Actively Recruiting
Connect-One: Early Feasibility Study of Connexus® Brain-Computer Interface (BCI)
Led by Paradromics · Updated on 2026-04-14
2
Participants Needed
3
Research Sites
300 weeks
Total Duration
On this page
Sponsors
P
Paradromics
Lead Sponsor
U
University of Michigan
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Connect-One: Early Feasibility Study of Connexus® Brain-Computer Interface (BCI)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
University of California, Davis
Sacramento, California, United States, 95817
Actively Recruiting
2
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
3
University of Michigan
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
Research Team
P
Paradromics Clinical Team
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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