Actively Recruiting
Connect-One: Early Feasibility Study of Connexus4 Brain-Computer Interface (BCI) to Provide Human Connection Through Communication
Led by Paradromics · Updated on 2026-04-14
2
Participants Needed
3
Research Sites
243 weeks
Total Duration
On this page
Sponsors
P
Paradromics
Lead Sponsor
U
University of Michigan
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the Connexus Brain-Computer Interface (BCI) in an early feasibility study to gather initial safety data. The Connexus BCI is designed to help people with severe loss of voluntary motor control, enabling communication by decoding imagined language and speech. It also aims to assist with controlling computer devices for individuals with impaired upper limb function due to conditions like amyotrophic lateral sclerosis, stroke, or spinal cord injury. The study involves implanting the Connexus Brain-Computer Interface device, which is an implantable technology. Participants will use the device to explore its potential as an assistive communication tool and control aid. The study will monitor safety outcomes related to the device over periods extending up to 12 months initially and up to 6 years for long-term safety. Participants will be closely followed with assessments focusing on device-related adverse events. The research team will evaluate both primary safety within the first year after implantation and long-term safety over several years. Participants will need a care partner and live within a reasonable distance from the study site to support their involvement throughout the study duration.
CONDITIONS
Brief 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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 1 day
Participants undergo implantation of the Connexus Brain-Computer Interface device.
1 implantation visit (in-person)
Duration - Up to 12 months post-implant
Participants are monitored for device safety and function after implantation.
Regular follow-up visits during the first year
Duration - Up to 6 years post-implant
Participants are followed for long-term device safety and outcomes.
Periodic visits over 6 years
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
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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