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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
2
The Connexus Brain Computer Interface is an implantable brain-computer interface.
University of Michigan
Ann Arbor, Michigan, United States
RECRUITINGPrimary Safety: Number of Subjects With Device Related Adverse Events
Device Related Adverse Events: Number of subjects with device-related adverse events
Time frame: Up to 12 months post-implant
Long-Term Safety: Number of Subjects With Device Related Adverse Events
Device Related Adverse Events: Number of subjects with device-related adverse events
Time frame: Up to 6 years post-implant
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