Connexus Brain-Computer Interface for ALS

(CONNECT-ONE Trial)

Overseen By Paradromics Clinical Team

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Paradromics

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

2 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Are You a Good Fit for This Trial?

This trial is for individuals with severe communication or motor control impairments due to conditions like ALS, neuromuscular diseases, stroke, cervical cord injury, or dysarthria. Participants should be unable to speak or have significant difficulty with speech and voluntary muscle control.

Inclusion Criteria

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

I have a worsening muscle or nerve disease or injury.

Exclusion Criteria

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

Cognitive impairment or psychiatric illness that could impact the ability to comply with study requirements, as determined by the Study Investigator

What Are the Treatments Tested in This Trial?

Interventions

• Connexus Brain-Computer Interface

Trial Overview

The Connect-One study is testing the Connexus Brain-Computer Interface (BCI). This device aims to help people who can't move or talk well by decoding their thoughts into speech and allowing them to control computers using their minds.

How Is the Trial Designed?

Group I: Connect-One Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Paradromics

Lead Sponsor

University of Michigan

Collaborator

Trials

1,891

Recruited

6,458,000+