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.
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.
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.
Single group
Connexus Brain-Computer Interface
DeviceThe Connexus Brain Computer Interface is an implantable brain-computer interface.
Primary Safety: Number of Subjects With Device Related Adverse Events
Device Related Adverse Events: Number of subjects with device-related adverse events
Long-Term Safety: Number of Subjects With Device Related Adverse Events
Device Related Adverse Events: Number of subjects with device-related adverse events
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Paradromics
Lead sponsor
University of Michigan
Collaborator
University of California, Davis
Collaborator
Massachusetts General Hospital
Collaborator
