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Connect-One: Early Feasibility Study of Connexus® Brain-Computer Interface (BCI)
Connect-One: Early Feasibility Study of Connexus® Brain-Computer Interface (BCI) to Provide Human Connection Through Communication
Who can join
Ages 22 to 75 · All sexes
Full eligibility criteria
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.
About the study
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.
What is being tested
- Connexus Brain-Computer Interface (device)
Sponsor: Paradromics · Participants: 2 · Started: Mar 31, 2026
Contact the study team
- Paradromics Clinical Team · Phone: (512) 559 4120
Official record on ClinicalTrials.gov — NCT07357428
Locations in the U.S.
| California | University of California, Davis, Sacramento |
| Massachusetts | Massachusetts General Hospital, Boston |
| Michigan | University of Michigan, Ann Arbor |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.