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

NCT07357428 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2026-04-14

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

Connexus Brain-Computer Interface

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

Sponsors & Collaborators

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
22 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-31
Primary Completion
2027-05-31
Completion
2032-01-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07357428 on ClinicalTrials.gov