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

April 9, 2026 updated by: Paradromics

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

2

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • Sacramento, California, United States, 95817
        • Recruiting
        • University of California, Davis
        • Contact:
          • David Brandman M.D., Ph.D.
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Recruiting
        • Massachusetts General Hospital
        • Contact:
          • Daniel Rubin, M.D., Ph.D.
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Recruiting
        • University of Michigan
        • Contact:
          • Matthew Willsey, M.D,. P.h.D

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Cognitive impairment or psychiatric illness that could impact the ability to comply with study requirements, as determined by the Study Investigator.
  • Co-morbidities or an ongoing chronic medical condition that would impair the ability to comply with study requirements.
  • The presence of another implanted device, like a pacemaker, deep brain stimulator, or implantable pulse generator.
  • Requires, or is expected to require regular MRI scans for on-going medical conditions.
  • In the opinion of the Study Investigator, the patient is not an appropriate candidate for the study, for reasons that could place the patient at undue risk or otherwise result in non-compliance with the study requirements.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Connect-One
Device: Connexus Brain-Computer Interface
The Connexus Brain Computer Interface is an implantable brain-computer interface.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Primary Safety: Number of Subjects With Device Related Adverse Events
Time Frame: Up to 12 months post-implant
Device Related Adverse Events: Number of subjects with device-related adverse events
Up to 12 months post-implant

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Long-Term Safety: Number of Subjects With Device Related Adverse Events
Time Frame: Up to 6 years post-implant
Device Related Adverse Events: Number of subjects with device-related adverse events
Up to 6 years post-implant

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Paradromics

Collaborators

Massachusetts General Hospital
University of Michigan
University of California, Davis

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 31, 2026

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

January 1, 2032

Study Registration Dates

First Submitted

December 23, 2025

First Submitted That Met QC Criteria

January 20, 2026

First Posted (Actual)

January 22, 2026

Study Record Updates

Last Update Posted (Actual)

April 14, 2026

Last Update Submitted That Met QC Criteria

April 9, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRT-1014

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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