NCT07357428Recruiting
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
Source: ClinicalTrials.gov · Last updated 14 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 2 (estimated)
- First submitted
- 23 Dec 2025
- Start date
- Mar 2026
- Primary completion date
- May 2027
- Lead sponsor
- Paradromics
- Diseases
- ALS (motor neurone disease), Stroke
- NCT number
- NCT07357428
What you commit to
- Study type: Interventional
- Planned participants: 2
- From Mar 2026 to the primary completion date, May 2027
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 22 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Michigan Coordinator of this site? Confirm its status | Ann Arbor | United States | Recruiting |
| Massachusetts General Hospital Coordinator of this site? Confirm its status | Boston | United States | Recruiting |
| University of California - Davis Coordinator of this site? Confirm its status | Sacramento | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.