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

Part of paid clinical trials in Sacramento, California.

Sponsor
Paradromics
Study ID
NCT07357428
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
22 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Connexus Brain-Computer Interface — DEVICE
    The Connexus Brain Computer Interface is an implantable brain-computer interface.

Study Details

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.

Key Dates

Start date
Mar 31, 2026
Status verified
Apr 2026
Primary completion
May 31, 2027
Completion
Jan 31, 2032

Study Design

Enrollment
2 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER

Arms

  • Other: Connect-One

Primary Outcome Measure

Primary Safety: Number of Subjects With Device Related Adverse Events [ Time Frame: Up to 12 months post-implant ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
University of California, DavisSacramentoCalifornia95817
David Brandman M.D., Ph.D.
Massachusetts General HospitalBostonMassachusetts02114
Daniel Rubin, M.D., Ph.D.
University of MichiganAnn ArborMichigan48109
Matthew Willsey, M.D,. P.h.D

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