exclusion criteria (8 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
- Claustrophobia related to the Apple Vision Pro with comfort adapter
- History of epilepsy and/or seizures
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 + Apple Vision ProAn Apple Vision Pro device, integrated with Cognixion's brain sensing band and Assisted Reality software. The integrated device enables users to construct AI assisted communication and computer control commands using a combination of attention, eye gaze and head pose. | Device | Usability Study |
Primary outcome
System Usabilty Score
Time frame: 3-4 months
A score ranging from 0 to 100 that captures the usability the device and enables it to be compared with other human machine interface devices. This is an intrisic property of the device interface (hardware/software) and is not a healh outcome measure.
Information Transfer Rate (ITR)
Time frame: 3-4 months
The rate, in bits per minute, of information transfer for each of the device modalities. ITR is measured using a standardized selection procedure and is a measure the captures how efficient the device interface is. It is an essential measure of device throughput and is not related to any health outcome.
1 secondary outcome
Phrases per Minute
Time frame: 3-4 months from training
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 7 Oct 2025.
- 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.
- 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.
- BackgroundLewis, J. R. (2018). The System Usability Scale: Past, Present, and Future. International Journal of Human-Computer Interaction, 34(7), 577-590
- 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. This data will be anonymized prior to sharing.
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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.
Christopher J Ullrich 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 + Apple Vision Pro in people with ALS (Amyotrophic Lateral Sclerosis) and TBI Traumatic Brain Injury, 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 6 inclusion and 8 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: opening soon, as of the sponsor's last update on 7 Oct 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 Ullrich, M.Sc. (18053200774, chris@cognixion.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
System Usabilty Score (time frame: 3-4 months). 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 NCT07209943, 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 7 Oct 2025.