Connect-One: Early Feasibility Study of Connexus® Brain-Computer Interface (BCI)
Paradromics · with University of Michigan, University of California, Davis · NCT07357428
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 22–75 · All sexes
- Healthy volunteers
- Not accepted (a condition is required)
- Study type
- Interventional · Not applicable
- Target enrollment
- 2
- US sites recruiting
- 3
- Study start
- March 31, 2026
- Record last updated
- April 14, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study 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.
Being studied: Connexus Brain-Computer Interface
Conditions: Amyotrophic Lateral Sclerosis; Neuromuscular Disease; Stroke; Tetraplegia/Tetraparesis; Cervical Spinal Cord Injury; Dysarthria
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full 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.
Recruiting US locations
University of California, Davis
Sacramento, CA 95817
Site contact: David Brandman M.D., Ph.D.
Massachusetts General Hospital
Boston, MA 02114
Site contact: Daniel Rubin, M.D., Ph.D.
University of Michigan
Ann Arbor, MI 48109
Site contact: Matthew Willsey, M.D,. P.h.D
Study contacts (from the official record)
- Paradromics Clinical Team · (512) 559 4120 · clinical-team@paradromics.com
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