TrialPath
← Back to searchRecruiting

Connect-One: Early Feasibility Study of Connexus® Brain-Computer Interface (BCI)

NCT07357428 · Paradromics
In plain English

Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.

Official title
Connect-One: Early Feasibility Study of Connexus® Brain-Computer Interface (BCI) to Provide Human Connection Through Communication
About this 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.
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.
Study design
Enrollment target: 2 participants
Allocation: na
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2026-03-31
Estimated completion: 2032-01
Last updated: 2026-04-14
Interventions
Device: Connexus Brain-Computer Interface
Primary outcomes
  • Primary Safety: Number of Subjects With Device Related Adverse Events (Up to 12 months post-implant)
Sponsor
Paradromics · industry
With: University of Michigan, University of California, Davis, Massachusetts General Hospital
Contacts & investigators
ContactParadromics Clinical Team · contact · clinical-team@paradromics.com · (512) 559 4120
All locations (3)
University of California, DavisRecruiting
Sacramento, California, United States
Massachusetts General HospitalRecruiting
Boston, Massachusetts, United States
University of MichiganRecruiting
Ann Arbor, Michigan, United States
Connect-One: Early Feasibility Study of Connexus® Brain-Computer Interface (BCI) · TrialPath