Connect-One: Early Feasibility Study of Connexus® Brain-Computer Interface (BCI) (NCT07357428) | Clinical Trial Compass
RecruitingNot Applicable
Connect-One: Early Feasibility Study of Connexus® Brain-Computer Interface (BCI)
United States2 participantsStarted 2026-03-31
Plain-language summary
The Connect-One Study is an early feasibility study to obtain preliminary device safety information for the Connexus Brain-Computer Interface (BCI). The Connexus BCI is intended to be used as: (1) an assistive communication device to decode imagined language correlates and speech for patients with impaired communication as a result of severe loss of voluntary motor control; and (2) to provide control of computer devices for individuals with severe loss of voluntary motor control of the upper extremity.
Who can participate
Age range
22 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Clinical diagnosis of a progressive neuromuscular disease or a neurological injury.
* Clinical diagnosis of anarthria or severe dysarthria.
* Wheelchair dependent with severely impaired upper limb function.
* Has a reliable method of communication and the ability to read and understand the English language.
* Has a study care partner (e.g. caregiver or multiple caregivers) for the duration of the study.
* Lives within a 4-hour radius of a study site.
Exclusion Criteria:
* Cognitive impairment or psychiatric illness that could impact the ability to comply with study requirements, as determined by the Study Investigator.
* Co-morbidities or an ongoing chronic medical condition that would impair the ability to comply with study requirements.
* The presence of another implanted device, like a pacemaker, deep brain stimulator, or implantable pulse generator.
* Requires, or is expected to require regular MRI scans for on-going medical conditions.
* In the opinion of the Study Investigator, the patient is not an appropriate candidate for the study, for reasons that could place the patient at undue risk or otherwise result in non-compliance with the study requirements.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Primary Safety: Number of Subjects With Device Related Adverse Events