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

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.

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.