Amyotrophic Lateral Sclerosis, Cervical Spinal Cord Injury, Dysarthria, Neuromuscular Disease, Stroke, Tetraplegia/Tetraparesis
Conditions
Keywords
BCI, ALS, Paradromics, speech, dysarthria, neural injury, progressive neuromuscular disease, stroke, assistive technology, communication device, brain computer interface
Brief 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.
Interventions
DEVICEConnexus Brain-Computer Interface
The Connexus Brain Computer Interface is an implantable brain-computer interface.
Sponsors
Paradromics
University of Michigan
University of California, Davis
Massachusetts General Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
22 Years to 75 Years
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 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Safety: Number of Subjects With Device Related Adverse Events | Up to 12 months post-implant | Device Related Adverse Events: Number of subjects with device-related adverse events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Long-Term Safety: Number of Subjects With Device Related Adverse Events | Up to 6 years post-implant | Device Related Adverse Events: Number of subjects with device-related adverse events |
Countries
United States
Contacts
CONTACTParadromics Clinical Team
Outcome results
None listed