Early study of a brain-computer interface for people with severe loss of movement
Tests a brain-computer interface device for communication in people with severe movement loss.
Plain-language title generated from the registry record
Registry title: Connect-One: Early Feasibility Study of Connexus® Brain-Computer Interface (BCI)
Key facts
- Where
- Ann Arbor, Boston, and Sacramento, United StatesSee the 3 sites
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 22 and 75 years old?
Source: NCT07357428, who can take part
Where in United States
- University of MichiganAnn Arbor, United StatesTaking people
- Massachusetts General HospitalBoston, United StatesTaking people
- University of California - DavisSacramento, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Paradromics
- Trial code
- NCT07357428
- Record updated
- 14 April 2026
- Original description
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.Read full original descriptionShow less
Connect-One: Early Feasibility Study of Connexus® Brain-Computer Interface (BCI) to Provide Human Connection Through Communication
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.
Inclusion: 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: 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; Requires, or is expected to require regular MRI scans for on-going medical conditions; The presence of another implanted device, like a pacemaker, deep brain stimulator, or implantable pulse generator; 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.