Connect-One: Early Feasibility Study of Connexus® Brain-Computer Interface (BCI) to Provide Human Connection Through Communication
Paradromics
Summary
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.
Eligibility
- Age range
- 22–75 years
- Sex
- All
- Healthy volunteers
- No
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 req…
Interventions
- DeviceConnexus Brain-Computer Interface
The Connexus Brain Computer Interface is an implantable brain-computer interface.
Locations (3)
- University of California, DavisSacramento, California
- Massachusetts General HospitalBoston, Massachusetts
- University of MichiganAnn Arbor, Michigan