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Connect-One Study of Connexus® Brain-Computer Interface

The Connect-One Study is an early study testing the safety of a device called the Connexus Brain-Computer Interface (BCI). This device is implanted in the brain and is designed to help people with severe communication problems or limited arm movement. It aims to decode imagined thoughts into language or allow control of computer devices. This study is looking for people aged 22 to 75 who have a progressive neuromuscular disease (a condition affecting nerves and muscles) or a neurological injury (like a stroke or spinal cord injury), have severe speech difficulties, are in a wheelchair, and can communicate reliably. The main goal is to see how safe the Connexus BCI is by tracking any device-related side effects for up to 12 months after it's implanted. The current status of this study is unclear.

Study design
This is an interventional study, meaning participants will receive the Connexus Brain-Computer Interface. It is an early feasibility study with a planned enrollment of 2 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to 12 months after the device is implanted to monitor for any device-related adverse events.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07357428

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

Recruiting
NAAges 22–75Interventional
Paradromics
~2 participants
Updated 2026-04-14 on ClinicalTrials.gov
What's tested:Connexus Brain-Computer Interface

At a glance

Recruiting sites
3 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Primary Safety: Number of Subjects With Device Related Adverse Events
Measured over Up to 12 months post-implant

Conditions

Amyotrophic Lateral Sclerosis
Neuromuscular Disease
Stroke
Tetraplegia/Tetraparesis
Cervical Spinal Cord Injury
Dysarthria

Explore related trials

Amyotrophic Lateral SclerosisCervical spinal cord injuryDysarthriaNeuromuscular DisorderQuadriplegiaStroke

Where it's being run

3 sites across 3 states
California1
Massachusetts1
Michigan1

Who to contact

Paradromics Clinical Team
[email protected]
(512) 559 4120
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Primary Safety: Number of Subjects With Device Related Adverse EventsUp to 12 months post-implant

    Device Related Adverse Events: Number of subjects with device-related adverse events