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RECRUITINGNA

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

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

NCT07357428•Paradromics

View on ClinicalTrials.gov

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

Age

22 - 75 years

Sex

ALL

Healthy Volunteers

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.

Locations (1)

University of Michigan

Ann Arbor, Michigan, United States

Key Dates

Start Date

January 1, 2026

Primary Completion Date

May 1, 2027

Completion Date

January 1, 2032

Last Updated

January 22, 2026

Enrollment

ESTIMATED participants

Conditions

Amyotrophic Lateral SclerosisNeuromuscular DiseaseStrokeTetraplegia/TetraparesisCervical Spinal Cord InjuryDysarthria

Interventions

Connexus Brain-Computer Interface

DEVICE

Contacts

Paradromics Clinical Team

CONTACT

(512) 559 4120 clinical-team@paradromics.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 22, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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