A research study of a brain–computer interface communication device for people with ALS
Cognixion Corporation is conducting a research study comparing a wearable brain–computer interface (BCI) communication device with the eye-tracking communication devices people with ALS already use. The study runs at home over about 12 weeks. Approximately 30 people across the United States will take part.
To find out more
Contacting the study team does not commit you to anything. A short, no-obligation conversation is the first step, to see whether the study might be a fit.
Who may be able to take part
- Adults 18 years or older with a diagnosis of ALS
- Speech is significantly affected — difficult for others to understand, or no longer able to speak
- Currently use a Tobii Dynavox or Smartbox eye-tracking communication device (for at least 30 days) or evaluating using an eye tracking device
- Have a caregiver who can be trained and present for each session with the study device
- Can keep the eyes open for at least 30 minutes at a time (with normal blinking)
- Can see a display screen and smart glasses display clearly, with or without corrective lenses
- Can reliably answer yes or no by some means other than the study device (for example nodding, eye blink, or pupil motion)
- Able to read and understand English
Who cannot take part
- History of seizures, epilepsy, or sensitivity to flashing lights
- Certain vision conditions affecting the field of view, a history of vertigo or balance disorders, or a scalp condition that would make sensor placement unsafe
- Currently enrolled in another communication-device or BCI research study
The study team will review the full list of requirements with you.
What taking part involves
- About 12 weeks of regular practice, with the option to continue longer
- 3 to 5 sessions per week, about 1 hour each, in your own home
- Trying three communication options: your own eye-tracking device, a head-worn version of the study device, and a screen-based version
- For some sessions you choose which option to use — that choice is part of what is being studied
- A study team member checks in weekly by phone or video, and visits in person about once a month
- A short 10-minute ALS questionnaire every 4 weeks
- Equipment is delivered and set up in your home, and your caregiver is trained by the study team
Cost and payment
- Participants may be allowed to keep study equipment at end of study.
- No cost to take part. All equipment and supplies are provided.
- No payment is offered for taking part.
Please read before you get in touch
This is a research study, not medical treatment. The Cognixion ONE device is an investigational research device. It is not approved or cleared by the U.S. Food and Drug Administration for any medical use, and there is no guarantee that anyone taking part will benefit from it.
There are risks, including discomfort from wearing the device, skin irritation, and fatigue. The study team will go through all of the risks, and the full consent form, with you and your caregiver before you decide anything.
Taking part is entirely voluntary. You may decide not to join, or stop at any time, without affecting your medical care or your relationship with the organization that told you about this study. Your regular ALS care continues unchanged.
More information
- Full study record on ClinicalTrials.gov: NCT07871071
- Printable one-page summary: download the study flyer (PDF)