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

Status: Recruiting
Location: See location...
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
Michigan
University of Michigan
RECRUITING
Ann Arbor
Contact Information
Primary
Paradromics Clinical Team
clinical-team@paradromics.com
(512) 559 4120
Time Frame
Start Date: 2026-01
Estimated Completion Date: 2032-01
Participants
Target number of participants: 2
Treatments
Other: Connect-One
Sponsors
Leads: Paradromics
Collaborators: University of Michigan

This content was sourced from clinicaltrials.gov

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