Clinical Trial

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

Study acronym: CONNECT-ONE
Recruiting
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Summary
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.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2026-01-20; most recent amendment 2026-04-09.
Trial Details
NCT Number NCT07357428
Lead Sponsor Paradromics
Collaborators: University of Michigan, University of California, Davis, Massachusetts General Hospital
Conditions Amyotrophic Lateral Sclerosis, Neuromuscular Disease, Stroke, Tetraplegia/Tetraparesis, Cervical Spinal Cord Injury, Dysarthria
Enrollment 2 participants
Start Date 2026-03-31
Primary Completion 2027-05 (estimated)
Study Completion 2032-01 (estimated)
Updated on ClinicalTrials.gov 2026-04-14