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Connect-One: Early Feasibility Study of Connexus® Brain-Computer Interface (BCI) to Provide Human Connection Through Communication

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 22
Maximum Age: 75
Healthy Volunteers: f
View:

• 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.

Locations
United States
California
University of California, Davis
RECRUITING
Sacramento
Massachusetts
Massachusetts General Hospital
RECRUITING
Boston
Michigan
University of Michigan
RECRUITING
Ann Arbor
Contact Information
Primary
Paradromics Clinical Team
clinical-team@paradromics.com
(512) 559 4120
Time Frame
Start Date: 2026-03-31
Estimated Completion Date: 2032-01
Participants
Target number of participants: 2
Treatments
Other: Connect-One
Sponsors
Leads: Paradromics
Collaborators: University of Michigan, Massachusetts General Hospital, University of California, Davis

This content was sourced from clinicaltrials.gov